- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03018340
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- UAB
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Arkansas
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Rogers, Arkansas, United States, 72758
- Woodland Research Northwest
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California
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Garden Grove, California, United States, 92845
- Collaborative Neuroscience Network, LLC
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National City, California, United States, 91950
- Synergy San Diego
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Oakland, California, United States, 94607
- Pacific Research Partners, LLC
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Sherman Oaks, California, United States, 91403
- Schuster Medical Research Institute
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Temecula, California, United States, 92591
- Viking Clinical Research
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Torrance, California, United States, 90502
- Collaborative Neuroscience Network, LLC
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Upland, California, United States, 91786
- Pacific Clinical Research Medical Group
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Florida
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Bradenton, Florida, United States, 34201
- Meridien Research
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Jacksonville, Florida, United States, 32256
- CNS Health care (Jacksonville)
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Maitland, Florida, United States, 32751
- Meridien Research
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Orlando, Florida, United States, 32801
- CNS Health Care (Orlando)
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Georgia
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Atlanta, Georgia, United States, 30329
- Emory University School of Medicine
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Decatur, Georgia, United States, 30030
- iResearch Atlanta
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Illinois
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Chicago, Illinois, United States, 60612
- Alam Medical Research, INC
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Hoffman Estates, Illinois, United States, 60169
- Alexian Brothers Center for Psychiatric Research
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Kansas
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Wichita, Kansas, United States, 67214
- KUMC
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Missouri
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Saint Louis, Missouri, United States, 63141
- St. Louis Clinical Trials
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Nevada
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Las Vegas, Nevada, United States, 89102
- Altea Research
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New Jersey
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Berlin, New Jersey, United States, 08009
- Hassman Research Institute
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New York
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New York, New York, United States, 10036
- Manhattan Behavioral Medicine
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Rochester, New York, United States, 14618
- Finger Lakes Clinical Research
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Ohio
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Canton, Ohio, United States, 44718
- Neuro-Behavioral Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- IPS Research
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Oklahoma City, Oklahoma, United States, 73112
- Rivus Wellness & Research Institute
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Oregon
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Portland, Oregon, United States, 97210
- Summit Research Network (Oregon)
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- UPenn
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Rhode Island
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Lincoln, Rhode Island, United States, 02865
- BTC of Lincoln
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South Carolina
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Charleston, South Carolina, United States, 29407
- Carolina Clinical Trials, Inc.
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Texas
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Dallas, Texas, United States, 75231
- FutureSearch Trials of Dallas, L.P.
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Dallas, Texas, United States, 75235
- UTSW
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Richardson, Texas, United States, 75080
- Pillar Clinical Research
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Utah
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Clinton, Utah, United States, 84015
- Ericksen Research & Development
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Wisconsin
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Waukesha, Wisconsin, United States, 53188
- IPC Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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.
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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.
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PLACEBO_COMPARATOR: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline to Week 5 in the HAMD-17 Total Score
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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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.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Week 5 in the SDS Total Score
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The Sheehan Disability Scale is a 3-item patient-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility.
All items are rated on an 11-point scale from 0 (no impairment) to 10 (most severe).
The total SDS score ranges from 0 to 10.
It is calculated as the arithmetic mean of the scores for all 3 items.
A higher score indicates greater disability.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Treatment Response and Remission Rates at the End of 5-week Treatment Period
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. 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. A higher total score indicates more severe depression. Treatment response was defined as a reduction from Baseline in HAMD-17 total score of >=50%. Remission was defined as a HAMD-17 total score <=7. |
Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Change From Baseline to Week 5 in CGI-S Total Score
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The Clinical Global Impression-Severity Scale is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients).
A higher CGI-I score denotes more severe depression.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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CGI-I Score at Week 5
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The Clinical Global Impression- Improvement scale is a 1-item scale, used to rate the global improvement of the patient since beginning of the study from 0 (not assessed) to 7 (very much worse).
A higher CGI-I score denotes less improvement in depression.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Change From Baseline to Week 5 in SF-12 Score
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The 12-Item Short Form Health Survey is a patient-reported outcome measure that addresses 8 domains of physical functioning, role - physical, bodily pain, general health perceptions, vitality, social functioning, role - emotional, and mental health.
Composite scores were obtained representing physical health and mental health composite summaries, Physical Component Summary (PCS) and Mental Component Summary (MCS), respectively.
An algorithm was used to generate PCS and MCS for comparison to normative data.
In normative data, the mean score was set to 50; thus, scores >50 indicate better physical or mental health than the mean and scores <50 indicate worse health.
A higher score is indicative of a better health state.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Change From Baseline to Week 5 in DAI-10 Score
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The Drug Attitude Inventory-10 is a 6-item patient-facing questionnaire to evaluate a patient's perceptions and experiences of treatment.
It contains 6 items that a patient who is fully adherent to prescribed medication would answer as "True," and 4 items that a patient who is fully adherent would rate as "False."
Scores are allocated to each answer and the total score is calculated as the sum.
A correct answer is scored +1 and an incorrect answer is scored -1.
The total score ranges from -10 to 10 and is the sum of pluses and minuses.
A positive total score indicates a positive subjective response (adherent) and a negative total score indicates a negative subjective response (nonadherent).
Higher scores denoted better adherence.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Change From Baseline to Week 5 in KSS Score
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The Karolinska Sleepiness Scale is a patient-facing 1-item scale that measures the patient's drowsiness.
Scoring is based on a 9-point verbally anchored scale ranging from "extremely alert" (1) to "very sleepy, great effort to keep awake, fighting sleep" (9).
Higher scores denote more drowsiness.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Change From Baseline to Week 5 in MGH-SFI Score
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The Massachusetts General Hospital Sexual Functioning Index is a patient-facing questionnaire that quantifies sexual dysfunction into 5 functional domains ("interest in sex," "sexual arousal," "ability to achieve orgasm," "ability to maintain erection" [males only], and "sexual satisfaction").
Patients rate each item using a 6-point scale ranging from 1 (good function) to 6 (poor function).
The MGH-SFI score is calculated as the arithmetic mean of the item scores for the 5 domains.
The mean MGH-SFI score ranges from a minimum value of 1 to a maximum value of 6.
Higher scores denotes worse sexual dysfunction.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Change From Baseline to Week 5 in BIS-11 Score
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The Barratt Impulsiveness Scale-11 is a questionnaire for assessment of the personality/behavioral construct of impulsiveness.
It is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences.
Items are scored on a 4-point scale from Rarely/Never (1) to Almost Always/Always (4).
Items are summed up to calculate the total score.
The BIS-11 total score ranges from 30 to 120.
Higher scores denotes more impulsiveness.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Change From Baseline to Week 5 in SIS Score
Time Frame: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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The Sheehan Irritability Scale is a 7-item patient-reported outcome measure to measure the frequency, severity, and impairment associated with irritability in psychiatric patients.
It includes items on: irritability, frustration, edginess/ impatience/ overreaction, moodiness, anger with self, anger with others, and temper.
Items are answered on an 11-point rating scale where higher scores indicated greater severity (0=not at all, 10=extremely).
Item responses are summed into a total score (range=0-70).
Higher scores mean higher irritability.
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Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Pimavanserin
Other Study ID Numbers
- ACP-103-042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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