Clinical trial NCT03018340: Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adjunctive Treatment of Major Depressive Disorder
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-12
Enrollment: 207
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 assess the efficacy of pimavanserin compared to placebo when given adjunctively to a selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an inadequate response to antidepressant therapy


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 as monotherapy:

   * Citalopram
   * Escitalopram
   * Paroxetine
   * Fluoxetine
   * Sertraline
   * Duloxetine
   * Venlafaxine
   * Desvenlafaxine
   * Venlafaxine XR
4. Has a history of inadequate response to antidepressant treatments

Exclusion Criteria:

1. Patient has a psychotic disorder other than MDD
2. Patient has current evidence of a serious and/or unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
3. Patient has a history or symptoms of long QT syndrome

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 the HAMD-17 Total Score
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
Secondary outcomes:
measure: Change From Baseline to Week 5 in the SDS Total Score
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
measure: Treatment Response and Remission Rates at the End of 5-week Treatment Period
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
measure: Change From Baseline to Week 5 in CGI-S Total Score
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
measure: CGI-I Score at Week 5
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
measure: Change From Baseline to Week 5 in SF-12 Score
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
measure: Change From Baseline to Week 5 in DAI-10 Score
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
measure: Change From Baseline to Week 5 in KSS Score
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
measure: Change From Baseline to Week 5 in MGH-SFI Score
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
measure: Change From Baseline to Week 5 in BIS-11 Score
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
measure: Change From Baseline to Week 5 in SIS Score
timeFrame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
city: Rogers
country: United States
facility: Woodland Research Northwest
state: Arkansas
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: National City
country: United States
facility: Synergy San Diego
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Temecula
country: United States
facility: Viking Clinical Research
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Jacksonville
country: United States
facility: CNS Health care (Jacksonville)
state: Florida
city: Maitland
country: United States
facility: Meridien Research
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: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Chicago
country: United States
facility: Alam Medical Research, INC
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Wichita
country: United States
facility: KUMC
state: Kansas
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Rivus Wellness & Research Institute
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon)
state: Oregon
city: Philadelphia
country: United States
facility: UPenn
state: Pennsylvania
city: Lincoln
country: United States
facility: BTC of Lincoln
state: Rhode Island
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, L.P.
state: Texas
city: Dallas
country: United States
facility: UTSW
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research
state: Texas
city: Clinton
country: United States
facility: Ericksen Research & Development
state: Utah
city: Waukesha
country: United States
facility: IPC Research
state: Wisconsin
Study officials:
References:
citation: Jha MK, Fava M, Freeman MP, Thase ME, Papakostas GI, Shelton RC, Trivedi MH, Dirks B, Liu K, Stankovic S. Effect of Adjunctive Pimavanserin on Sleep/Wakefulness in Patients With Major Depressive Disorder: Secondary Analysis From CLARITY. J Clin Psychiatry. 2020 Dec 1;82(1):20m13425. doi: 10.4088/JCP.20m13425.
citation: Fava M, Dirks B, Freeman MP, Papakostas GI, Shelton RC, Thase ME, Trivedi MH, Liu K, Stankovic S. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY). J Clin Psychiatry. 2019 Sep 24;80(6):19m12928. doi: 10.4088/JCP.19m12928.