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Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Primary Purpose

Adjunctive Treatment of Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
Placebo
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adjunctive Treatment of Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients, aged 18 years and above
  2. A clinical diagnosis of major depressive disorder (MDD)

  3. Is being treated with one of the following SSRI or SNRI antidepressants:

    1. Citalopram
    2. Escitalopram
    3. Paroxetine
    4. Fluoxetine
    5. Sertraline
    6. Duloxetine
    7. Venlafaxine
    8. Desvenlafaxine
    9. Venlafaxine XR
  4. Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
  5. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

  1. Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
  2. Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
  3. Has a known history or symptoms of long QT syndrome
  4. Is determined to be inappropriate for the study for any reason

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Sites / Locations

  • University of Alabama at Birmingham (UAB)
  • CNS Network
  • Behavioral Research Specialists
  • Sun Valley Research Center
  • Irvine Clinical Research
  • Synergy San Diego
  • Pacific Research Partners, LLC
  • NRC Research Institute
  • MCB Clinical Research Centers, LLC
  • Mountain View Clinical Research, Inc.
  • CT Clinical Research
  • Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville
  • Meridien Research
  • Florida Research Center, Inc.
  • CNS Health Care (Orlando)
  • Emory University School of Medicine
  • Synexus Clinical Research
  • Great Lakes Clinical Trials
  • Capstone Clinical Research
  • Collective Medical Research, LLC
  • Clinical Trials of America (Monroe, LA)
  • Adams Clinical
  • St. Charles Psychiatric Associates-Midwest Research Group
  • Integrative Clinical Trials
  • Social Psychiatry Research Institute (SPRI)
  • Mount Sinai Hospital
  • The Medical Research Network, LLC
  • Finger Lake Clinical Research
  • Clinical Trial of America, LLC
  • Charak Clinical Research Center
  • Summit Research Network (Oregon) Inc.
  • University Of Pennsylvania
  • Coastal Carolina Research Center
  • Psychiatric Consultants, PC
  • Clinical Neuroscience Solutions CNS Healthcare
  • Research Strategies of Memphis, LLC
  • Future Search Trials of Dallas
  • Baylor College of Medicine
  • Clinical Trials of Texas, Inc.
  • Grayline Research Center
  • IPC Research
  • ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)
  • Savon Psykiatripalvelu Oy
  • Oulu Mentalcare Oy
  • Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori
  • Psykiatri- ja psykologikeskus Mentoria
  • Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
  • Przychodnia Śródmieście Sp. z o.o.
  • Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała
  • Nzop Mentis
  • Neurologiczny NZOZ im. dr n. med. Hanki
  • Zachodniopomorski Instytut Psychoterapii
  • Mental Health Research Center, Department #6
  • St. Nicholas the Wonder Worker Psychiatric Hospital
  • Psychoneurological Dispensary # 5
  • City Narcology Hospital
  • Samara Psychiatric Hospital
  • Saratov City Clinical Hospital # 2 n.a. V.I. Razumovsky
  • Regional Clinical Psychiatric Hospital of St. Sofia
  • LION-MED
  • Clinical Center of Serbia, Clinic for psychiatry
  • Clinical Hospital Center Dr Dragisa Misovic
  • Special hospital for psychiatric diseases "Kovin"
  • Clinical Center Kragujevac , Clinic for Psychiatry
  • Clinical Center Kragujevac
  • Centre for Mental Health Protection, Clinical Center Nis
  • Clinical Centre Nis, Clinic for Psychiatry Gornja
  • EPAMED s r.o.
  • Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
  • Centrum Zdravia R.B.K., s.r.o.
  • Cape Trial Centre
  • Dr DG Dennis Incorporated Knighton Surgery
  • Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
  • Dr GP Bosch Clinical Research
  • Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution "Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov
  • Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron"
  • Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway"
  • Odesa Regional Medical Centre of Mental Health
  • Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region
  • Ternopil Regional Communal Clinical Psychoneurological Hospital, psychiatric department # 2 (men), psychiatric department # 6 (women), Ternopil State Medical University n.a. I.Y. Gorbachevskyy, Chair of Psychiatry, Narcology and Medical Psychology
  • Communal Institution "Vinnytsia Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Department #7 (male), Department #10 (female),Vinnytsia National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeuti
  • Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #14, Female Department #15, Vinnytsya National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeutic
  • MAC Clinical Research - Blackpool
  • MAC Clinical Research Ltd - Liverpool
  • MAC Clinical Research - Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug - pimavanserin

Placebo

Arm Description

Pimavanserin 34 mg tablets

Placebo tablets

Outcomes

Primary Outcome Measures

Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.

