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

March 31, 2022 updated by: ACADIA Pharmaceuticals Inc.

A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

235

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Helsinki, Finland, 00100
        • ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)
      • Kuopio, Finland, 70110
        • Savon Psykiatripalvelu Oy
      • Oulu, Finland, 90100
        • Oulu Mentalcare Oy
      • Pori, Finland, 28130
        • Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori
      • Tampere, Finland, 33200
        • Psykiatri- ja psykologikeskus Mentoria
      • Belchatow, Poland, 97-400
        • Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
      • Bydgoszcz, Poland, 85-080
        • Przychodnia Srodmiescie Sp. z o.o.
      • Gdańsk, Poland, 80-438
        • Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała
      • Leszno, Poland, 64-100
        • Nzop Mentis
      • Szczecin, Poland, 70-480
        • Zachodniopomorski Instytut Psychoterapii
      • Moscow, Russian Federation, 115522
        • Mental Health Research Center, Department #6
      • Saint Petersburg, Russian Federation, 190121
        • St. Nicholas the Wonder Worker Psychiatric Hospital
      • Saint Petersburg, Russian Federation, 199004
        • City Narcology Hospital
      • Samara, Russian Federation, 443016
        • Samara Psychiatric Hospital
      • Saratov, Russian Federation, 410028
        • Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky
      • Saratov, Russian Federation, 410060
        • Regional Clinical Psychiatric Hospital of St. Sofia
      • St. Petersburg, Russian Federation, 195176
        • Psychoneurological Dispensary # 5
      • Voronezh, Russian Federation, 394052
        • LION-MED
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia, Clinic for Psychiatry
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Dr Dragisa Misovic
      • Gornja Toponica, Serbia, 18202
        • Clinical Centre Nis, Clinic for Psychiatry
      • Kovin, Serbia, 26220
        • Special hospital for psychiatric diseases "Kovin
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac , Clinic for Psychiatry
      • Nis, Serbia, 18000
        • Centre for Mental Health Protecton, Clinical Center Nis
      • Kosice, Slovakia, 04017
        • EPAMED s r.o.
      • Liptovsky Mikulas, Slovakia, 03123
        • Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
      • Svidnik, Slovakia, 50474
        • Centrum Zdravia R.B.K., s.r.o.
      • Durbanville,, South Africa, 7550
        • Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
      • Dnipro, Ukraine, 49005
        • Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov
      • Kharkiv, Ukraine, 61091
        • Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron"
      • Kyiv, Ukraine, 01030
        • Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway"
      • Stepanivka, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region,
      • Ternopil, Ukraine, 46027
        • 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
      • Vinnytsya, Ukraine, 21005
        • 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
      • Blackpool, United Kingdom, FY2 0JH
        • MAC Clinical Research- Blackpool
      • Liverpool, United Kingdom, L34 1BH
        • MAC Clinical Research Ltd.-Liverpool
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research- Manchester
    • California
      • Garden Grove, California, United States, 90806
        • CNS Network
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists
      • Irvine, California, United States, 92614
        • Irvine Clinical Research
      • Lemon Grove, California, United States, 91945
        • Synergy San Diego
      • Oakland, California, United States, 94607
        • Pacific Research Partners, LLC
      • Orange, California, United States, 92868
        • NRC Research Institute
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • MCB Clinical Research Centers, LLC
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville
      • Maitland, Florida, United States, 32751
        • Meridien Research
      • Miami, Florida, United States, 33174
        • Florida Research Center, Inc.
      • Orlando, Florida, United States, 32801
        • CNS Health Care (Orlando)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
      • Atlanta, Georgia, United States, 30328
        • Synexus Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
      • Libertyville, Illinois, United States, 60048
        • Capstone Clinical Research
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Collective Medical Research, LLC
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Adams Clinical
    • New York
      • Brooklyn, New York, United States, 11229
        • Integrative Clinical Trials
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Institute (SPRI)
      • New York, New York, United States, 10128
        • The Medical Research Network, LLC
      • New York, New York, United States, 10029
        • Department of Psychiatry, Icahn School of Medicine at Mount Sinai
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
    • Ohio
      • Garfield Heights, Ohio, United States, 44125
        • Charak Clinical Research Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon) Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 26464
        • Coastal Carolina Research Center
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Strategies of Memphis, LLC
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions CNS Healthcare
    • Texas
      • Dallas, Texas, United States, 75231
        • Future Search Trials of Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • Wichita Falls, Texas, United States, 76309
        • Grayline Research Center
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • IPC Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug - pimavanserin
Pimavanserin 34 mg tablets
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-emergent Adverse Events (TEAEs)
Time Frame: 52 weeks
Number of patients with treatment emergent AEs
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2019

Primary Completion (Actual)

February 22, 2021

Study Completion (Actual)

February 22, 2021

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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