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Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Primary Purpose

Adjunctive Treatment of Major Depressive Disorder

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
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. Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059
  2. May benefit from longer term therapy with open-label pimavanserin treatment
  3. If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

  1. Is determined to be inappropriate for the study
  2. Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program

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

  • CNS Network
  • Behavioral Research Specialists
  • Irvine Clinical Research
  • Synergy San Diego
  • Pacific Research Partners, LLC
  • NRC Research Institute
  • MCB Clinical Research centers, LLC
  • 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
  • Adams Clinical
  • Integrative Clinical Trials
  • Social Psychiatry Research Institute (SPRI)
  • Department of Psychiatry, Icahn School of Medicine at Mount Sinai
  • The Medical Research Network, LLC
  • Finger Lakes Clinical Research
  • Charak Clinical Research Center
  • Summit Research Network (Oregon) Inc.
  • University of Pennsylvania
  • Coastal Carolina Research Center
  • 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
  • Zachodniopomorski Instytut Psychoterapii
  • Mental Health Research Center, Department #6
  • St. Nicholas the Wonder Worker Psychiatric Hospital
  • City Narcology Hospital
  • Samara Psychiatric Hospital
  • Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky
  • Regional Clinical Psychiatric Hospital of St. Sofia
  • Psychoneurological Dispensary # 5
  • LION-MED
  • Clinical Center of Serbia, Clinic for psychiatry
  • Clinical Hospital Center Dr Dragisa Misovic
  • Clinical Centre Nis, Clinic for Psychiatry
  • Special hospital for psychiatric diseases "Kovin
  • Clinical Center Kragujevac , Clinic for Psychiatry
  • Clinical Center Kragujevac
  • Centre for Mental Health Protecton, Clinical Center Nis
  • EPAMED s r.o.
  • Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
  • Centrum Zdravia R.B.K., s.r.o.
  • Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
  • 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"
  • 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
  • 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 Type

Experimental

Arm Label

Drug - pimavanserin

Arm Description

Pimavanserin 34 mg tablets

Outcomes

Primary Outcome Measures

Treatment-emergent Adverse Events (TEAEs)
Number of patients with treatment emergent AEs

Secondary Outcome Measures

Full Information

First Posted
June 25, 2019
Last Updated
March 31, 2022
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04000009
Brief Title
Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Official Title
A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated for business reasons and not due to safety concerns.
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (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 assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug - pimavanserin
Arm Type
Experimental
Arm Description
Pimavanserin 34 mg 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
Primary Outcome Measure Information:
Title
Treatment-emergent Adverse Events (TEAEs)
Description
Number of patients with treatment emergent AEs
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059 May benefit from longer term therapy with open-label pimavanserin treatment If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception Exclusion Criteria: Is determined to be inappropriate for the study Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program 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
CNS Network
City
Garden Grove
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Behavioral Research Specialists
City
Glendale
State/Province
California
ZIP/Postal Code
91206
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
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
Adams Clinical
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
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
Department of Psychiatry, Icahn School of Medicine at Mount Sinai
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 Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
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
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
Belchatow
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
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
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
Psychoneurological Dispensary # 5
City
St. Petersburg
ZIP/Postal Code
195176
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
Clinical Centre Nis, Clinic for Psychiatry
City
Gornja Toponica
ZIP/Postal Code
18202
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 Protecton, Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
EPAMED s r.o.
City
Kosice
ZIP/Postal Code
04017
Country
Slovakia
Facility Name
Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
City
Liptovsky Mikulas
ZIP/Postal Code
03123
Country
Slovakia
Facility Name
Centrum Zdravia R.B.K., s.r.o.
City
Svidnik
ZIP/Postal Code
50474
Country
Slovakia
Facility Name
Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
City
Durbanville,
ZIP/Postal Code
7550
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
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
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
Vinnytsya
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

Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

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