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Efficacy and Safety of MK-8189 in Participants With an Acute Episode of Schizophrenia (MK-8189-008)

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MK-8189
Risperidone
Placebo to MK-8189
Placebo to risperidone
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The main inclusion criteria include, but are not limited to the following:

  • Meet the diagnostic criteria for schizophrenia according to the DSM-5
  • Have an illness duration for schizophrenia of at least 1 year
  • Be confirmed to be experiencing an acute episode of schizophrenia as evidenced by ALL of the following: (a) onset of the current acute episode is ≤6 weeks before screening (b) current symptoms represent a marked and substantial worsening compared with the participant's usual symptomatic state prior to the current acute episode, and are associated with diminished functional ability (c) in need of increased psychiatric attention to treat worsening acute episode symptoms
  • Have a CGI-S score of ≥4 (moderately ill) at screening and baseline
  • Have an identified responsible person referred to as the "external contact person" who has agreed to provide information about the participant's location if needed during outpatient portion of the study. The site personnel must consider this identified responsible person a reliable contact person, and the contact person must have regular contact with the participant (defined at screening as direct contact no fewer than 3 times per week), and with the expectation that this frequency of contact would continue (either in person or via other contact method), throughout duration of the study, including the follow-up period)

Exclusion Criteria:

The main exclusion criteria include, but are not limited to the following:

  • Has a primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment
  • Meets criteria for moderate to severe substance use disorder within past 6 months prior to screening (excluding those related to caffeine or nicotine)
  • Has a known history of the following: (a) borderline personality disorder, anti-social personality disorder, or bipolar disorder (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease, or another form of dementia, or any chronic organic disease of the central nervous system (c) intellectual disability of a severity that would impact ability to participate in the study
  • Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse
  • Is or was under involuntary commitment for the acute episode, because the participant is considered a danger to themselves or others
  • Has a history of treatment resistance exhibited by any of the following: (a) no or minimal response to at least 2 periods of treatment lasting 6 weeks or longer, with antipsychotic agents at the maximally tolerated dose. Participants who have responded to antipsychotics only when paired with clozapine are considered treatment-resistant (b) history of electroconvulsive therapy (ECT) treatment for treatment-resistant schizophrenia within the past 6 months (c) past or current use of clozapine as single or adjunctive therapy for schizophrenia within the past 3 months
  • Is currently participating in or has participated in another clinical study and received an experimental or investigational drug agent within 3 months prior to screening visit of this current study and has participated in no more than 2 studies in the past 2 years

