Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
NCT ID: NCT04000009
Last Updated: 2022-04-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
235 participants
INTERVENTIONAL
2019-06-06
2021-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Drug - pimavanserin
Pimavanserin 34 mg tablets
Pimavanserin
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
Interventions
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Pimavanserin
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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CNS Network
Garden Grove, California, United States
Behavioral Research Specialists
Glendale, 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
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
Adams Clinical
Watertown, Massachusetts, United States
Integrative Clinical Trials
Brooklyn, New York, United States
Social Psychiatry Research Institute (SPRI)
Brooklyn, New York, 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
Finger Lakes Clinical Research
Rochester, New York, 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
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
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
Clinical Centre Nis, Clinic for Psychiatry
Gornja Toponica, , 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 Protecton, Clinical Center Nis
Niš, , 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
Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
Durbanville, , 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
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
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
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003252-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACP-103-055
Identifier Type: -
Identifier Source: org_study_id
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