Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
- Conditions
- Adjunctive Treatment of Major Depressive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT03968159
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 298
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug - pimavanserin Pimavanserin Pimavanserin 34 mg tablets Placebo Placebo Placebo tablets
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms 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.
Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score 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.
Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form 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.
Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score 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.
Change From Baseline to Week 1 in the HAMD-17 Total Score 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.
Treatment Responder and Treatment Remission Rates at Week 5 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.
Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score 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.
Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11) 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.
Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5 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.
Trial Locations
- Locations (85)
IPC Research
🇺🇸Waukesha, Wisconsin, United States
Collective Medical Research, LLC
🇺🇸Prairie Village, Kansas, United States
Clinical Neuroscience Solutions CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Clinical Trial of America, LLC
🇺🇸Hickory, North Carolina, United States
NRC Research Institute
🇺🇸Orange, California, United States
University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Future Search Trials of Dallas
🇺🇸Dallas, Texas, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)
🇫🇮Helsinki, Finland
Psychiatric Consultants, PC
🇺🇸Franklin, Tennessee, United States
Charak Clinical Research Center
🇺🇸Garfield Heights, Ohio, United States
Psychoneurological Dispensary # 5
🇷🇺Saint Petersburg, Russian Federation
MAC Clinical Research Ltd - Liverpool
🇬🇧Liverpool, United Kingdom
LION-MED
🇷🇺Voronezh, Russian Federation
Zachodniopomorski Instytut Psychoterapii
🇵🇱Szczecin, Poland
Clinical Hospital Center Dr Dragisa Misovic
🇷🇸Belgrade, Serbia
Mental Health Research Center, Department #6
🇷🇺Moscow, Russian Federation
EPAMED s r.o.
🇸🇰Košice, Slovakia
Saratov City Clinical Hospital # 2 n.a. V.I. Razumovsky
🇷🇺Saratov, Russian Federation
MAC Clinical Research - Manchester
🇬🇧Manchester, United Kingdom
Clinical Center of Serbia, Clinic for psychiatry
🇷🇸Belgrade, Serbia
Special hospital for psychiatric diseases "Kovin"
🇷🇸Kovin, Serbia
City Narcology Hospital
🇷🇺Saint Petersburg, Russian Federation
Dr GP Bosch Clinical Research
🇿🇦Pretoria, South Africa
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
🇸🇰Liptovský Mikuláš, Slovakia
Samara Psychiatric Hospital
🇷🇺Samara, Russian Federation
MAC Clinical Research - Blackpool
🇬🇧Blackpool, United Kingdom
Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
🇿🇦Durbanville, South Africa
Cape Trial Centre
🇿🇦Cape Town, South Africa
MCB Clinical Research Centers, LLC
🇺🇸Colorado Springs, Colorado, United States
Behavioral Research Specialists
🇺🇸Glendale, California, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
CNS Network
🇺🇸Garden Grove, 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
CT Clinical Research
🇺🇸Cromwell, Connecticut, United States
Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville
🇺🇸Jacksonville, Florida, United States
Synexus Clinical Research
🇺🇸Atlanta, Georgia, United States
Meridien Research
🇺🇸Maitland, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Clinical Trials of America (Monroe, LA)
🇺🇸Monroe, Louisiana, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
St. Charles Psychiatric Associates-Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Integrative Clinical Trials
🇺🇸Brooklyn, New York, United States
Social Psychiatry Research Institute (SPRI)
🇺🇸Brooklyn, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Finger Lake Clinical Research
🇺🇸Rochester, New York, United States
Research Strategies of Memphis, LLC
🇺🇸Memphis, Tennessee, United States
Savon Psykiatripalvelu Oy
🇫🇮Kuopio, Finland
Przychodnia Śródmieście Sp. z o.o.
🇵🇱Bydgoszcz, Poland
Nzop Mentis
🇵🇱Leszno, Poland
St. Nicholas the Wonder Worker Psychiatric Hospital
🇷🇺Saint Petersburg, Russian Federation
Regional Clinical Psychiatric Hospital of St. Sofia
🇷🇺Saratov, Russian Federation
Clinical Center Kragujevac , Clinic for Psychiatry
🇷🇸Kragujevac, Serbia
Dr DG Dennis Incorporated Knighton Surgery
🇿🇦Cape Town, South Africa
Mountain View Clinical Research, Inc.
🇺🇸Denver, Colorado, United States
Summit Research Network (Oregon) Inc.
🇺🇸Portland, Oregon, United States
Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
University of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
CNS Health Care (Orlando)
🇺🇸Orlando, Florida, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Odesa Regional Medical Centre of Mental Health
🇺🇦Odesa, Ukraine
Centre for Mental Health Protection, Clinical Center Nis
🇷🇸Niš, Serbia
Psykiatri- ja psykologikeskus Mentoria
🇫🇮Tampere, Finland
Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała
🇵🇱Gdańsk, Poland
Neurologiczny NZOZ im. dr n. med. Hanki
🇵🇱Plewiska, Poland
Centrum Zdravia R.B.K., s.r.o.
🇸🇰Svidník, Slovakia
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
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
🇵🇱Bełchatów, Poland
Oulu Mentalcare Oy
🇫🇮Oulu, Finland
Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori
🇫🇮Pori, Finland
Clinical Centre Nis, Clinic for Psychiatry Gornja
🇷🇸Toponica, Serbia
Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region
🇺🇦Stepanivka, Ukraine
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
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
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