Sites / Locations

  • Pillar Clinical Research ( Site 1047)Recruiting
  • Woodland International Research Group, LLC ( Site 1002)Recruiting
  • Woodland Research Northwest, LLC ( Site 1036)Recruiting
  • CITRIALS ( Site 1010)Recruiting
  • ProScience Research Group ( Site 1046)Recruiting
  • Collaborative Neuroscience Research, LLC ( Site 1041)Recruiting
  • Behavioral Research Specialists, LLC ( Site 1032)
  • CITRIALS ( Site 1016)Recruiting
  • Artemis Institute for Clinical Research ( Site 1019)
  • California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) ( Site 103Recruiting
  • Schuster Medical Research Institute ( Site 1023)Recruiting
  • Behavioral Clinical Research ( Site 1058)Recruiting
  • Behavioral Clinical Research , Inc ( Site 1013)
  • Premier Clinical Research Institute ( Site 1049)Recruiting
  • Fort Lauderdale Behavioral Health Center ( Site 1028)
  • Research Centers of America ( Fort Lauderdale ) ( Site 1065)Recruiting
  • Health Synergy Clinical Research ( Site 1051)Recruiting
  • Atlanta Center For Medical Research ( Site 1022)Recruiting
  • iResearch Atlanta ( Site 1039)Recruiting
  • Ascension Saint Elizabeth ( Site 1000)Recruiting
  • Uptown Research Institute ( Site 1052)Recruiting
  • Pillar Clinical Research, LLC ( Site 1038)Recruiting
  • Benchmark Research ( Site 1054)Recruiting
  • CBH Health ( Site 1044)Recruiting
  • Massachusetts General Hospital ( Site 1035)
  • Arch Clinical Trials ( Site 1048)Recruiting
  • Altea Research Institute ( Site 1012)
  • Hassman Research Institute Marlton Site ( Site 1040)Recruiting
  • Richmond Behavioral Associates ( Site 1064)Recruiting
  • New Hope Clinical Research ( Site 1050)
  • Midwest Clinical Research ( Site 1059)Recruiting
  • Midwest Clinical Research Center ( Site 1033)
  • Neuro-Behavioral Clinical Research ( Site 1055)Recruiting
  • Community Clinical Research ( Site 1057)Recruiting
  • Pillar Clinical Research, LLC ( Site 1004)Recruiting
  • State Psychiatric Hospital "Sv. Ivan Rilski", Novi Iskar ( Site 3001)Recruiting
  • Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD ( Site 3002)Recruiting
  • State Psychiatric Hospital - Kardzhali ( Site 3005)Recruiting
  • Mental Health Center - Ruse, EOOD ( Site 3003)Recruiting
  • Center for Mental Health Prof. Nikola Shipkovenski Ltd ( Site 3000)Recruiting
  • Mental Health Center - Veliko Tarnovo ( Site 3006)Recruiting
  • Klinika za psihijatriju Vrapce ( Site 4000)Recruiting
  • Klinika za psihijatriju Vrapce ( Site 4001)Recruiting
  • Klinicki bolnicki centar Rijeka ( Site 4005)Recruiting
  • Klinika za psihijatriju Sveti Ivan ( Site 4003)Recruiting
  • Seishinkai Okehazama Hospital Fujita Kokoro Care Center ( Site 2011)Recruiting
  • Kohnodai Hospital, National Center for Global Health and Medicine ( Site 2005)Recruiting
  • Wakato Hospital ( Site 2031)
  • Shiranui Hospital ( Site 2043)Recruiting
  • Seimou Hospital ( Site 2004)Recruiting
  • Soushu Hospital ( Site 2008)
  • Tanzawa Hospital ( Site 2037)Recruiting
  • Kanagawa Psychiatric Center ( Site 2035)Recruiting
  • Komoro Kogen Hospital ( Site 2046)Recruiting
  • National Hospital Organization Ryukyu Hospital ( Site 2019)
  • Amekudai Hospital ( Site 2020)Recruiting
  • National Hospital Organization Hizen Psychiatric Medical Center ( Site 2017)Recruiting
  • Rainbow and Sea Hospital ( Site 2016)Recruiting
  • Ongata Hospital ( Site 2007)
  • Nishigahara Hospital ( Site 2042)
  • National Center of Neurology and Psychiatry ( Site 2023)Recruiting
  • Chiba University Hospital ( Site 2024)Recruiting
  • Inokuchi Noma Hospital ( Site 2030)Recruiting
  • Kuramitsu Hospital ( Site 2014)Recruiting
