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

NCT04000009 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: ACP-103-0552018-003252-20
• Study Type: interventional
• Target: 235
• Locations: 9 countries
• Sites: 71

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.

Conditions

Adjunctive Treatment of Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent Adverse Events (TEAEs)

  Number of patients with treatment emergent AEs

  52 weeks

Study Arms (1)

Drug - pimavanserin

EXPERIMENTAL

Pimavanserin 34 mg tablets

Drug: Pimavanserin

Interventions

Pimavanserin DRUG

Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily

Drug - pimavanserin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (71)

CNS Network

Garden Grove, California, 90806, United States

Location

Behavioral Research Specialists

Glendale, California, 91206, United States

Location

Irvine Clinical Research

Irvine, California, 92614, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Pacific Research Partners, LLC

Oakland, California, 94607, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

MCB Clinical Research centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville

Jacksonville, Florida, 32256, United States

Location

Meridien Research

Maitland, Florida, 32751, United States

Location

Florida Research Center, Inc.

Miami, Florida, 33174, United States

Location

CNS Health Care (Orlando)

Orlando, Florida, 32801, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Synexus Clinical Research

Atlanta, Georgia, 30328, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Collective Medical Research, LLC

Prairie Village, Kansas, 66208, United States

Location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

Location

Social Psychiatry Research Institute (SPRI)

Brooklyn, New York, 11235, United States

Location

Department of Psychiatry, Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Charak Clinical Research Center

Garfield Heights, Ohio, 44125, United States

Location

Summit Research Network (Oregon) Inc.

Portland, Oregon, 97210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 26464, United States

Location

Clinical Neuroscience Solutions CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Research Strategies of Memphis, LLC

Memphis, Tennessee, 38119, United States

Location

Future Search Trials of Dallas

Dallas, Texas, 75231, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

IPC Research

Waukesha, Wisconsin, 53188, United States

Location

ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)

Helsinki, 00100, Finland

Location

Savon Psykiatripalvelu Oy

Kuopio, 70110, Finland

Location

Oulu Mentalcare Oy

Oulu, 90100, Finland

Location

Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori

Pori, 28130, Finland

Location

Psykiatri- ja psykologikeskus Mentoria

Tampere, 33200, Finland

Location

Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski

Bełchatów, 97-400, Poland

Location

Przychodnia Śródmieście Sp. Z o.o.

Bydgoszcz, 85-080, Poland

Location

Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała

Gdansk, 80-438, Poland

Location

Nzop Mentis

Leszno, 64-100, Poland

Location

Zachodniopomorski Instytut Psychoterapii

Szczecin, 70-480, Poland

Location

Mental Health Research Center, Department #6

Moscow, 115522, Russia

Location

St. Nicholas the Wonder Worker Psychiatric Hospital

Saint Petersburg, 190121, Russia

Location

Psychoneurological Dispensary # 5

Saint Petersburg, 195176, Russia

Location

City Narcology Hospital

Saint Petersburg, 199004, Russia

Location

Samara Psychiatric Hospital

Samara, 443016, Russia

Location

Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky

Saratov, 410028, Russia

Location

Regional Clinical Psychiatric Hospital of St. Sofia

Saratov, 410060, Russia

Location

LION-MED

Voronezh, 394052, Russia

Location

Clinical Center of Serbia, Clinic for psychiatry

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Dr Dragisa Misovic

Belgrade, 11000, Serbia

Location

Clinical Centre Nis, Clinic for Psychiatry

Gornja Toponica, 18202, Serbia

Location

Special hospital for psychiatric diseases "Kovin

Kovin, 26220, Serbia

Location

Clinical Center Kragujevac , Clinic for Psychiatry

Kragujevac, 34000, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Centre for Mental Health Protecton, Clinical Center Nis

Niš, 18000, Serbia

Location

EPAMED s r.o.

Košice, 04017, Slovakia

Location

Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie

Liptovský Mikuláš, 03123, Slovakia

Location

Centrum Zdravia R.B.K., s.r.o.

Svidník, 50474, Slovakia

Location

Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center

Durbanville, 7550, South Africa

Location

Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov

Dnipro, 49005, Ukraine

Location

Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron"

Kharkiv, 61091, Ukraine

Location

Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway"

Kyiv, 01030, Ukraine

Location

Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region,

Stepanovka, 73488, Ukraine

Location

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

Ternopil, 46027, Ukraine

Location

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

Vinnytsia, 21005, Ukraine

Location

MAC Clinical Research- Blackpool

Blackpool, FY2 0JH, United Kingdom

Location

MAC Clinical Research Ltd.-Liverpool

Liverpool, L34 1BH, United Kingdom

Location

MAC Clinical Research- Manchester

Manchester, M13 9NQ, United Kingdom

Location

MeSH Terms

Interventions

pimavanserin

Limitations and Caveats

This study was terminated early by the Sponsor for business reasons due to the COVID-19 pandemic; there were no safety concerns contributing to study termination. Patients were discontinued from the study and completed safety follow-up procedures.

Results Point of Contact

• Title: Sr. Dir. Medical Information and Medical Communications
• Organization: Acadia Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

858-261

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: June 6, 2019
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: April 5, 2022
• Results First Posted: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (8); PL (5); SL (3); US (33); UA (6); GB (3); SE (7); ZA (1); FI (5)