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

Adjunctive Treatment of Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04000009
• Other study ID #: ACP-103-055
• Secondary ID: 2018-003252-20
• Status: Terminated
• Phase: Phase 3
• Start date: June 6, 2019
• Est. completion date: February 22, 2021

Study information

• Verified date: March 2022
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 235
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adjunctive Treatment of Major Depressive Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
Finland	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
Poland	Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski	Belchatow
Poland	Przychodnia Sródmiescie Sp. Z o.o.	Bydgoszcz
Poland	Indywidualna Specijalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala	Gdansk
Poland	Nzop Mentis	Leszno
Poland	Zachodniopomorski Instytut Psychoterapii	Szczecin
Russian Federation	Mental Health Research Center, Department #6	Moscow
Russian Federation	City Narcology Hospital	Saint Petersburg
Russian Federation	St. Nicholas the Wonder Worker Psychiatric Hospital	Saint Petersburg
Russian Federation	Samara Psychiatric Hospital	Samara
Russian Federation	Regional Clinical Psychiatric Hospital of St. Sofia	Saratov
Russian Federation	Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky	Saratov
Russian Federation	Psychoneurological Dispensary # 5	St. Petersburg
Russian Federation	LION-MED	Voronezh
Serbia	Clinical Center of Serbia, Clinic for psychiatry	Belgrade
Serbia	Clinical Hospital Center Dr Dragisa Misovic	Belgrade
Serbia	Clinical Centre Nis, Clinic for Psychiatry	Gornja Toponica
Serbia	Special hospital for psychiatric diseases "Kovin	Kovin
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Center Kragujevac , Clinic for Psychiatry	Kragujevac
Serbia	Centre for Mental Health Protecton, Clinical Center Nis	Nis
Slovakia	EPAMED s r.o.	Kosice
Slovakia	Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie	Liptovsky Mikulas
Slovakia	Centrum Zdravia R.B.K., s.r.o.	Svidnik
South Africa	Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center	Durbanville,
Ukraine	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	Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region,	Stepanivka
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	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	Vinnytsya
United Kingdom	MAC Clinical Research- Blackpool	Blackpool
United Kingdom	MAC Clinical Research Ltd.-Liverpool	Liverpool
United Kingdom	MAC Clinical Research- Manchester	Manchester
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Synexus Clinical Research	Atlanta	Georgia
United States	Integrative Clinical Trials	Brooklyn	New York
United States	Social Psychiatry Research Institute (SPRI)	Brooklyn	New York
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	MCB Clinical Research centers, LLC	Colorado Springs	Colorado
United States	Future Search Trials of Dallas	Dallas	Texas
United States	CNS Network	Garden Grove	California
United States	Charak Clinical Research Center	Garfield Heights	Ohio
United States	Behavioral Research Specialists	Glendale	California
United States	Baylor College of Medicine	Houston	Texas
United States	Irvine Clinical Research	Irvine	California
United States	Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville	Jacksonville	Florida
United States	Synergy San Diego	Lemon Grove	California
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Meridien Research	Maitland	Florida
United States	Clinical Neuroscience Solutions CNS Healthcare	Memphis	Tennessee
United States	Research Strategies of Memphis, LLC	Memphis	Tennessee
United States	Florida Research Center, Inc.	Miami	Florida
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Department of Psychiatry, Icahn School of Medicine at Mount Sinai	New York	New York
United States	The Medical Research Network, LLC	New York	New York
United States	Pacific Research Partners, LLC	Oakland	California
United States	NRC Research Institute	Orange	California
United States	CNS Health Care (Orlando)	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Collective Medical Research, LLC	Prairie Village	Kansas
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Adams Clinical	Watertown	Massachusetts
United States	IPC Research	Waukesha	Wisconsin
United States	Grayline Research Center	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Finland,  Poland,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent Adverse Events (TEAEs)	Number of patients with treatment emergent AEs	52 weeks