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

Acadia Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Adjunctive Treatment of Major Depressive Disorder

Treatments: Drug: Pimavanserin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04000009

ACP-103-055

2018-003252-20 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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235 participants in 1 patient group

Drug - pimavanserin

Experimental group

Description:

Pimavanserin 34 mg tablets

Treatment:

Drug: Pimavanserin