  • Yuge Hospital ( Site 2018)
  • Seijin Hospital ( Site 2026)Recruiting
  • Narimasu Kosei Hospital ( Site 2006)Recruiting
  • Inje University Busan Paik Hospital ( Site 0604)Recruiting
  • Kyungpook National University Hospital ( Site 0601)Recruiting
  • Seoul National University Hospital ( Site 0600)
  • Daugavpils Psihoneirologiska Slimnica ( Site 8005)
  • Piejuras Slimnica Psihiatriska Klinika ( Site 8001)
  • Specjal. Psychiatryczny ZOZ w Lodzi, Szpital im. Babinskiego ( Site 0905)Recruiting
  • Klinika Psychiatryczna Wydzialu Nauki o Zdrowiu WUM ( Site 0900)Recruiting
  • Samodzielny Wojewódzki Zespół Publicznych Zakładów Psychiatrycznej Opieki Zdrowotnej w Warszawie ( SRecruiting
  • Uniwersyteckie Centrum Kliniczne ( Site 0902)Recruiting
  • Centrum Medyczne HCP ( Site 0913)Recruiting
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0815)Recruiting
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0816)Recruiting
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0817)Recruiting
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0818)Recruiting
  • Institutul de Psihiatrie Socola ( Site 0810)Recruiting
  • Institutul de Psihiatrie Socola ( Site 0814)Recruiting
  • Arkhangelsk Regional Psychiatric Clinical Hospital ( Site 6020)
  • SGHI Leningrad Region Psyconeurology Dispensary ( Site 6017)
  • Lipetsk Regional Psychoneurology Hospital ( Site 6021)
  • Moscow Scientific Research Institute for Psychiatry ( Site 6013)
  • Psychiatric Clinical Hospital 4 named after PB Gannushkin ( Site 6016)
  • Psychiatric Clinical Hospital 4 named after PB Gannushkin-Psychiatric department 4 ( Site 6023)
  • Central Moscow Regional Clinical Psychiatric Hospital ( Site 6018)
  • Bekhterev Research Institute for Psychoneurology ( Site 6008)
  • SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6000)
  • SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6001)
  • SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6002)
  • Stavropol Region Psychiatric Hospital #2 ( Site 6005)
  • Federal State Scientific Institution Research Institute of Mental Health ( Site 6014)
  • Yaroslavl Regional Clinical Psychiatry Hospital ( Site 6022)
  • Clinical Center Kragujevac ( Site 5100)Recruiting
  • Clinical Center Kragujevac ( Site 5102)Recruiting
  • Clinical Center Kragujevac ( Site 5106)Recruiting
  • Special Hospital for Psychiatric Diseases Kovin ( Site 5108)Recruiting
  • Special Hospital for Psychiatric Diseases Kovin ( Site 5109)Recruiting
  • China Medical University Hospital ( Site 9006)
  • National Taiwan University Hospital ( Site 9001)Recruiting
  • Taipei City Hospital, Songde Branch ( Site 9004)
  • Taipei Veterans General Hospital ( Site 9000)
  • Chang Gung Memorial Hospital - Linkou Branch ( Site 9002)
  • CNE Cherkasy reg. psychiatric hospital of Cherkasy regional council ( Site 7009)
  • Dnepropetrovsk Regional Clinical Hospital Mechnikov-Regional Centre of Psychosomatic Disorders base
  • CNE "Precarpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council"" (
  • CNE of Kharkiv Reg. Council Reg. Clinical Psychiatric Hospital Nub 3 ( Site 7012)
  • Institute of Neurology,Psychiatry and Narcology AMS Ukraine ( Site 7011)
  • CNE. Kherson Regional Psychiatric Hospital ( Site 7004)
  • Kyiv City Psychoneurological Hospital 2 ( Site 7008)
  • CNE Clinical Hospital PSYCHIATRY of executive body of Kyiv City Council -Kyiv City State Admin ( Sit
  • MNE of KRC-Regional psychiatric and narcological medical association ( Site 7005)
  • Reg. Psych. Hosp. n.a. O. Yuschenko, Dept #21, VNMU n.a. M.Pirogov ( Site 7001)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Arm Label