Secondary Outcome Measures

Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms
The CGI-S rates the severity of a subject's depression over the past 7 days and the score ranges from 1 to 7. Higher CGI-S scores denote more severe depression.
Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score
The SDS is a 3-item subject-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. Subjects rate each item using an 11-point scale ranging from 0 (not at all) to 10 (extremely). Higher scores denote greater disability.
Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form
The CSFQ-14 is a 14-item version of the CSFQ. This is a patient-facing questionnaire, with a male version and a female version. The total score ranging from 14 to 70 will be calculated as the sum of the scores for all 14 items. Higher total scores denote better sexual functioning.
Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score
The KSS is a scale that measures the subject's drowsiness and is frequently used in studies measuring subjective sleepiness. Scoring is based on a 9-point verbally anchored scale going from "1 = extremely alert" to "9 = very sleepy, great effort to keep awake, fighting sleep". Higher scores denote more drowsiness.
Change From Baseline to Week 1 in the HAMD-17 Total Score
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.
Treatment Responder and Treatment Remission Rates at Week 5
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more. Treatment remission is defined as a HAMD-17 total score ≤7.
Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score
The Anxiety/Somatization factor of the HAMD-17 includes 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. The HAMD-17 Anxiety/Somatization factor score ranging from 0 to 18 will be calculated as the sum of the scores for the 6 items. Higher scores denote more severe anxiety/somatization condition.
Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11)
The BIS-11 is a questionnaire designed to assess the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (reverse scored items: 1, 7, 8, 9, 10, 12, 13, 15, 20, 29, and 30) behaviors and preferences. Items are scored on the following 4-point scale: Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4. For reverse scored items, a response of 1 is recoded to 4; 2 is recoded to 3; 3 is recoded to 2; and 4 is recoded to 1. The BIS-11 score ranging from 30 to 120 will be calculated as the sum of the scores for all 30 items. Higher scores denote more impulsiveness.
Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5
The CGI-I rates the change in a subject's depression over the past 7 days relative to the subject's symptoms at Baseline and the score ranges from 1 to 7. Higher CGI-I scores denote less improvement in Depression.

Full Information

First Posted
May 13, 2019
Last Updated
October 19, 2021
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03968159
Brief Title
Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Official Title
Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment (ACP-103-054/059)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.

