Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder Without Psychotic Features
Intervention: Asenapine 5-20 mg daily (Drug); Placebo 1-4 tablets daily (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s): John Beyer, MD, Principal Investigator, Affiliation: Duke University
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in MADRS total score
Secondary outcome: Study completion rateRates of response, remission, and sustained remission
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Georgia Health Sciences University, Augusta, Georgia 30912, United States
Carolina Behavioral Care, Durham, North Carolina 27704, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Brody School of Medicine at East Carolina University, Greenville, North Carolina 27834, United States
North Carolina Psychiatric Research Center, Raleigh, North Carolina 27603, United States
Additional Information
Starting date: October 2012
Last updated: July 3, 2014
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