MK-8189 8 mg (Acute) - MK-8189 8 mg (Extension)

MK-8189 16 mg (Acute) - MK-8189 16 mg (Extension)

MK-8189 24 mg (Acute) - MK-8189 24 mg (Extension)

Risperidone 6 mg (Acute) - Risperidone 6 mg (Extension)

Placebo to MK-8189 (Acute) - MK-8189 24 mg (Extension)

Arm Description

Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 8 mg once daily (QD) in the acute treatment period from Week 1-6 followed by MK-8189 8 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12. Enrollment of participants in the MK-8189 8 mg arm was closed with Amendment 4. Participants enrolled before Amendment 4 that have been assigned to 8 mg MK-8189 will remain on 8 mg MK-8189 per protocol.

Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 16 mg QD in the acute treatment period from Week 1-6 followed by MK-8189 16 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.

Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 24 mg QD in the acute treatment period from Week 1-6 followed by MK-8189 24 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.

Participants will be treated for a total of 12 weeks. Participants will receive risperidone 6 mg QD in the acute treatment period from Week 1-6 followed by risperidone 6 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive MK-8189-matching placebo QD from Week 1-12.

Participants will be treated for a total of 12 weeks. Participants will receive MK-8189-matching placebo QD in the acute treatment period from Week 1-6 followed by MK-8189 24 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.

Outcomes

Primary Outcome Measures

Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
The PANSS assesses the severity of schizophrenia symptoms through a 30-item clinician-rated inventory organized into a positive subscale (7 items), a negative subscale (7 items) and a general psychopathology subscale (16 items). For each item, symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score for each participant will be calculated as the sum of the rating assigned to each of the 30 PANSS items and will range from 30 (lowest total score) to 210 (highest total score). Higher scores reflect more severe symptoms of schizophrenia.
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study treatment due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention.

