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An Active-Controlled Early Phase Study of MK-8189 in Adults With Schizophrenia (MK-8189-005)

Primary Purpose

Schizophrenia, Acute Episode

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MK-8189
Risperidone
Placebo matching MK-8189
Placebo matching 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, Acute Episode focused on measuring Schizophrenia, acute episode, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to 50 years of age at Screening
  • Male
  • Female not of reproductive potential (e.g., postmenopausal or has had a hysterectomy), or agrees to practice abstinence or use acceptable contraception
  • Meets the diagnostic criteria for schizophrenia according to the DSM-5 criteria, or has a past diagnosis of schizophrenia with the onset of the first episode being >=1 year prior to study entry, and has illness duration of <=20 years
  • Is confirmed to be experiencing an acute episode of schizophrenia
  • Minimum PANSS score >= 80 at Screening
  • Has a score of >=4 in 3 or more of the following items (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution) in the positive subscale of the PANSS at Screening
  • Has a CGI-S score >= 4 at Screening
  • Is able to taper off psychotropic medications without significant destabilization or increased suicidality
  • Has responded positively to an antipsychotic medication other than clozapine in a prior psychotic episode
  • Has an identified responsible external contact person who has regular contact (no less than once per week) with the participant

Exclusion Criteria:

  • Is currently under involuntary commitment because he/she is considered a danger to himself/herself or others
  • Is unwilling to remain hospitalized for the duration of trial treatment
  • Is currently participating in or has participated in an interventional clinical research study <=6 months prior to Screening, or has participated in more than one interventional clinical trial research study within 12 months prior to Screening
  • Is unwilling to allow audio/video taping of the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders (MINI) and/or PANSS interview at Screening and Baseline
  • Is currently being treated with and benefiting from medications with a moderate or strong inhibiting or inducing effect on Cytochrome P450 (CYP) 3A and/or CYP2C9 and/or sensitive substrates of CYP2B6
  • Has a history of malignancy <= 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Has a body mass index <18.5 or >40 kg/m˄2
  • Has a history of treatment-resistant schizophrenia
  • Has a prolactin laboratory value of >= 5 times the upper limit of normal at Screening
  • Has a known history or clinical evidence of clinically significant hepatic, cardiovascular, or renal disease, or of untreated narrow-angle glaucoma- Has ever been diagnosed with epilepsy or had any seizure disorder beyond one childhood febrile seizure
  • Has known serological evidence of human immunodeficiency virus (HIV) antibody
  • Has a history of neuroleptic malignant syndrome
  • Has a current diagnosis other than schizophrenia, or a comorbid diagnosis primarily responsible for current symptoms and functional impairment
  • Has a known history of borderline personality disorder, antisocial personality disorder, or bipolar disorder
  • Has a known history of traumatic brain injury, or Alzheimer's disease or another form of dementia
  • Currently meets DSM-5 criteria for substance abuse or alcohol use disorder
  • Is at imminent risk of self-harm or harm to others

Sites / Locations

  • Woodland International Research Group, LLC ( Site 0001)
  • Woodland Research Northwest, LLC ( Site 0014)
  • CITRIALS ( Site 0013)
  • Comprehensive Clinical Development ( Site 0049)
  • Collaborative Neuroscience Network, LLC ( Site 0057)
  • Behavioral Research Specialists, LLC ( Site 0006)
  • Synergy East ( Site 0003)
  • NRC Research Institute ( Site 0043)
  • CNRI - Los Angeles, LLC ( Site 0026)
  • Artemis Institute for Clinical Research ( Site 0027)
  • Schuster Medical Research Institute ( Site 0032)
  • Collaborative Neuroscience Network, LLC ( Site 0046)
  • Larkin Community Hospital Behavioral Health Services ( Site 0020)
  • Clinical Research Centers of America, LLC ( Site 0038)
  • Aspire Health Partners ( Site 0016)
  • Radiant Research - Atlanta ( Site 0008)
  • Atlanta Center For Medical Research ( Site 0056)
  • Alexian Center for Psychiatric Research ( Site 0015)
  • Lake Charles Clinical Trials, LLC ( Site 0040)
  • CBH Health, LLC ( Site 0022)
  • Precise Research Centers ( Site 0018)
  • Psych Care Consultants Research ( Site 0025)
  • St. Louis Clinical Trials, LLC ( Site 0012)
  • Altea Research Institute ( Site 0017)
  • Radiant Research -CliniLabs ( Site 0037)
  • Midwest Clinical Research Unit ( Site 0041)
  • InSite Clinical Research ( Site 0033)
  • Pillar Clinical Research, LLC ( Site 0004)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

MK-8189

Risperidone

Placebo

Arm Description

Participants receive MK-8189 (4 mg controlled release [CR] oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) once daily (QD) for 4 weeks. Over the initial 7 treatment days, MK-8189 is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is also titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, MK-8189 is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks.

Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is also titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks.

Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks.

Outcomes

Primary Outcome Measures

Least Squares Mean (LSM) Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
The LSM change from baseline at week 4 was assessed for PANSS total score. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and sum to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Further, reduced symptom severity over time is reflected by decreases in score.
Percentage of Participants Experiencing an Adverse Event (AE)
The percentage of participants experiencing an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event
The percentage of participants discontinuing study treatment due to an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Secondary Outcome Measures

Least Squares Mean (LSM) Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4
The LSM change from baseline at week 4 was assessed for CGI-S score. The CGI-S is a 7-point clinician-rated scale for assessing the global severity of the participant's illness. Possible CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill). Further, a decrease in CGI-S score indicates reduced severity of the participant's illness.

Full Information

First Posted
February 14, 2017
Last Updated
December 6, 2018
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03055338
Brief Title
An Active-Controlled Early Phase Study of MK-8189 in Adults With Schizophrenia (MK-8189-005)
Official Title
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Efficacy and Safety of MK-8189 Using Risperidone as an Active Control in Subjects Experiencing an Acute Episode of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
January 9, 2018 (Actual)
Study Completion Date
January 9, 2018 (Actual)

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
No

5. Study Description

Brief Summary
This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of MK-8189 compared with placebo, using Risperidone as an active control. The participants will be adult subjects experiencing an acute episode of schizophrenia, according to the criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5). This study will be up to 7 weeks in duration, with up to 7 site visits for each participant. The study will consist of a Screening/tapering period (up to one week long), a 4-week treatment period, and a 14-day follow-up period. The primary objective will be to assess symptoms of schizophrenia at 4 weeks, and to assess safety and tolerability during treatment and post-treatment follow-up. The secondary objective will be to assess the severity of schizophrenia at 4 weeks. The primary hypothesis is that MK-8189 is superior to placebo in reducing the overall symptoms of schizophrenia as assessed by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score after 4 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Acute Episode
Keywords
Schizophrenia, acute episode, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of three groups in parallel for the duration of the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A double-blind/masking technique will be used. MK-8189 and risperidone will be packaged identically relative to their respective matching placebo so that blinding/masking is maintained.
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MK-8189
Arm Type
Experimental
Arm Description
Participants receive MK-8189 (4 mg controlled release [CR] oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) once daily (QD) for 4 weeks. Over the initial 7 treatment days, MK-8189 is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is also titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, MK-8189 is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks.
Arm Title
Risperidone
Arm Type
Active Comparator
Arm Description
Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is also titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks.
Intervention Type
Drug
Intervention Name(s)
MK-8189
Intervention Description
Oral CR tablets (4 mg) administered QD at the following dose strengths: 4 mg (1 tablet); 8 mg (2 tablets); 12 mg (3 tablets)
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Oral capsules (2 mg) administered QD at the following dose strengths: 2 mg (1 capsule); 4 mg (2 capsules); 6 mg (3 capsules)
Intervention Type
Drug
Intervention Name(s)
Placebo matching MK-8189
Intervention Description
Oral placebo tablet(s) matching the MK-8189 tablet, administered QD.
Intervention Type
Drug
Intervention Name(s)
Placebo matching risperidone
Intervention Description
Oral placebo capsule(s) matching the risperidone capsule, administered QD.
Primary Outcome Measure Information:
Title
Least Squares Mean (LSM) Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Description
The LSM change from baseline at week 4 was assessed for PANSS total score. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and sum to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Further, reduced symptom severity over time is reflected by decreases in score.
Time Frame
Baseline and Week 4
Title
Percentage of Participants Experiencing an Adverse Event (AE)
Description
The percentage of participants experiencing an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time Frame
Up to 6 weeks
Title
Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event
Description
The percentage of participants discontinuing study treatment due to an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Least Squares Mean (LSM) Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4
Description
The LSM change from baseline at week 4 was assessed for CGI-S score. The CGI-S is a 7-point clinician-rated scale for assessing the global severity of the participant's illness. Possible CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill). Further, a decrease in CGI-S score indicates reduced severity of the participant's illness.
