Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
Adjunctive Treatment of Major Depressive Disorder
About this trial
This is an interventional treatment trial for Adjunctive Treatment of Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Sites / Locations
- UAB
- Woodland Research Northwest
- Collaborative Neuroscience Network, LLC
- Synergy San Diego
- Pacific Research Partners, LLC
- Schuster Medical Research Institute
- Viking Clinical Research
- Collaborative Neuroscience Network, LLC
- Pacific Clinical Research Medical Group
- Meridien Research
- CNS Health care (Jacksonville)
- Meridien Research
- CNS Health care (Orlando)
- Emory University School of Medicine
- iResearch Atlanta
- Alam Medical Research, INC
- Alexian Brothers Center for Psychiatric Research
- KUMC
- St. Louis Clinical Trials
- Altea Research
- Hassman Research Institute
- Manhattan Behavioral Medicine
- Finger Lakes Clinical Research
- Neuro-Behavioral Clinical Research
- IPS Research
- Rivus Wellness & Research Institute
- Summit Research Network (Oregon)
- UPenn
- BTC of Lincoln
- Carolina Clinical Trials, Inc.
- FutureSearch Trials of Dallas, L.P.
- UTSW
- Baylor College of Medicine
- Pillar Clinical Research
- Ericksen Research & Development
- IPC Research
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Pimavanserin 34 mg + SSRI/SNRI
Placebo + SSRI/SNRI
Drug- pimavanserin, 34 mg, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.