- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03968159
Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment (ACP-103-054/059)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00100
- ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)
-
Kuopio, Finland, 70110
- Savon Psykiatripalvelu Oy
-
Oulu, Finland, 90100
- Oulu Mentalcare Oy
-
Pori, Finland, 28130
- Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori
-
Tampere, Finland, 33200
- Psykiatri- ja psykologikeskus Mentoria
-
-
-
-
-
Bełchatów, Poland, 97-400
- Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
-
Bydgoszcz, Poland, 85-080
- Przychodnia Srodmiescie Sp. z o.o.
-
Gdańsk, Poland, 80-438
- Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała
-
Leszno, Poland, 64-100
- Nzop Mentis
-
Plewiska, Poland, 62-064
- Neurologiczny NZOZ im. dr n. med. Hanki
-
Szczecin, Poland, 70-480
- Zachodniopomorski Instytut Psychoterapii
-
-
-
-
-
Moscow, Russian Federation, 115522
- Mental Health Research Center, Department #6
-
Saint Petersburg, Russian Federation, 190121
- St. Nicholas the Wonder Worker Psychiatric Hospital
-
Saint Petersburg, Russian Federation, 199004
- City Narcology Hospital
-
Saint Petersburg, Russian Federation, 195176
- Psychoneurological Dispensary # 5
-
Samara, Russian Federation, 443016
- Samara Psychiatric Hospital
-
Saratov, Russian Federation, 410060
- Regional Clinical Psychiatric Hospital of St. Sofia
-
Saratov, Russian Federation, 410028
- Saratov City Clinical Hospital # 2 n.a. V.I. Razumovsky
-
Voronezh, Russian Federation, 394052
- LION-MED
-
-
-
-
-
Belgrade, Serbia, 11000
- Clinical Center of Serbia, Clinic for Psychiatry
-
Belgrade, Serbia, 11000
- Clinical Hospital Center Dr Dragisa Misovic
-
Kovin, Serbia, 26220
- Special Hospital for Psychiatric Diseases "Kovin"
-
Kragujevac, Serbia, 34000
- Clinical Center Kragujevac
-
Kragujevac, Serbia, 34000
- Clinical Center Kragujevac , Clinic for Psychiatry
-
Niš, Serbia, 18000
- Centre for Mental Health Protection, Clinical Center Nis
-
Toponica, Serbia, 18202
- Clinical Centre Nis, Clinic for Psychiatry Gornja
-
-
-
-
-
Košice, Slovakia, 040 17
- EPAMED s r.o.
-
Liptovský Mikuláš, Slovakia, 031 23
- Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
-
Svidník, Slovakia, 089 01
- Centrum Zdravia R.B.K., s.r.o.
-
-
-
-
-
Cape Town, South Africa, 7530
- Cape Trial Centre
-
Cape Town, South Africa, 7708
- Dr DG Dennis Incorporated Knighton Surgery
-
Durbanville, South Africa, 7550
- Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
-
Pretoria, South Africa, 0081
- Dr GP Bosch Clinical Research
-
-
-
-
-
Dnipro, Ukraine, 49005
- Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution "Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov
-
Kharkiv, Ukraine, 61091
- Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron"
-
Kyiv, Ukraine, 01030
- Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway"
-
Odesa, Ukraine, 65006
- Odesa Regional Medical Centre of Mental Health
-
Stepanivka, Ukraine, 73488
- Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region
-
Ternopil', Ukraine, 46027
- 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
-
Vinnytsia, Ukraine, 21005
- 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, 21005
- 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
-
-
-
-
-
Blackpool, United Kingdom, FY2 0JH
- MAC Clinical Research - Blackpool
-
Liverpool, United Kingdom, L34 1BH
- MAC Clinical Research Ltd - Liverpool
-
Manchester, United Kingdom, M13 9NQ
- MAC Clinical Research - Manchester
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham (UAB)
-
-
California
-
Garden Grove, California, United States, 92845
- CNS Network
-
Glendale, California, United States, 91206
- Behavioral Research Specialists
-
Imperial, California, United States, 92251
- Sun Valley Research Center
-
Irvine, California, United States, 92614
- Irvine Clinical Research
-
Lemon Grove, California, United States, 91945
- Synergy San Diego
-
Oakland, California, United States, 94607
- Pacific Research Partners, LLC
-
Orange, California, United States, 92868
- NRC Research Institute
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80910
- MCB Clinical Research Centers, LLC
-
Denver, Colorado, United States, 80209
- Mountain View Clinical Research, Inc.
