Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
Status: | Completed |
---|---|
Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/8/2018 |
Start Date: | December 2016 |
End Date: | October 2018 |
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder
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
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
Inclusion Criteria:
1. Adult patients, aged 18 years and above
2. A clinical diagnosis of major depressive disorder (MDD)
3. Is being treated with one of the following SSRI or SNRI antidepressants as
monotherapy:
- Citalopram
- Escitalopram
- Paroxetine
- Fluoxetine
- Sertraline
- Duloxetine
- Venlafaxine
- Desvenlafaxine
- Venlafaxine XR
4. Has a history of inadequate response to antidepressant treatments
Exclusion Criteria:
1. Patient has a psychotic disorder other than MDD
2. 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
3. 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).
We found this trial at
36
sites
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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