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

Phase 3

Terminated

Conditions: Adjunctive Treatment of Major Depressive Disorder

Interventions: Drug: Pimavanserin

Registration Number: NCT04000009

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 235

Inclusion Criteria

Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059
May benefit from longer term therapy with open-label pimavanserin treatment
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

Is determined to be inappropriate for the study
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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug - pimavanserin	Pimavanserin	Pimavanserin 34 mg tablets

Primary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events (TEAEs)	52 weeks	Number of patients with treatment emergent AEs

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (71): CNS Network
🇺🇸
Garden Grove, California, United States
Behavioral Research Specialists
🇺🇸
Glendale, California, United States
Irvine Clinical Research
🇺🇸
Irvine, California, United States
Synergy San Diego
🇺🇸
Lemon Grove, California, United States
Pacific Research Partners, LLC
🇺🇸
Oakland, California, United States
NRC Research Institute
🇺🇸
Orange, California, United States
MCB Clinical Research centers, LLC
🇺🇸
Colorado Springs, Colorado, United States
Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville
🇺🇸
Jacksonville, Florida, United States
Meridien Research
🇺🇸
Maitland, Florida, United States
Florida Research Center, Inc.
🇺🇸
Miami, Florida, United States
Scroll for more (61 remaining)
CNS Network
🇺🇸Garden Grove, California, United States