Secondary Outcome Measures

Change from baseline in PANSS positive subscale (PSS) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
The PANSS Positive Subscale (PSS) assesses the severity of schizophrenia symptoms and the PANSS PSS score for each participant will be calculated as the sum of the rating assigned to each of the 7 PSS items and will range from 7 (lowest total score) to 49 (highest total score). Higher scores reflect more severe symptoms of schizophrenia.
Change from baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
The CGI-S is a single item 7-point clinician rated scale for assessing the global severity of the participant's illness. CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill). A decrease in the CGI-S score indicates reduced severity of the participant's illness.
Change from baseline in weight at Week 12: MK-8189 24 mg, MK-8189 16 mg, or risperidone
Body weight will be measured using a standardized scale.
Change from baseline in weight at Week 6: MK-8189 24 mg, MK-8189 16 mg, MK-8189 8 mg or placebo
Body weight will be measured using a standardized scale.

Full Information

First Posted
November 5, 2020
Last Updated
October 19, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04624243
Brief Title
Efficacy and Safety of MK-8189 in Participants With an Acute Episode of Schizophrenia (MK-8189-008)
Official Title
A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
June 19, 2024 (Anticipated)
Study Completion Date
June 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. The primary hypotheses are the following: (1) MK-8189 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score (2) MK-8189 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score. With Amendment 4, enrollment was changed to approximately 500 participants with removal of the MK-8189 8 mg treatment arm. Participants enrolled before Amendment 4 that have been assigned to 8 mg MK-8189 will remain on 8 mg MK-8189 per protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MK-8189 8 mg (Acute) - MK-8189 8 mg (Extension)
Arm Type
Experimental
Arm Description
Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 8 mg once daily (QD) in the acute treatment period from Week 1-6 followed by MK-8189 8 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12. Enrollment of participants in the MK-8189 8 mg arm was closed with Amendment 4. Participants enrolled before Amendment 4 that have been assigned to 8 mg MK-8189 will remain on 8 mg MK-8189 per protocol.
Arm Title
MK-8189 16 mg (Acute) - MK-8189 16 mg (Extension)
Arm Type
Experimental
Arm Description
Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 16 mg QD in the acute treatment period from Week 1-6 followed by MK-8189 16 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.
Arm Title
MK-8189 24 mg (Acute) - MK-8189 24 mg (Extension)
Arm Type
Experimental
Arm Description
Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 24 mg QD in the acute treatment period from Week 1-6 followed by MK-8189 24 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.
Arm Title
Risperidone 6 mg (Acute) - Risperidone 6 mg (Extension)
Arm Type
Active Comparator
Arm Description
Participants will be treated for a total of 12 weeks. Participants will receive risperidone 6 mg QD in the acute treatment period from Week 1-6 followed by risperidone 6 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive MK-8189-matching placebo QD from Week 1-12.
Arm Title
Placebo to MK-8189 (Acute) - MK-8189 24 mg (Extension)
Arm Type
Experimental
Arm Description
Participants will be treated for a total of 12 weeks. Participants will receive MK-8189-matching placebo QD in the acute treatment period from Week 1-6 followed by MK-8189 24 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.
Intervention Type
Drug
Intervention Name(s)
MK-8189
Intervention Description
MK-8189 administered QD at a dose of 8 mg, 16 mg, or 24 mg via oral tablet.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Risperidone administered QD at a dose of 6 mg via oral capsule.
Intervention Type
Drug
Intervention Name(s)
Placebo to MK-8189
Intervention Description
MK-8189-matching placebo administered QD via oral tablet.
Intervention Type
Drug
Intervention Name(s)
Placebo to risperidone
Intervention Description
Risperidone-matching placebo administered QD via oral capsule.
Primary Outcome Measure Information:
Title
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
Description
The PANSS assesses the severity of schizophrenia symptoms through a 30-item clinician-rated inventory organized into a positive subscale (7 items), a negative subscale (7 items) and a general psychopathology subscale (16 items). For each item, symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score for each participant will be calculated as the sum of the rating assigned to each of the 30 PANSS items and will range from 30 (lowest total score) to 210 (highest total score). Higher scores reflect more severe symptoms of schizophrenia.
Time Frame
Baseline, Week 6
Title
Number of participants who experience one or more adverse events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
~Up to Week 14
Title
Number of participants who discontinue study treatment due to an AE
Description
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
~Up to Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in PANSS positive subscale (PSS) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
Description
The PANSS Positive Subscale (PSS) assesses the severity of schizophrenia symptoms and the PANSS PSS score for each participant will be calculated as the sum of the rating assigned to each of the 7 PSS items and will range from 7 (lowest total score) to 49 (highest total score). Higher scores reflect more severe symptoms of schizophrenia.
Time Frame
Baseline, Week 6
Title
Change from baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
Description
The CGI-S is a single item 7-point clinician rated scale for assessing the global severity of the participant's illness. CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill). A decrease in the CGI-S score indicates reduced severity of the participant's illness.
Time Frame
Baseline, Week 6
Title
Change from baseline in weight at Week 12: MK-8189 24 mg, MK-8189 16 mg, or risperidone
Description
Body weight will be measured using a standardized scale.
Time Frame
Baseline, Week 12
Title
Change from baseline in weight at Week 6: MK-8189 24 mg, MK-8189 16 mg, MK-8189 8 mg or placebo
Description
Body weight will be measured using a standardized scale.
Time Frame