-
-
Connecticut
-
Cromwell, Connecticut, United States, 06416
- CT Clinical Research
-
-
Florida
-
Jacksonville, Florida, United States, 32256
- Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville
-
Maitland, Florida, United States, 32751
- Meridien Research
-
Miami, Florida, United States, 33174
- Florida Research Center, Inc.
-
Orlando, Florida, United States, 32801
- CNS Health Care (Orlando)
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University School of Medicine
-
Atlanta, Georgia, United States, 30328
- Synexus Clinical Research
-
-
Illinois
-
Chicago, Illinois, United States, 60640
- Great Lakes Clinical Trials
-
Libertyville, Illinois, United States, 60048
- Capstone Clinical Research
-
-
Kansas
-
Prairie Village, Kansas, United States, 66208
- Collective Medical Research, LLC
-
-
Louisiana
-
Monroe, Louisiana, United States, 71201
- Clinical Trials of America (Monroe, LA)
-
-
Massachusetts
-
Watertown, Massachusetts, United States, 02472
- Adams Clinical
-
-
Missouri
-
Saint Charles, Missouri, United States, 63304
- St. Charles Psychiatric Associates-Midwest Research Group
-
-
New York
-
Brooklyn, New York, United States, 11229
- Integrative Clinical Trials
-
Brooklyn, New York, United States, 11235
- Social Psychiatry Research Institute (SPRI)
-
New York, New York, United States, 10128
- The Medical Research Network, LLC
-
New York, New York, United States, 10029
- Mount Sinai Hospital
-
Rochester, New York, United States, 14618
- Finger Lake Clinical Research
-
-
North Carolina
-
Hickory, North Carolina, United States, 28601
- Clinical Trial of America, LLC
-
-
Ohio
-
Garfield Heights, Ohio, United States, 44125
- Charak Clinical Research Center
-
-
Oregon
-
Portland, Oregon, United States, 97210
- Summit Research Network (Oregon) Inc.
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
South Carolina
-
Mount Pleasant, South Carolina, United States, 26464
- Coastal Carolina Research Center
-
-
Tennessee
-
Franklin, Tennessee, United States, 37067
- Psychiatric Consultants, PC
-
Memphis, Tennessee, United States, 38119
- Research Strategies of Memphis, LLC
-
Memphis, Tennessee, United States, 38119
- Clinical Neuroscience Solutions CNS Healthcare
-
-
Texas
-
Dallas, Texas, United States, 75231
- Future Search Trials of Dallas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
San Antonio, Texas, United States, 78229
- Clinical Trials of Texas, Inc.
-
Wichita Falls, Texas, United States, 76309
- Grayline Research Center
-
-
Wisconsin
-
Waukesha, Wisconsin, United States, 53188
- IPC Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo tablets
|
Placebo (2×placebo tablets [size- and color-matched to pimavanserin]) administered orally as a single dose once daily
|
Experimental: Drug - pimavanserin
Pimavanserin 34 mg tablets
|
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score
Time Frame: Baseline, Week 5
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms
Time Frame: Baseline, 5 weeks
|
The CGI-S rates the severity of a subject's depression over the past 7 days and the score ranges from 1 to 7. Higher CGI-S scores denote more severe depression.
|
Baseline, 5 weeks
|
Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score
Time Frame: Baseline, 5 weeks
|
The SDS is a 3-item subject-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility.
Subjects rate each item using an 11-point scale ranging from 0 (not at all) to 10 (extremely).
Higher scores denote greater disability.
|
Baseline, 5 weeks
|
Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form
Time Frame: Baseline, 5 weeks
|
The CSFQ-14 is a 14-item version of the CSFQ.
This is a patient-facing questionnaire, with a male version and a female version.
The total score ranging from 14 to 70 will be calculated as the sum of the scores for all 14 items.
Higher total scores denote better sexual functioning.
|
Baseline, 5 weeks
|
Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score
Time Frame: Baseline, 5 weeks
|
The KSS is a scale that measures the subject's drowsiness and is frequently used in studies measuring subjective sleepiness.
Scoring is based on a 9-point verbally anchored scale going from "1 = extremely alert" to "9 = very sleepy, great effort to keep awake, fighting sleep".
Higher scores denote more drowsiness.
|
Baseline, 5 weeks
|
Change From Baseline to Week 1 in the HAMD-17 Total Score
Time Frame: Baseline, 1 week
|
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, 1 week
|
Treatment Responder and Treatment Remission Rates at Week 5
Time Frame: Baseline, 5 weeks
|
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.
Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more.
Treatment remission is defined as a HAMD-17 total score ≤7.
|
Baseline, 5 weeks
|
Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score
Time Frame: Baseline, 5 weeks
|
The Anxiety/Somatization factor of the HAMD-17 includes 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight.
The HAMD-17 Anxiety/Somatization factor score ranging from 0 to 18 will be calculated as the sum of the scores for the 6 items.
Higher scores denote more severe anxiety/somatization condition.
|
Baseline, 5 weeks
|
Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11)
Time Frame: Baseline, 5 weeks
|
The BIS-11 is a questionnaire designed to assess the personality/behavioral construct of impulsiveness.
It is composed of 30 items describing common impulsive or non-impulsive (reverse scored items: 1, 7, 8, 9, 10, 12, 13, 15, 20, 29, and 30) behaviors and preferences.
Items are scored on the following 4-point scale: Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4.
For reverse scored items, a response of 1 is recoded to 4; 2 is recoded to 3; 3 is recoded to 2; and 4 is recoded to 1.
The BIS-11 score ranging from 30 to 120 will be calculated as the sum of the scores for all 30 items.
Higher scores denote more impulsiveness.
|
Baseline, 5 weeks
|
Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5
Time Frame: Baseline, 5 weeks
|
The CGI-I rates the change in a subject's depression over the past 7 days relative to the subject's symptoms at Baseline and the score ranges from 1 to 7. Higher CGI-I scores denote less improvement in Depression.
|
Baseline, 5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Pimavanserin
Other Study ID Numbers
- ACP-103-054/059
- 2018-003251-37 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adjunctive Treatment of Major Depressive Disorder
-
ACADIA Pharmaceuticals Inc.CompletedAdjunctive Treatment of Major Depressive DisorderUnited States
-
Clexio Biosciences Ltd.CompletedAdjunctive Treatment of Major Depressive DisorderUnited States, Puerto Rico
-
ACADIA Pharmaceuticals Inc.TerminatedAdjunctive Treatment of Major Depressive DisorderUnited States, Serbia, Finland, Poland, Russian Federation, Slovakia, South Africa, Ukraine, United Kingdom
-
Wayne Goodman MDActive, not recruitingTreatment Resistant Major Depressive DisorderUnited States
-
Baylor College of MedicineIcahn School of Medicine at Mount SinaiCompletedMajor Depressive Disorder (MDD) | Treatment Resistant Depression (TRD)United States
-
Helse Stavanger HFWithdrawnMajor Depressive Disorder | Treatment Resistant Depression | Major Depressive Episode
-
Centre for Addiction and Mental HealthUniversity Health Network, TorontoRecruiting
-
University of MinnesotaCompleted
-
Eli Lilly and CompanyCompletedMajor Depressive DisorderUnited States, Canada
-
Mclean HospitalRecruitingMajor Depressive DisorderUnited States
Clinical Trials on Pimavanserin
-
ACADIA Pharmaceuticals Inc.CompletedDementia-related PsychosisUnited States, Spain, Poland, Ukraine, Chile, Czechia, United Kingdom, Bulgaria, France, Germany, Italy, Serbia, Slovakia
-
ACADIA Pharmaceuticals Inc.TerminatedAgitation and Aggression in Alzheimer's DiseaseUnited States, France, Spain, Chile, United Kingdom
-
ACADIA Pharmaceuticals Inc.Approved for marketingParkinson's Disease Psychosis
-
ACADIA Pharmaceuticals Inc.CompletedParkinson's Disease PsychosisSpain, United States, Belgium, Austria, Serbia, Poland, Portugal, Italy, Sweden
-
VA Office of Research and DevelopmentACADIA Pharmaceuticals Inc.RecruitingInsomnia | Post-traumatic Stress DisorderUnited States
-
ACADIA Pharmaceuticals Inc.CompletedParkinson's Disease PsychosisUnited States
-
ACADIA Pharmaceuticals Inc.CompletedParkinson's Disease PsychosisUnited States, Austria, France, Canada, Belgium, Russian Federation, Serbia, Ukraine, Poland, Portugal, Italy, India, United Kingdom, Sweden
-
ACADIA Pharmaceuticals Inc.CompletedParkinson's Disease PsychosisUnited States, Canada
-
Ohio State UniversityACADIA Pharmaceuticals Inc.Not yet recruiting
-
Bjorn H. EbdrupRigshospitalet, Denmark; ACADIA Pharmaceuticals Inc.; GCP unit, Copenhagen University...WithdrawnSchizophrenia | Psychosis