Clinical trial NCT03968159: Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adjunctive Treatment of Major Depressive Disorder
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-30
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients, aged 18 years and above
2. A clinical diagnosis of major depressive disorder (MDD)
3. Is being treated with one of the following SSRI or SNRI antidepressants:

   1. Citalopram
   2. Escitalopram
   3. Paroxetine
   4. Fluoxetine
   5. Sertraline
   6. Duloxetine
   7. Venlafaxine
   8. Desvenlafaxine
   9. Venlafaxine XR
4. Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
5. 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:

1. 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
2. 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
3. Has a known history or symptoms of long QT syndrome
4. 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).

Primary outcomes:
measure: Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score
timeFrame: Baseline, Week 5
Secondary outcomes:
measure: Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms
timeFrame: Baseline, 5 weeks
measure: Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score
timeFrame: Baseline, 5 weeks
measure: Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form
timeFrame: Baseline, 5 weeks
measure: Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score
timeFrame: Baseline, 5 weeks
measure: Change From Baseline to Week 1 in the HAMD-17 Total Score
timeFrame: Baseline, 1 week
measure: Treatment Responder and Treatment Remission Rates at Week 5
timeFrame: Baseline, 5 weeks
measure: Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score
timeFrame: Baseline, 5 weeks
measure: Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11)
timeFrame: Baseline, 5 weeks
measure: Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5
timeFrame: Baseline, 5 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
city: Garden Grove
country: United States
facility: CNS Network
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Cromwell
country: United States
facility: CT Clinical Research
state: Connecticut
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc.
state: Florida
city: Orlando
country: United States
facility: CNS Health Care (Orlando)
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Synexus Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Prairie Village
country: United States
facility: Collective Medical Research, LLC
state: Kansas
city: Monroe
country: United States
facility: Clinical Trials of America (Monroe, LA)
state: Louisiana
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates-Midwest Research Group
state: Missouri
city: Brooklyn
country: United States
facility: Integrative Clinical Trials
state: New York
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute (SPRI)
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Rochester
country: United States
facility: Finger Lake Clinical Research
state: New York
city: Hickory
country: United States
facility: Clinical Trial of America, LLC
state: North Carolina
city: Garfield Heights
country: United States
facility: Charak Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Franklin
country: United States
facility: Psychiatric Consultants, PC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions CNS Healthcare
state: Tennessee
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC
state: Tennessee
city: Dallas
country: United States
facility: Future Search Trials of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Waukesha
country: United States
facility: IPC Research
state: Wisconsin
city: Helsinki
country: Finland
facility: ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)
city: Kuopio
country: Finland
facility: Savon Psykiatripalvelu Oy
city: Oulu
country: Finland
facility: Oulu Mentalcare Oy
city: Pori
country: Finland
facility: Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori
city: Tampere
country: Finland
facility: Psykiatri- ja psykologikeskus Mentoria
city: Bełchatów
country: Poland
facility: Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
city: Bydgoszcz
country: Poland
facility: Przychodnia Śródmieście Sp. z o.o.
city: Gdańsk
country: Poland
facility: Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała
city: Leszno
country: Poland
facility: Nzop Mentis
city: Plewiska
country: Poland
facility: Neurologiczny NZOZ im. dr n. med. Hanki
city: Szczecin
country: Poland
facility: Zachodniopomorski Instytut Psychoterapii
city: Moscow
country: Russian Federation
facility: Mental Health Research Center, Department #6
city: Saint Petersburg
country: Russian Federation
facility: St. Nicholas the Wonder Worker Psychiatric Hospital
city: Saint Petersburg
country: Russian Federation
facility: Psychoneurological Dispensary # 5
city: Saint Petersburg
country: Russian Federation
facility: City Narcology Hospital
city: Samara
country: Russian Federation
facility: Samara Psychiatric Hospital
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital # 2 n.a. V.I. Razumovsky
city: Saratov
country: Russian Federation
facility: Regional Clinical Psychiatric Hospital of St. Sofia
city: Voronezh
country: Russian Federation
facility: LION-MED
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Clinic for psychiatry
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr Dragisa Misovic
city: Kovin
country: Serbia
facility: Special hospital for psychiatric diseases "Kovin"
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac , Clinic for Psychiatry
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Niš
country: Serbia
facility: Centre for Mental Health Protection, Clinical Center Nis
city: Toponica
country: Serbia
facility: Clinical Centre Nis, Clinic for Psychiatry Gornja
city: Košice
country: Slovakia
facility: EPAMED s r.o.
city: Liptovský Mikuláš
country: Slovakia
facility: Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
city: Svidník
country: Slovakia
facility: Centrum Zdravia R.B.K., s.r.o.
city: Cape Town
country: South Africa
facility: Cape Trial Centre
city: Cape Town
country: South Africa
facility: Dr DG Dennis Incorporated Knighton Surgery
city: Durbanville
country: South Africa
facility: Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
city: Pretoria
country: South Africa
facility: Dr GP Bosch Clinical Research
city: Dnipro
country: Ukraine
facility: Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution "Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov
city: Kharkiv
country: Ukraine
facility: Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron"
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway"
city: Odesa
country: Ukraine
facility: Odesa Regional Medical Centre of Mental Health
city: Stepanivka
country: Ukraine
facility: Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region
city: Ternopil'
country: Ukraine
facility: 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
city: Vinnytsia
country: Ukraine
facility: 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
city: Vinnytsia
country: Ukraine
facility: 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
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research - Blackpool
city: Liverpool
country: United Kingdom
facility: MAC Clinical Research Ltd - Liverpool
city: Manchester
country: United Kingdom
facility: MAC Clinical Research - Manchester
Study officials:
References: