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Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04000009
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : November 26, 2019
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

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

Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059
  2. May benefit from longer term therapy with open-label pimavanserin treatment
  3. If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

  1. Is determined to be inappropriate for the study
  2. Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program

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 identifier (NCT number): NCT04000009

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Contact: Becky Howell 609-250-6923
Contact: Jim Harlick 2503825265

  Show 38 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

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Responsible Party: ACADIA Pharmaceuticals Inc. Identifier: NCT04000009     History of Changes
Other Study ID Numbers: ACP-103-055
2018-003252-20 ( EudraCT Number )
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: June 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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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
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