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Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment (CLARITY-2)

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ClinicalTrials.gov Identifier: NCT03968159
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Adjunctive Treatment of Major Depressive Disorder Drug: Pimavanserin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 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
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: Drug - pimavanserin
Pimavanserin 34 mg tablets
Drug: Pimavanserin
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily

Placebo Comparator: Placebo
Placebo tablets
Drug: Placebo
Placebo (2×placebo tablets [size- and color-matched to pimavanserin]) administered orally as a single dose once daily




Primary Outcome Measures :
  1. Change from Baseline in the Hamilton Depression Scale (17 items) (HAMD-17) total score [ Time Frame: 6 Weeks Treatment Duration ]
    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. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.


Secondary Outcome Measures :
  1. Change from Baseline in Sheehan Disability Scale (SDS) score [ Time Frame: 6 Weeks Treatment Duration ]
    The SDS is a 3-item subject-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. Subjects rate each item using an 11-point scale ranging from 0 (not at all) to 10 (extremely). Higher scores denote greater disability.

  2. Change from Baseline in Clinical Global Impression-Severity (CGI-S) score for depressive symptoms [ Time Frame: 6 Weeks Treatment Duration ]
    The CGI-S rates the severity of a subject's depression over the past 7 days and the score ranges from 1 to 7. Higher CGI-S scores denote more severe depression.

  3. Clinical Global Impression-Improvement (CGI-I) score for depressive symptoms [ Time Frame: 6 Weeks Treatment Duration ]
    The CGI-I rates the change in a subject's depression over the past 7 days relative to the subject's symptoms at Baseline and the score ranges from 1 to 7. Higher CGI-I scores denote less improvement in depression.

  4. Change from Baseline in the Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14) [ Time Frame: 6 Weeks Treatment Duration ]
    The CSFQ-14 is a 14-item version of the CSFQ. This is a patient-facing questionnaire, with a male version and a female version. The total score ranging from 14 to 70 will be calculated as the sum of the scores for all 14 items. Higher total scores denote better sexual functioning.

  5. Change from Baseline in Karolinska Sleepiness Scale (KSS) score [ Time Frame: 6 Weeks Treatment Duration ]
    The KSS is a scale that measures the subject's drowsiness and is frequently used in studies measuring subjective sleepiness. Scoring is based on a 9-point verbally anchored scale going from "1 = extremely alert" to "9 = very sleepy, great effort to keep awake, fighting sleep". Higher scores denote more drowsiness.

  6. Treatment responder rates. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more [ Time Frame: 6 Weeks Treatment Duration ]
    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. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more.

  7. Treatment remission rates. Treatment remission is defined as a HAMD-17 total score ≤7 [ Time Frame: 6 Weeks Treatment Duration ]
    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. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Treatment remission is defined as a HAMD-17 total score ≤7.

  8. Change from Baseline in the Hamilton Depression (HAMD) Anxiety/Somatization factor score [ Time Frame: 6 Weeks Treatment Duration ]
    The Anxiety/Somatization factor of the HAMD-17 includes 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. The HAMD-17 Anxiety/Somatization factor score ranging from 0 to 18 will be calculated as the sum of the scores for the 6 items. Higher scores denote more severe anxiety/somatization condition.

  9. Change from Baseline in the Barratt Impulsiveness Scale (BIS-11) [ Time Frame: 6 Weeks Treatment Duration ]
    The BIS-11 is a questionnaire designed to assess the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (reverse scored items: 1, 7, 8, 9, 10, 12, 13, 15, 20, 29, and 30) behaviors and preferences. Items are scored on the following 4-point scale: Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4. For reverse scored items, a response of 1 is recoded to 4; 2 is recoded to 3; 3 is recoded to 2; and 4 is recoded to 1. The BIS-11 score ranging from 30 to 120 will be calculated as the sum of the scores for all 30 items. Higher scores denote more impulsiveness.

  10. Change from Baseline to Week 1 in the HAMD-17 total score [ Time Frame: 1 week (6 Weeks Total Treatment Duration) ]
    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. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968159


Contacts
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Contact: Becky Howell 609-250-6923 bhowell@ACADIA-Pharm.com
Contact: Jim Harlick 250-382-5265 JHarlick@acadia-pharm.com

  Show 38 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03968159     History of Changes
Other Study ID Numbers: ACP-103-059
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Pimavanserin
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action