Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
- Conditions
- Adjunctive Treatment of Major Depressive Disorder
- Interventions
- Registration Number
- NCT04000009
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 235
- 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
- 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
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug - pimavanserin Pimavanserin Pimavanserin 34 mg tablets
- Primary Outcome Measures
Name Time Method Treatment-emergent Adverse Events (TEAEs) 52 weeks Number of patients with treatment emergent AEs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Centrum Zdravia R.B.K., s.r.o.
๐ธ๐ฐSvidnik, Slovakia
Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
๐ธ๐ฐLiptovsky Mikulas, Slovakia
EPAMED s r.o.
๐ธ๐ฐKosice, Slovakia
Psykiatri- ja psykologikeskus Mentoria
๐ซ๐ฎTampere, Finland
Synergy San Diego
๐บ๐ธLemon Grove, California, United States
Nzop Mentis
๐ต๐ฑLeszno, Poland
CNS Network
๐บ๐ธGarden Grove, California, United States
Irvine Clinical Research
๐บ๐ธIrvine, California, United States
ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)
๐ซ๐ฎHelsinki, Finland
Collective Medical Research, LLC
๐บ๐ธPrairie Village, Kansas, United States
Oulu Mentalcare Oy
๐ซ๐ฎOulu, Finland
Satakunnan Psykiatripalvelu Oy at Mehilรคinen Pori
๐ซ๐ฎPori, Finland
Samara Psychiatric Hospital
๐ท๐บSamara, Russian Federation
Clinical Center Kragujevac
๐ท๐ธKragujevac, Serbia
Centre for Mental Health Protecton, Clinical Center Nis
๐ท๐ธNis, Serbia
Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region,
๐บ๐ฆStepanivka, Ukraine
Pacific Research Partners, LLC
๐บ๐ธOakland, California, United States
MCB Clinical Research centers, LLC
๐บ๐ธColorado Springs, Colorado, United States
Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville
๐บ๐ธJacksonville, Florida, United States
NRC Research Institute
๐บ๐ธOrange, California, United States
Meridien Research
๐บ๐ธMaitland, Florida, United States
Capstone Clinical Research
๐บ๐ธLibertyville, Illinois, United States
Adams Clinical
๐บ๐ธWatertown, Massachusetts, United States
Social Psychiatry Research Institute (SPRI)
๐บ๐ธBrooklyn, New York, United States
Integrative Clinical Trials
๐บ๐ธBrooklyn, New York, United States
Department of Psychiatry, Icahn School of Medicine at Mount Sinai
๐บ๐ธNew York, New York, United States
The Medical Research Network, LLC
๐บ๐ธNew York, New York, United States
Finger Lakes Clinical Research
๐บ๐ธRochester, New York, United States
Charak Clinical Research Center
๐บ๐ธGarfield Heights, Ohio, United States
Coastal Carolina Research Center
๐บ๐ธMount Pleasant, South Carolina, United States
Clinical Neuroscience Solutions CNS Healthcare
๐บ๐ธMemphis, Tennessee, United States
Research Strategies of Memphis, LLC
๐บ๐ธMemphis, Tennessee, United States
Grayline Research Center
๐บ๐ธWichita Falls, Texas, United States
Savon Psykiatripalvelu Oy
๐ซ๐ฎKuopio, Finland
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
๐ต๐ฑBelchatow, Poland
Zachodniopomorski Instytut Psychoterapii
๐ต๐ฑSzczecin, Poland
Mental Health Research Center, Department #6
๐ท๐บMoscow, Russian Federation
St. Nicholas the Wonder Worker Psychiatric Hospital
๐ท๐บSaint Petersburg, Russian Federation
City Narcology Hospital
๐ท๐บSaint Petersburg, Russian Federation
Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky
๐ท๐บSaratov, Russian Federation
Regional Clinical Psychiatric Hospital of St. Sofia
๐ท๐บSaratov, Russian Federation
Clinical Center of Serbia, Clinic for psychiatry
๐ท๐ธBelgrade, Serbia
Psychoneurological Dispensary # 5
๐ท๐บSt. Petersburg, Russian Federation
LION-MED
๐ท๐บVoronezh, Russian Federation
Clinical Hospital Center Dr Dragisa Misovic
๐ท๐ธBelgrade, Serbia
Clinical Center Kragujevac , Clinic for Psychiatry
๐ท๐ธKragujevac, Serbia
Clinical Centre Nis, Clinic for Psychiatry
๐ท๐ธGornja Toponica, Serbia
Special hospital for psychiatric diseases "Kovin
๐ท๐ธKovin, Serbia
Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
๐ฟ๐ฆDurbanville,, South Africa
MAC Clinical Research Ltd.-Liverpool
๐ฌ๐งLiverpool, United Kingdom
MAC Clinical Research- Manchester
๐ฌ๐งManchester, United Kingdom
MAC Clinical Research- Blackpool
๐ฌ๐งBlackpool, United Kingdom
Indywidualna Specijalistyczna Praktyka Lekarska Wiesลaw Jerzy Cubaลa
๐ต๐ฑGdaลsk, Poland
Przychodnia ลrรณdmieลcie Sp. Z o.o.
๐ต๐ฑBydgoszcz, Poland
Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron"
๐บ๐ฆKharkiv, Ukraine
Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov
๐บ๐ฆDnipro, Ukraine
Kyiv Railway Clinical Hospital โ 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway"
๐บ๐ฆKyiv, 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
๐บ๐ฆTernopil, 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
๐บ๐ฆVinnytsya, Ukraine
Future Search Trials of Dallas
๐บ๐ธDallas, Texas, United States
Florida Research Center, Inc.
๐บ๐ธMiami, Florida, United States
CNS Health Care (Orlando)
๐บ๐ธOrlando, Florida, United States
Emory University School of Medicine
๐บ๐ธAtlanta, Georgia, United States
Synexus Clinical Research
๐บ๐ธAtlanta, Georgia, United States
Great Lakes Clinical Trials
๐บ๐ธChicago, Illinois, United States
Summit Research Network (Oregon) Inc.
๐บ๐ธPortland, Oregon, United States
University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
Clinical Trials of Texas, Inc.
๐บ๐ธSan Antonio, Texas, United States
Baylor College of Medicine
๐บ๐ธHouston, Texas, United States
IPC Research
๐บ๐ธWaukesha, Wisconsin, United States
Behavioral Research Specialists
๐บ๐ธGlendale, California, United States