Baseline, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include, but are not limited to the following: Meet the diagnostic criteria for schizophrenia according to the DSM-5 Have an illness duration for schizophrenia of at least 1 year Be confirmed to be experiencing an acute episode of schizophrenia as evidenced by ALL of the following: (a) onset of the current acute episode is ≤6 weeks before screening (b) current symptoms represent a marked and substantial worsening compared with the participant's usual symptomatic state prior to the current acute episode, and are associated with diminished functional ability (c) in need of increased psychiatric attention to treat worsening acute episode symptoms Have a CGI-S score of ≥4 (moderately ill) at screening and baseline Have an identified responsible person referred to as the "external contact person" who has agreed to provide information about the participant's location if needed during outpatient portion of the study. The site personnel must consider this identified responsible person a reliable contact person, and the contact person must have regular contact with the participant (defined at screening as direct contact no fewer than 3 times per week), and with the expectation that this frequency of contact would continue (either in person or via other contact method), throughout duration of the study, including the follow-up period) Exclusion Criteria: The main exclusion criteria include, but are not limited to the following: Has a primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment Meets criteria for moderate to severe substance use disorder within past 6 months prior to screening (excluding those related to caffeine or nicotine) Has a known history of the following: (a) borderline personality disorder, anti-social personality disorder, or bipolar disorder (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease, or another form of dementia, or any chronic organic disease of the central nervous system (c) intellectual disability of a severity that would impact ability to participate in the study Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse Is or was under involuntary commitment for the acute episode, because the participant is considered a danger to themselves or others Has a history of treatment resistance exhibited by any of the following: (a) no or minimal response to at least 2 periods of treatment lasting 6 weeks or longer, with antipsychotic agents at the maximally tolerated dose. Participants who have responded to antipsychotics only when paired with clozapine are considered treatment-resistant (b) history of electroconvulsive therapy (ECT) treatment for treatment-resistant schizophrenia within the past 6 months (c) past or current use of clozapine as single or adjunctive therapy for schizophrenia within the past 3 months Is currently participating in or has participated in another clinical study and received an experimental or investigational drug agent within 3 months prior to screening visit of this current study and has participated in no more than 2 studies in the past 2 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Pillar Clinical Research ( Site 1047)
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712-3873
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
479-367-2688
Facility Name
Woodland International Research Group, LLC ( Site 1002)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
501-221-8681
Facility Name
Woodland Research Northwest, LLC ( Site 1036)
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
479-927-3000
Facility Name
CITRIALS ( Site 1010)
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
866-478-8391
Facility Name
ProScience Research Group ( Site 1046)
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
608-772-7681
Facility Name
Collaborative Neuroscience Research, LLC ( Site 1041)
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
714-799-7799
Facility Name
Behavioral Research Specialists, LLC ( Site 1032)
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Completed
Facility Name
CITRIALS ( Site 1016)
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
866-478-8391
Facility Name
Artemis Institute for Clinical Research ( Site 1019)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Completed
Facility Name
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) ( Site 103
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
619-481-5252
Facility Name
Schuster Medical Research Institute ( Site 1023)
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
818-788-0746
Facility Name
Behavioral Clinical Research ( Site 1058)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-722-1981
Facility Name
Behavioral Clinical Research , Inc ( Site 1013)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Completed
Facility Name
Premier Clinical Research Institute ( Site 1049)
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-392-0279
Facility Name
Fort Lauderdale Behavioral Health Center ( Site 1028)
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Individual Site Status
Completed
Facility Name
Research Centers of America ( Fort Lauderdale ) ( Site 1065)
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-604-3900
Facility Name
Health Synergy Clinical Research ( Site 1051)
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
786-863-3325
Facility Name
Atlanta Center For Medical Research ( Site 1022)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-881-5800
Facility Name
iResearch Atlanta ( Site 1039)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-537-1281
Facility Name
Ascension Saint Elizabeth ( Site 1000)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
312-491-5498
Facility Name
Uptown Research Institute ( Site 1052)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
773-968-9868
Facility Name
Pillar Clinical Research, LLC ( Site 1038)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60641
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-396-4844 ext 201
Facility Name
Benchmark Research ( Site 1054)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
318-797-8988
Facility Name
CBH Health ( Site 1044)
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
301-251-4702
Facility Name
Massachusetts General Hospital ( Site 1035)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Completed
Facility Name
Arch Clinical Trials ( Site 1048)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-230-4326
Facility Name
Altea Research Institute ( Site 1012)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Completed
Facility Name
Hassman Research Institute Marlton Site ( Site 1040)
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
856-452-9901
Facility Name
Richmond Behavioral Associates ( Site 1064)
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
718-751-6750
Facility Name
New Hope Clinical Research ( Site 1050)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Completed
Facility Name
Midwest Clinical Research ( Site 1059)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
937-424-1050
Facility Name
Midwest Clinical Research Center ( Site 1033)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Completed
