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

NCT ID: NCT03968159

Last Updated: 2021-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-25
• Study Completion Date: 2020-05-29

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.

Conditions

Adjunctive Treatment of Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Drug - pimavanserin

Pimavanserin 34 mg tablets

Group Type: EXPERIMENTAL

Pimavanserin

Intervention Type: DRUG

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

Placebo

Placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (2×placebo tablets \[size- and color-matched to pimavanserin\]) administered orally as a single dose once daily

Interventions

Pimavanserin

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

Intervention Type: DRUG

Placebo

Placebo (2×placebo tablets \[size- and color-matched to pimavanserin\]) administered orally as a single dose once daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACADIA Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

CNS Network

Garden Grove, California, United States

Behavioral Research Specialists

Glendale, California, United States

Sun Valley Research Center

Imperial, California, United States

Irvine Clinical Research

Irvine, California, United States

Synergy San Diego

Lemon Grove, California, United States

Pacific Research Partners, LLC

Oakland, California, United States

NRC Research Institute

Orange, California, United States

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, United States

Mountain View Clinical Research, Inc.

Denver, Colorado, United States

CT Clinical Research

Cromwell, Connecticut, United States

Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville

Jacksonville, Florida, United States

Meridien Research

Maitland, Florida, United States

Florida Research Center, Inc.

Miami, Florida, United States

CNS Health Care (Orlando)

Orlando, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Synexus Clinical Research

Atlanta, Georgia, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Capstone Clinical Research

Libertyville, Illinois, United States

Collective Medical Research, LLC

Prairie Village, Kansas, United States

Clinical Trials of America (Monroe, LA)

Monroe, Louisiana, United States

Adams Clinical

Watertown, Massachusetts, United States

St. Charles Psychiatric Associates-Midwest Research Group

Saint Charles, Missouri, United States

Integrative Clinical Trials

Brooklyn, New York, United States

Social Psychiatry Research Institute (SPRI)

Brooklyn, New York, United States

Mount Sinai Hospital

New York, New York, United States

The Medical Research Network, LLC

New York, New York, United States

Finger Lake Clinical Research

Rochester, New York, United States

Clinical Trial of America, LLC

Hickory, North Carolina, United States

Charak Clinical Research Center

Garfield Heights, Ohio, United States

Summit Research Network (Oregon) Inc.

Portland, Oregon, United States

University Of Pennsylvania

Philadelphia, Pennsylvania, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Psychiatric Consultants, PC

Franklin, Tennessee, United States

Clinical Neuroscience Solutions CNS Healthcare

Memphis, Tennessee, United States

Research Strategies of Memphis, LLC

Memphis, Tennessee, United States

Future Search Trials of Dallas

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Grayline Research Center

Wichita Falls, Texas, United States

IPC Research

Waukesha, Wisconsin, United States

ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)

Helsinki, , Finland

Savon Psykiatripalvelu Oy

Kuopio, , Finland

Oulu Mentalcare Oy

Oulu, , Finland

Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori

Pori, , Finland

Psykiatri- ja psykologikeskus Mentoria

Tampere, , Finland

Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski

Bełchatów, , Poland

Przychodnia Śródmieście Sp. z o.o.

Bydgoszcz, , Poland

Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała

Gdansk, , Poland

Nzop Mentis

Leszno, , Poland

Neurologiczny NZOZ im. dr n. med. Hanki

Plewiska, , Poland

Zachodniopomorski Instytut Psychoterapii

Szczecin, , Poland

Mental Health Research Center, Department #6

Moscow, , Russia

St. Nicholas the Wonder Worker Psychiatric Hospital

Saint Petersburg, , Russia

Psychoneurological Dispensary # 5

Saint Petersburg, , Russia

City Narcology Hospital

Saint Petersburg, , Russia

Samara Psychiatric Hospital

Samara, , Russia

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

Saratov, , Russia

Regional Clinical Psychiatric Hospital of St. Sofia

Saratov, , Russia

LION-MED

Voronezh, , Russia

Clinical Center of Serbia, Clinic for psychiatry

Belgrade, , Serbia

Clinical Hospital Center Dr Dragisa Misovic

Belgrade, , Serbia

Special hospital for psychiatric diseases "Kovin"

Kovin, , Serbia

Clinical Center Kragujevac , Clinic for Psychiatry

Kragujevac, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Centre for Mental Health Protection, Clinical Center Nis

Niš, , Serbia

Clinical Centre Nis, Clinic for Psychiatry Gornja

Toponica, , Serbia

EPAMED s r.o.

Košice, , Slovakia

Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie

Liptovský Mikuláš, , Slovakia

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

Svidník, , Slovakia

Cape Trial Centre

Cape Town, , South Africa

Dr DG Dennis Incorporated Knighton Surgery

Cape Town, , South Africa

Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center

Durbanville, , South Africa

Dr GP Bosch Clinical Research

Pretoria, , South Africa

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

Dnipro, , Ukraine

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

Kharkiv, , Ukraine

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

Kyiv, , Ukraine

Odesa Regional Medical Centre of Mental Health

Odesa, , Ukraine

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

Stepanovka, , Ukraine

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, , Ukraine

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

Vinnytsia, , Ukraine

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, , Ukraine

MAC Clinical Research - Blackpool

Blackpool, , United Kingdom

MAC Clinical Research Ltd - Liverpool

Liverpool, , United Kingdom

MAC Clinical Research - Manchester

Manchester, , United Kingdom

Countries

United States; Finland; Poland; Russia; Serbia; Slovakia; South Africa; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol: Study ACP-103-059 protocol (NCT03968159)

View Document

Document Type: Study Protocol: Study ACP-103-054 protocol (NCT03999918)

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-003251-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACP-103-054/059

Identifier Type: -

Identifier Source: org_study_id

NCT03999918

Identifier Type: -

Identifier Source: nct_alias