Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder
1 other identifier
interventional
207
1 country
36
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 10, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedResults Posted
Study results publicly available
November 14, 2019
CompletedNovember 14, 2019
October 1, 2019
1.8 years
January 10, 2017
September 6, 2019
October 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 5 in the HAMD-17 Total Score
The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. 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. Each item is rated from least (0) to most frequent or most severe, as applicable, with highest scores of 2 to 4, depending on the item. Items are summed up to calculate the HAMD-17 total score. The total score ranges from 0 to 52. A higher total score indicates more severe depression.
Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
Secondary Outcomes (10)
Change From Baseline to Week 5 in the SDS Total Score
Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
Treatment Response and Remission Rates at the End of 5-week Treatment Period
Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
Change From Baseline to Week 5 in CGI-S Total Score
Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
CGI-I Score at Week 5
Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
Change From Baseline to Week 5 in SF-12 Score
Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
- +5 more secondary outcomes
Study Arms (2)
Pimavanserin 34 mg + SSRI/SNRI
EXPERIMENTALDrug- 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.
Placebo + SSRI/SNRI
PLACEBO COMPARATORPlacebo, 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
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, 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
You may qualify if:
- 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 as monotherapy:
- Citalopram
- Escitalopram
- Paroxetine
- Fluoxetine
- Sertraline
- Duloxetine
- Venlafaxine
- Desvenlafaxine
- Venlafaxine XR
- Has a history of inadequate response to antidepressant treatments
You may not qualify if:
- Patient has a psychotic disorder other than MDD
- 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
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
UAB
Birmingham, Alabama, 35294, United States
Woodland Research Northwest
Rogers, Arkansas, 72758, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845, United States
Synergy San Diego
National City, California, 91950, United States
Pacific Research Partners, LLC
Oakland, California, 94607, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Viking Clinical Research
Temecula, California, 92591, United States
Collaborative Neuroscience Network, LLC
Torrance, California, 90502, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Meridien Research
Bradenton, Florida, 34201, United States
CNS Health care (Jacksonville)
Jacksonville, Florida, 32256, United States
Meridien Research
Maitland, Florida, 32751, United States
CNS Health care (Orlando)
Orlando, Florida, 32801, United States
Emory University School of Medicine
Atlanta, Georgia, 30329, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Alam Medical Research, INC
Chicago, Illinois, 60612, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
KUMC
Wichita, Kansas, 67214, United States
St. Louis Clinical Trials
St Louis, Missouri, 63141, United States
Altea Research
Las Vegas, Nevada, 89102, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Manhattan Behavioral Medicine
New York, New York, 10036, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Neuro-Behavioral Clinical Research
Canton, Ohio, 44718, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, 73112, United States
Summit Research Network (Oregon)
Portland, Oregon, 97210, United States
UPenn
Philadelphia, Pennsylvania, 19104, United States
BTC of Lincoln
Lincoln, Rhode Island, 02865, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231, United States
UTSW
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Pillar Clinical Research
Richardson, Texas, 75080, United States
Ericksen Research & Development
Clinton, Utah, 84015, United States
IPC Research
Waukesha, Wisconsin, 53188, United States
Related Publications (2)
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.
PMID: 33264819DERIVEDFava 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.
PMID: 31556975DERIVED
MeSH Terms
Interventions
Limitations and Caveats
Interpretation of Stage 2 results is limited by the reduced number of patients vs initial projections anticipated by the protocol.
Results Point of Contact
- Title
- Sr. Dir. Medical Information and Medical Communications
- Organization
- ACADIA Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2017
First Posted
January 12, 2017
Study Start
December 1, 2016
Primary Completion
September 1, 2018
Study Completion
October 1, 2018
Last Updated
November 14, 2019
Results First Posted
November 14, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share