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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 : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE April 25, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment (CLARITY-2)
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Adjunctive Treatment of Major Depressive Disorder
Intervention  ICMJE
  • Drug: Pimavanserin
    Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
  • Drug: Placebo
    Placebo (2×placebo tablets [size- and color-matched to pimavanserin]) administered orally as a single dose once daily
Study Arms  ICMJE
  • Experimental: Drug - pimavanserin
    Pimavanserin 34 mg tablets
    Intervention: Drug: Pimavanserin
  • Placebo Comparator: Placebo
    Placebo tablets
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Becky Howell 609-250-6923 bhowell@ACADIA-Pharm.com
Contact: Jim Harlick 250-382-5265 JHarlick@acadia-pharm.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03968159
Other Study ID Numbers  ICMJE ACP-103-059
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ACADIA Pharmaceuticals Inc.
Study Sponsor  ICMJE ACADIA Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ACADIA Pharmaceuticals Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP