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

NCT03968159 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: ACP-103-054/0592018-003251-37
• Study Type: interventional
• Target: 298
• Locations: 9 countries
• Sites: 85

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

Conditions

Adjunctive Treatment of Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 5

Secondary Outcomes (9)

• Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms

  Baseline, 5 weeks

• Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score

  Baseline, 5 weeks

• Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form

  Baseline, 5 weeks

• Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score

  Baseline, 5 weeks

• Change From Baseline to Week 1 in the HAMD-17 Total Score

  Baseline, 1 week

Study Arms (2)

Drug - pimavanserin

EXPERIMENTAL

Pimavanserin 34 mg tablets

Drug: Pimavanserin

Placebo

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo

Interventions

Pimavanserin DRUG

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

Drug - pimavanserin

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (85)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233, United States

Location

CNS Network

Garden Grove, California, 92845, United States

Location

Behavioral Research Specialists

Glendale, California, 91206, United States

Location

Sun Valley Research Center

Imperial, California, 92251, 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

Mountain View Clinical Research, Inc.

Denver, Colorado, 80209, United States

Location

CT Clinical Research

Cromwell, Connecticut, 06416, 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

Clinical Trials of America (Monroe, LA)

Monroe, Louisiana, 71201, United States

Location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

St. Charles Psychiatric Associates-Midwest Research Group

Saint Charles, Missouri, 63304, 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

Mount Sinai Hospital

New York, New York, 10029, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Finger Lake Clinical Research

Rochester, New York, 14618, United States

Location

Clinical Trial of America, LLC

Hickory, North Carolina, 28601, 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

Psychiatric Consultants, PC

Franklin, Tennessee, 37067, 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

Neurologiczny NZOZ im. dr n. med. Hanki

Plewiska, 62-064, 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

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 Protection, Clinical Center Nis

Niš, 18000, Serbia

Location

Clinical Centre Nis, Clinic for Psychiatry Gornja

Toponica, 18202, Serbia

Location

EPAMED s r.o.

Košice, 040 17, Slovakia

Location

Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie

Liptovský Mikuláš, 031 23, Slovakia

Location

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

Svidník, 089 01, Slovakia

Location

Cape Trial Centre

Cape Town, 7530, South Africa

Location

Dr DG Dennis Incorporated Knighton Surgery

Cape Town, 7708, South Africa

Location

Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center

Durbanville, 7550, South Africa

Location

Dr GP Bosch Clinical Research

Pretoria, 0081, 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

Odesa Regional Medical Centre of Mental Health

Odesa, 65006, 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

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, 21005, 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

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 this trial with the identically designed trial ACP-103-054, 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.

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 30, 2019
• Study Start: April 25, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 29, 2020
• Last Updated: November 17, 2021
• Results First Posted: November 17, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (8); SE (7); SL (3); US (41); PL (6); ZA (4); FI (5); GB (3); UA (8)