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
To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy
Detailed Description
Two separate studies, idential in design, were planned and initiated under 2 protocol IDs and NCTs, i.e. study ACP-103-54 (NCT03999918) and ACP-103-059 (NCT03968159). In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled. This entry now includes the combined data of studies ACP-103-054 and ACP-103-059.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjunctive Treatment of Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug - pimavanserin
Arm Type
Experimental
Arm Description
Pimavanserin 34 mg tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Intervention Description
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (2×placebo tablets [size- and color-matched to pimavanserin]) administered orally as a single dose once daily
Primary Outcome Measure Information:
Title
Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score
Description
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.
Time Frame
Baseline, Week 5
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms
Description
The CGI-S rates the severity of a subject's depression over the past 7 days and the score ranges from 1 to 7. Higher CGI-S scores denote more severe depression.
Time Frame
Baseline, 5 weeks
Title
Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score
Description
The SDS is a 3-item subject-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. Subjects rate each item using an 11-point scale ranging from 0 (not at all) to 10 (extremely). Higher scores denote greater disability.
Time Frame
Baseline, 5 weeks
Title
Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form
Description
The CSFQ-14 is a 14-item version of the CSFQ. This is a patient-facing questionnaire, with a male version and a female version. The total score ranging from 14 to 70 will be calculated as the sum of the scores for all 14 items. Higher total scores denote better sexual functioning.
Time Frame
Baseline, 5 weeks
Title
Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score
Description
The KSS is a scale that measures the subject's drowsiness and is frequently used in studies measuring subjective sleepiness. Scoring is based on a 9-point verbally anchored scale going from "1 = extremely alert" to "9 = very sleepy, great effort to keep awake, fighting sleep". Higher scores denote more drowsiness.
Time Frame
Baseline, 5 weeks
Title
Change From Baseline to Week 1 in the HAMD-17 Total Score
Description
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.
Time Frame
Baseline, 1 week
Title
Treatment Responder and Treatment Remission Rates at Week 5
Description
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more. Treatment remission is defined as a HAMD-17 total score ≤7.
Time Frame
Baseline, 5 weeks
Title
Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score
Description
The Anxiety/Somatization factor of the HAMD-17 includes 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. The HAMD-17 Anxiety/Somatization factor score ranging from 0 to 18 will be calculated as the sum of the scores for the 6 items. Higher scores denote more severe anxiety/somatization condition.
Time Frame
Baseline, 5 weeks
Title
Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11)
Description
The BIS-11 is a questionnaire designed to assess the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (reverse scored items: 1, 7, 8, 9, 10, 12, 13, 15, 20, 29, and 30) behaviors and preferences. Items are scored on the following 4-point scale: Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4. For reverse scored items, a response of 1 is recoded to 4; 2 is recoded to 3; 3 is recoded to 2; and 4 is recoded to 1. The BIS-11 score ranging from 30 to 120 will be calculated as the sum of the scores for all 30 items. Higher scores denote more impulsiveness.
Time Frame
Baseline, 5 weeks
Title
Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5
Description
The CGI-I rates the change in a subject's depression over the past 7 days relative to the subject's symptoms at Baseline and the score ranges from 1 to 7. Higher CGI-I scores denote less improvement in Depression.
Time Frame
Baseline, 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, aged 18 years and above A clinical diagnosis of major depressive disorder (MDD) Is being treated with one of the following SSRI or SNRI antidepressants: Citalopram Escitalopram Paroxetine Fluoxetine Sertraline Duloxetine Venlafaxine Desvenlafaxine Venlafaxine XR Inadequate response to SSRI/SNRI antidepressant treatment is confirmed If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception Exclusion Criteria: Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program Has a known history or symptoms of long QT syndrome Is determined to be inappropriate for the study for any reason Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
CNS Network
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Behavioral Research Specialists
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Irvine Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Pacific Research Partners, LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
MCB Clinical Research Centers, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Mountain View Clinical Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
CT Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Meridien Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Florida Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
CNS Health Care (Orlando)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Synexus Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Collective Medical Research, LLC
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Clinical Trials of America (Monroe, LA)
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Adams Clinical
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
St. Charles Psychiatric Associates-Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Integrative Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Social Psychiatry Research Institute (SPRI)
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Finger Lake Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Clinical Trial of America, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Charak Clinical Research Center
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
Summit Research Network (Oregon) Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
26464
Country
United States
Facility Name
Psychiatric Consultants, PC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Clinical Neuroscience Solutions CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Research Strategies of Memphis, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Future Search Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
IPC Research
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Savon Psykiatripalvelu Oy
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Oulu Mentalcare Oy
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori
City
Pori
ZIP/Postal Code
28130
Country
Finland
Facility Name
Psykiatri- ja psykologikeskus Mentoria
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
City
Bełchatów
ZIP/Postal Code
97-400
Country
Poland
Facility Name
Przychodnia Śródmieście Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Facility Name
Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała
City
Gdańsk
ZIP/Postal Code
80-438
Country
Poland
Facility Name
Nzop Mentis
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
Neurologiczny NZOZ im. dr n. med. Hanki
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
Zachodniopomorski Instytut Psychoterapii
City
Szczecin
ZIP/Postal Code
70-480
Country
Poland
Facility Name
Mental Health Research Center, Department #6
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
St. Nicholas the Wonder Worker Psychiatric Hospital
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Psychoneurological Dispensary # 5
City
Saint Petersburg
ZIP/Postal Code
195176
Country
Russian Federation
Facility Name
City Narcology Hospital
City
Saint Petersburg
ZIP/Postal Code
199004
Country
Russian Federation
Facility Name
Samara Psychiatric Hospital
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
Saratov City Clinical Hospital # 2 n.a. V.I. Razumovsky
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Regional Clinical Psychiatric Hospital of St. Sofia
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
LION-MED
City
Voronezh
ZIP/Postal Code
394052
Country
Russian Federation
Facility Name
Clinical Center of Serbia, Clinic for psychiatry
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Dr Dragisa Misovic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Special hospital for psychiatric diseases "Kovin"
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Facility Name
Clinical Center Kragujevac , Clinic for Psychiatry
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Centre for Mental Health Protection, Clinical Center Nis
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinical Centre Nis, Clinic for Psychiatry Gornja
City
Toponica
ZIP/Postal Code
18202
Country
Serbia
Facility Name
EPAMED s r.o.
City
Košice
ZIP/Postal Code
040 17
Country
Slovakia
Facility Name
Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
City
Liptovský Mikuláš
ZIP/Postal Code
031 23
Country
Slovakia
Facility Name
Centrum Zdravia R.B.K., s.r.o.
City
Svidník
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Cape Trial Centre
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Dr DG Dennis Incorporated Knighton Surgery
City
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
City
Durbanville
ZIP/Postal Code
7550
Country
South Africa
Facility Name
Dr GP Bosch Clinical Research
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution "Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron"
City
Kharkiv
ZIP/Postal Code
61091
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway"
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Odesa Regional Medical Centre of Mental Health
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region
City
Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Ternopil Regional Communal Clinical Psychoneurological Hospital, psychiatric department # 2 (men), psychiatric department # 6 (women), Ternopil State Medical University n.a. I.Y. Gorbachevskyy, Chair of Psychiatry, Narcology and Medical Psychology
City
Ternopil'
ZIP/Postal Code
46027
Country
Ukraine
Facility Name
Communal Institution "Vinnytsia Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Department #7 (male), Department #10 (female),Vinnytsia National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeuti
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #14, Female Department #15, Vinnytsya National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeutic
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
MAC Clinical Research - Blackpool
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd - Liverpool
City
Liverpool
ZIP/Postal Code
L34 1BH
Country
United Kingdom
Facility Name
MAC Clinical Research - Manchester
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

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