Facility Name
Neuro-Behavioral Clinical Research ( Site 1055)
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
330-493-1118
Facility Name
Community Clinical Research ( Site 1057)
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
512-779-6715
Facility Name
Pillar Clinical Research, LLC ( Site 1004)
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-396-4844
Facility Name
State Psychiatric Hospital "Sv. Ivan Rilski", Novi Iskar ( Site 3001)
City
Novi Iskar
State/Province
Sofia
ZIP/Postal Code
1282
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+35929917603
Facility Name
Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD ( Site 3002)
City
Burgas
ZIP/Postal Code
8001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+359888451225
Facility Name
State Psychiatric Hospital - Kardzhali ( Site 3005)
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3593612695
Facility Name
Mental Health Center - Ruse, EOOD ( Site 3003)
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+359887110991
Facility Name
Center for Mental Health Prof. Nikola Shipkovenski Ltd ( Site 3000)
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+359878556847
Facility Name
Mental Health Center - Veliko Tarnovo ( Site 3006)
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+359888778615
Facility Name
Klinika za psihijatriju Vrapce ( Site 4000)
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10090
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38513713286
Facility Name
Klinika za psihijatriju Vrapce ( Site 4001)
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10090
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
385993542406
Facility Name
Klinicki bolnicki centar Rijeka ( Site 4005)
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38551658878
Facility Name
Klinika za psihijatriju Sveti Ivan ( Site 4003)
City
Zagreb
State/Province
Zagrebacka Zupanija
ZIP/Postal Code
10090
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38513430020
Facility Name
Seishinkai Okehazama Hospital Fujita Kokoro Care Center ( Site 2011)
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1168
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-562-97-1361
Facility Name
Kohnodai Hospital, National Center for Global Health and Medicine ( Site 2005)
City
Ichikawa
State/Province
Chiba
ZIP/Postal Code
272-8516
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-47-372-3501
Facility Name
Wakato Hospital ( Site 2031)
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
808-0139
Country
Japan
Individual Site Status
Completed
Facility Name
Shiranui Hospital ( Site 2043)
City
Omuta
State/Province
Fukuoka
ZIP/Postal Code
8360004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
＋81-944-55-2000
Facility Name
Seimou Hospital ( Site 2004)
City
Tomioka
State/Province
Gunma
ZIP/Postal Code
3702455
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-274-62-3156
Facility Name
Soushu Hospital ( Site 2008)
City
Atsugi
State/Province
Kanagawa
ZIP/Postal Code
243-0201
Country
Japan
Individual Site Status
Completed
Facility Name
Tanzawa Hospital ( Site 2037)
City
Hadano
State/Province
Kanagawa
ZIP/Postal Code
259-1304
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81463882455
Facility Name
Kanagawa Psychiatric Center ( Site 2035)
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
233-0006
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81458220241
Facility Name
Komoro Kogen Hospital ( Site 2046)
City
Komoro
State/Province
Nagano
ZIP/Postal Code
384-8540
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-267-22-0870
Facility Name
National Hospital Organization Ryukyu Hospital ( Site 2019)
City
Kunigamigun
State/Province
Okinawa
ZIP/Postal Code
904-1201
Country
Japan
Individual Site Status
Completed
Facility Name
Amekudai Hospital ( Site 2020)
City
Naha
State/Province
Okinawa
ZIP/Postal Code
900-0005
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-98-868-2101
Facility Name
National Hospital Organization Hizen Psychiatric Medical Center ( Site 2017)
City
Kanzaki-gun
State/Province
Saga
ZIP/Postal Code
8420192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-952-52-3231
Facility Name
Rainbow and Sea Hospital ( Site 2016)
City
Karatsu
State/Province
Saga
ZIP/Postal Code
847-0031
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-955-77-0711
Facility Name
Ongata Hospital ( Site 2007)
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0153
Country
Japan
Individual Site Status
Completed
Facility Name
Nishigahara Hospital ( Site 2042)
City
Kita-ku
State/Province
Tokyo
ZIP/Postal Code
114-0024
Country
Japan
Individual Site Status
Completed
Facility Name
National Center of Neurology and Psychiatry ( Site 2023)
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-42-341-2711
Facility Name
Chiba University Hospital ( Site 2024)
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-43-222-7171
Facility Name
Inokuchi Noma Hospital ( Site 2030)
City
Fukuoka
ZIP/Postal Code
815-0074
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-92-551-5301
Facility Name
Kuramitsu Hospital ( Site 2014)
City
Fukuoka
ZIP/Postal Code
819-0037
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-92-811-1821
Facility Name
Yuge Hospital ( Site 2018)
City
Kumamoto
ZIP/Postal Code
861-8002
Country
Japan
Individual Site Status
Completed
Facility Name
Seijin Hospital ( Site 2026)
City
Tokyo
ZIP/Postal Code
121-8515
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-50-3734-5401
Facility Name
Narimasu Kosei Hospital ( Site 2006)
City
Tokyo
ZIP/Postal Code
175-0091
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3939-1191
Facility Name
Inje University Busan Paik Hospital ( Site 0604)
City
Busan
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82518906436
Facility Name
Kyungpook National University Hospital ( Site 0601)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82534205747
Facility Name
Seoul National University Hospital ( Site 0600)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Daugavpils Psihoneirologiska Slimnica ( Site 8005)
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Individual Site Status
Completed
Facility Name
Piejuras Slimnica Psihiatriska Klinika ( Site 8001)
City
Liepaja
ZIP/Postal Code
3401
Country
Latvia
Individual Site Status
Completed
Facility Name
Specjal. Psychiatryczny ZOZ w Lodzi, Szpital im. Babinskiego ( Site 0905)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
91-229
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48427155985
Facility Name
Klinika Psychiatryczna Wydzialu Nauki o Zdrowiu WUM ( Site 0900)
City
Pruszkow
State/Province
Mazowieckie
ZIP/Postal Code
05-802
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4822 739 13 02
Facility Name
Samodzielny Wojewódzki Zespół Publicznych Zakładów Psychiatrycznej Opieki Zdrowotnej w Warszawie ( S
