A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 46
- Locations
- 5
- Primary Endpoint
- Change in MADRS Total Score
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •130 male or female patients, 18-65 years of age, with:
- •DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI)
- •MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization
- •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
- •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
- •DSM-IV Axis II diagnoses that significantly impact the current psychiatric status
- •Current MDD episode lasting > 12 months
- •Electroconvulsive therapy within the preceding 6 months
- •Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment
- •Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE <24)
- •Risk of suicide as defined by MADRS item 10 score > 4
- •Prior failure to respond to asenapine
- •Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline
- •Hepatic impairment and history of low WBC, by medical history and interview.
Arms & Interventions
Asenapine 5-20 mg daily
Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Intervention: Asenapine 5-20 mg daily (Drug)
Placebo 1-4 tablets daily
Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Intervention: Placebo 1-4 tablets daily (Drug)
Outcomes
Primary Outcomes
Change in MADRS Total Score
Time Frame: Baseline, 6 weeks
The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Secondary Outcomes
- Clinical Remission Rate(6 weeks)
- Study Completion Rate(6 weeks)
- Rates of Sustained Remission(2, 4, 6 weeks)
- Clinical Response Rate(Baseline, 6 weeks)