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Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)

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ClinicalTrials.gov Identifier: NCT03018340
Recruitment Status : Active, not recruiting
First Posted : January 12, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Adjunctive Treatment of Major Depressive Disorder Drug: Pimavanserin Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder
Study Start Date : December 2016
Actual Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pimavanserin 34 mg
Drug- pimavanserin, 34 mg, taken as two 17 mg tablets, once daily by mouth
Drug: Pimavanserin
Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth

Placebo Comparator: Placebo
Placebo, taken as two tablets, once daily by mouth
Other: Placebo
Placebo, taken as two tablets, once daily by mouth




Primary Outcome Measures :
  1. Change from Baseline to end of efficacy period in HAMD-17 total score [ Time Frame: 10 weeks ]


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 as monotherapy:

    • Citalopram
    • Escitalopram
    • Paroxetine
    • Fluoxetine
    • Sertraline
    • Duloxetine
    • Venlafaxine
    • Desvenlafaxine
    • Venlafaxine XR
  4. Has a history of inadequate response to antidepressant treatments

Exclusion Criteria:

  1. Patient has a psychotic disorder other than MDD
  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).


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): NCT03018340


  Show 37 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03018340     History of Changes
Other Study ID Numbers: ACP-103-042
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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