Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
NCT ID: NCT03018340
Last Updated: 2019-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
207 participants
INTERVENTIONAL
2016-12-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pimavanserin 34 mg + SSRI/SNRI
Drug- pimavanserin, 34 mg, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
Pimavanserin
Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
Placebo + SSRI/SNRI
Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
Placebo
Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
Interventions
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Pimavanserin
Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
Placebo
Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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UAB
Birmingham, Alabama, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Synergy San Diego
National City, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Viking Clinical Research
Temecula, California, United States
Collaborative Neuroscience Network, LLC
Torrance, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Meridien Research
Bradenton, Florida, United States
CNS Health care (Jacksonville)
Jacksonville, Florida, United States
Meridien Research
Maitland, Florida, United States
CNS Health care (Orlando)
Orlando, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
iResearch Atlanta
Decatur, Georgia, United States
Alam Medical Research, INC
Chicago, Illinois, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
KUMC
Wichita, Kansas, United States
St. Louis Clinical Trials
St Louis, Missouri, United States
Altea Research
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Manhattan Behavioral Medicine
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Neuro-Behavioral Clinical Research
Canton, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon)
Portland, Oregon, United States
UPenn
Philadelphia, Pennsylvania, United States
BTC of Lincoln
Lincoln, Rhode Island, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States
UTSW
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Pillar Clinical Research
Richardson, Texas, United States
Ericksen Research & Development
Clinton, Utah, United States
IPC Research
Waukesha, Wisconsin, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ACP-103-042
Identifier Type: -
Identifier Source: org_study_id
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