Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Completed · Phase 3 · Has a placebo group
Conditions studied: Adjunctive Treatment of Major Depressive Disorder
In brief
To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy
Key facts
- Study ID
- NCT03968159
- Run by
- ACADIA Pharmaceuticals Inc.
- People needed
- 298
- Starts
- 2019-04-25
- Expected to finish
- 2020-05-29
- Last updated by the study team
- 2021-11-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients, aged 18 years and above
- A clinical diagnosis of major depressive disorder (MDD)
- Is being treated with one of the following SSRI or SNRI antidepressants:
- Citalopram
- Escitalopram
- Paroxetine
- Fluoxetine
- Sertraline
- Duloxetine
- Venlafaxine
- Desvenlafaxine
- Venlafaxine XR
- Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
- If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception
You may not qualify if…
- Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
- Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
- Has a known history or symptoms of long QT syndrome
- Is determined to be inappropriate for the study for any reason
- 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
- CNS Network — Garden Grove, California, United States
- Behavioral Research Specialists — Glendale, California, United States
- Sun Valley Research Center — Imperial, 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
- Mountain View Clinical Research, Inc. — Denver, Colorado, United States
- CT Clinical Research — Cromwell, Connecticut, 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
- Clinical Trials of America (Monroe, LA) — Monroe, Louisiana, United States
- Adams Clinical — Watertown, Massachusetts, United States
- St. Charles Psychiatric Associates-Midwest Research Group — Saint Charles, Missouri, United States
- Integrative Clinical Trials — Brooklyn, New York, United States
- Social Psychiatry Research Institute (SPRI) — Brooklyn, New York, United States
- University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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