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

Stopped early · Phase 3

Conditions studied: Adjunctive Treatment of Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT04000009

Run by

ACADIA Pharmaceuticals Inc.

People needed

235

Starts

2019-06-06

Expected to finish

2021-02-22

Last updated by the study team

2022-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• 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
• CNS Health Care (Orlando) — Orlando, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Synexus Clinical Research — Atlanta, Georgia, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• Collective Medical Research, LLC — Prairie Village, Kansas, United States
• Adams Clinical — Watertown, Massachusetts, United States
• Integrative Clinical Trials — Brooklyn, New York, United States
• Social Psychiatry Research Institute (SPRI) — Brooklyn, New York, United States
• Department of Psychiatry, Icahn School of Medicine at Mount Sinai — New York, New York, United States
• The Medical Research Network, LLC — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Charak Clinical Research Center — Garfield Heights, Ohio, United States
• Summit Research Network (Oregon) Inc. — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• CNS Network — Garden Grove, California, United States

Full record on ClinicalTrials.gov

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