Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
This trial is active, not recruiting.
|Condition||major depressive disorder without psychotic features|
|Treatments||asenapine 5-20 mg daily, placebo 1-4 tablets daily|
|Collaborator||Merck Sharp & Dohme Corp.|
|Start date||October 2012|
|End date||July 2014|
|Trial size||130 participants|
|Trial identifier||NCT01670019, Pro00037462|
This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone.
The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Augusta, GA||Georgia Health Sciences University||no longer recruiting|
|Durham, NC||Duke University Medical Center||no longer recruiting|
|Durham, NC||Carolina Behavioral Care||no longer recruiting|
|Greenville, NC||Brody School of Medicine at East Carolina University||no longer recruiting|
|Raleigh, NC||North Carolina Psychiatric Research Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change in MADRS total score
time frame: Baseline, 6 weeks
Study completion rate
time frame: 6 weeks
Rates of response, remission, and sustained remission
time frame: 6 weeks
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: -130 male or female patients, 18-65 years of age, with: 1. DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI) 2. MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization 3. Inadequate therapeutic response during their current depressive episode; an inadequate therapeutic response will be defined as continued depressive psychopathology (see criterion 2) following > six weeks of therapy at adequate doses (according to the US label) of any non-tricyclic, non-MAOI antidepressant medication Exclusion Criteria: 1. Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to enrollment 2. DSM-IV Axis II diagnoses that significantly impact the current psychiatric status 3. Current MDD episode lasting > 12 months 4. Electroconvulsive therapy within the preceding 6 months 5. Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment 6. Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE <24) 7. Risk of suicide as defined by MADRS item 10 score > 4 8. Prior failure to respond to asenapine 9. Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline 10. Hepatic impairment and history of low WBC, by medical history and interview.
|Official title||A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy|
|Principal investigator||John Beyer, MD|
|Description||The investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone.|
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