Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)

Completed · Phase 2 · Has a placebo group

Conditions studied: Adjunctive Treatment of Major Depressive Disorder

In brief

To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an inadequate response to antidepressant therapy

Key facts

Study ID

NCT03018340

Run by

ACADIA Pharmaceuticals Inc.

People needed

207

Starts

2016-12-01

Expected to finish

2018-10-01

Last updated by the study team

2019-11-14

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 as monotherapy:
• Citalopram
• Escitalopram
• Paroxetine
• Fluoxetine
• Sertraline
• Duloxetine
• Venlafaxine
• Desvenlafaxine
• Venlafaxine XR
• Has a history of inadequate response to antidepressant treatments

You may not qualify if…

• Patient has a psychotic disorder other than MDD
• Patient has current evidence of a serious and/or unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
• Patient has a history or symptoms of long QT syndrome
• 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

• UAB — Birmingham, Alabama, United States
• Woodland Research Northwest — Rogers, Arkansas, United States
• Collaborative Neuroscience Network, LLC — Garden Grove, California, United States
• Synergy San Diego — National City, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• Schuster Medical Research Institute — Sherman Oaks, California, United States
• Viking Clinical Research — Temecula, California, United States
• Collaborative Neuroscience Network, LLC — Torrance, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Meridien Research — Bradenton, Florida, United States
• CNS Health care (Jacksonville) — Jacksonville, Florida, United States
• Meridien Research — Maitland, Florida, United States
• CNS Health care (Orlando) — Orlando, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• iResearch Atlanta — Decatur, Georgia, United States
• Alam Medical Research, INC — Chicago, Illinois, United States
• Alexian Brothers Center for Psychiatric Research — Hoffman Estates, Illinois, United States
• KUMC — Wichita, Kansas, United States
• St. Louis Clinical Trials — St Louis, Missouri, United States
• Altea Research — Las Vegas, Nevada, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Manhattan Behavioral Medicine — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Neuro-Behavioral Clinical Research — Canton, Ohio, United States
• IPS Research — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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