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-665
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48504530526
Facility Name
Uniwersyteckie Centrum Kliniczne ( Site 0902)
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-211
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48 583492650
Facility Name
Centrum Medyczne HCP ( Site 0913)
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
61-485
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48604116632
Facility Name
Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0815)
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0040723671301
Facility Name
Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0816)
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0040731581100
Facility Name
Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0817)
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40721243869
Facility Name
Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0818)
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Institutul de Psihiatrie Socola ( Site 0810)
City
Iași
State/Province
Iasi
ZIP/Postal Code
700282
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0040745353727
Facility Name
Institutul de Psihiatrie Socola ( Site 0814)
City
Iași
State/Province
Iasi
ZIP/Postal Code
700282
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40744518195
Facility Name
Arkhangelsk Regional Psychiatric Clinical Hospital ( Site 6020)
City
Arkhangelsk
State/Province
Arkhangel Skaya Oblast
ZIP/Postal Code
163530
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SGHI Leningrad Region Psyconeurology Dispensary ( Site 6017)
City
Leningrad Region
State/Province
Leningradskaya Oblast
ZIP/Postal Code
188820
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Lipetsk Regional Psychoneurology Hospital ( Site 6021)
City
Lipetsk
State/Province
Lipetskaya Oblast
ZIP/Postal Code
399083
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Moscow Scientific Research Institute for Psychiatry ( Site 6013)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
107076
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Psychiatric Clinical Hospital 4 named after PB Gannushkin ( Site 6016)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
107076
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Psychiatric Clinical Hospital 4 named after PB Gannushkin-Psychiatric department 4 ( Site 6023)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
107076
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Central Moscow Regional Clinical Psychiatric Hospital ( Site 6018)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
127083
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Bekhterev Research Institute for Psychoneurology ( Site 6008)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6000)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6001)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6002)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Stavropol Region Psychiatric Hospital #2 ( Site 6005)
City
Stavropol
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357034
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Federal State Scientific Institution Research Institute of Mental Health ( Site 6014)
City
Tomsk
State/Province
Tomskaya Oblast
ZIP/Postal Code
634014
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Yaroslavl Regional Clinical Psychiatry Hospital ( Site 6022)
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150003
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Clinical Center Kragujevac ( Site 5100)
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38134505148
Facility Name
Clinical Center Kragujevac ( Site 5102)
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38134505148
Facility Name
Clinical Center Kragujevac ( Site 5106)
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38134505148
Facility Name
Special Hospital for Psychiatric Diseases Kovin ( Site 5108)
City
Kovin
State/Province
Vojvodina
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38113741166
Facility Name
Special Hospital for Psychiatric Diseases Kovin ( Site 5109)
City
Kovin
State/Province
Vojvodina
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38113741166
Facility Name
China Medical University Hospital ( Site 9006)
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Completed
Facility Name
National Taiwan University Hospital ( Site 9001)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886223123456
Facility Name
Taipei City Hospital, Songde Branch ( Site 9004)
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Completed
Facility Name
Taipei Veterans General Hospital ( Site 9000)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Completed
Facility Name
Chang Gung Memorial Hospital - Linkou Branch ( Site 9002)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
CNE Cherkasy reg. psychiatric hospital of Cherkasy regional council ( Site 7009)
City
Smila
State/Province
Cherkaska Oblast
ZIP/Postal Code
20708
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Dnepropetrovsk Regional Clinical Hospital Mechnikov-Regional Centre of Psychosomatic Disorders base
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Completed
Facility Name
CNE "Precarpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council"" (
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76014
Country
Ukraine
Individual Site Status
Suspended
Facility Name
CNE of Kharkiv Reg. Council Reg. Clinical Psychiatric Hospital Nub 3 ( Site 7012)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Institute of Neurology,Psychiatry and Narcology AMS Ukraine ( Site 7011)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Suspended
Facility Name
CNE. Kherson Regional Psychiatric Hospital ( Site 7004)
City
Kherson
State/Province
Khersonska Oblast
ZIP/Postal Code
73488
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kyiv City Psychoneurological Hospital 2 ( Site 7008)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
02192
Country
Ukraine
Individual Site Status
Completed
Facility Name
CNE Clinical Hospital PSYCHIATRY of executive body of Kyiv City Council -Kyiv City State Admin ( Sit
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
04080
Country
Ukraine
Individual Site Status
Suspended
Facility Name
MNE of KRC-Regional psychiatric and narcological medical association ( Site 7005)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
08631
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Reg. Psych. Hosp. n.a. O. Yuschenko, Dept #21, VNMU n.a. M.Pirogov ( Site 7001)
City
Vinnytsya
State/Province
Vinnytska Oblast
ZIP/Postal Code
21037
Country
Ukraine
Individual Site Status
Suspended

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

Efficacy and Safety of MK-8189 in Participants With an Acute Episode of Schizophrenia (MK-8189-008)

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