Time Frame
Baseline and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 50 years of age at Screening Male Female not of reproductive potential (e.g., postmenopausal or has had a hysterectomy), or agrees to practice abstinence or use acceptable contraception Meets the diagnostic criteria for schizophrenia according to the DSM-5 criteria, or has a past diagnosis of schizophrenia with the onset of the first episode being >=1 year prior to study entry, and has illness duration of <=20 years Is confirmed to be experiencing an acute episode of schizophrenia Minimum PANSS score >= 80 at Screening Has a score of >=4 in 3 or more of the following items (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution) in the positive subscale of the PANSS at Screening Has a CGI-S score >= 4 at Screening Is able to taper off psychotropic medications without significant destabilization or increased suicidality Has responded positively to an antipsychotic medication other than clozapine in a prior psychotic episode Has an identified responsible external contact person who has regular contact (no less than once per week) with the participant Exclusion Criteria: Is currently under involuntary commitment because he/she is considered a danger to himself/herself or others Is unwilling to remain hospitalized for the duration of trial treatment Is currently participating in or has participated in an interventional clinical research study <=6 months prior to Screening, or has participated in more than one interventional clinical trial research study within 12 months prior to Screening Is unwilling to allow audio/video taping of the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders (MINI) and/or PANSS interview at Screening and Baseline Is currently being treated with and benefiting from medications with a moderate or strong inhibiting or inducing effect on Cytochrome P450 (CYP) 3A and/or CYP2C9 and/or sensitive substrates of CYP2B6 Has a history of malignancy <= 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer Has a body mass index <18.5 or >40 kg/m˄2 Has a history of treatment-resistant schizophrenia Has a prolactin laboratory value of >= 5 times the upper limit of normal at Screening Has a known history or clinical evidence of clinically significant hepatic, cardiovascular, or renal disease, or of untreated narrow-angle glaucoma- Has ever been diagnosed with epilepsy or had any seizure disorder beyond one childhood febrile seizure Has known serological evidence of human immunodeficiency virus (HIV) antibody Has a history of neuroleptic malignant syndrome Has a current diagnosis other than schizophrenia, or a comorbid diagnosis primarily responsible for current symptoms and functional impairment Has a known history of borderline personality disorder, antisocial personality disorder, or bipolar disorder Has a known history of traumatic brain injury, or Alzheimer's disease or another form of dementia Currently meets DSM-5 criteria for substance abuse or alcohol use disorder Is at imminent risk of self-harm or harm to others
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
Woodland International Research Group, LLC ( Site 0001)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest, LLC ( Site 0014)
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
CITRIALS ( Site 0013)
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Comprehensive Clinical Development ( Site 0049)
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC ( Site 0057)
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Behavioral Research Specialists, LLC ( Site 0006)
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Synergy East ( Site 0003)
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
NRC Research Institute ( Site 0043)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
CNRI - Los Angeles, LLC ( Site 0026)
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Artemis Institute for Clinical Research ( Site 0027)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Schuster Medical Research Institute ( Site 0032)
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC ( Site 0046)
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Larkin Community Hospital Behavioral Health Services ( Site 0020)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Clinical Research Centers of America, LLC ( Site 0038)
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Aspire Health Partners ( Site 0016)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Radiant Research - Atlanta ( Site 0008)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Center For Medical Research ( Site 0056)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Alexian Center for Psychiatric Research ( Site 0015)
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Lake Charles Clinical Trials, LLC ( Site 0040)
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
CBH Health, LLC ( Site 0022)
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Precise Research Centers ( Site 0018)
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Psych Care Consultants Research ( Site 0025)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
St. Louis Clinical Trials, LLC ( Site 0012)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Altea Research Institute ( Site 0017)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Radiant Research -CliniLabs ( Site 0037)
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Midwest Clinical Research Unit ( Site 0041)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
InSite Clinical Research ( Site 0033)
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Pillar Clinical Research, LLC ( Site 0004)
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Active-Controlled Early Phase Study of MK-8189 in Adults With Schizophrenia (MK-8189-005)

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