Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
- Conditions
- Major Depressive Disorder Without Psychotic Features
- Interventions
- Drug: Asenapine 5-20 mg dailyDrug: Placebo 1-4 tablets daily
- Registration Number
- NCT01670019
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
-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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Asenapine 5-20 mg daily 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 Placebo 1-4 tablets daily 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
- Primary Outcome Measures
Name Time Method Change in MADRS Total Score 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 Outcome Measures
Name Time Method Clinical Remission Rate 6 weeks Clinical Remission will be defined as the number of participants with a MADRS total score \< 7.
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.Study Completion Rate 6 weeks The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks
Rates of Sustained Remission 2, 4, 6 weeks Sustained remission will be defined as at least two consecutive post-randomization assessments (weeks 2, 4, and 6) during which minimal depressive psychopathology (MADRS \< 7) is present.
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.Clinical Response Rate Baseline, 6 weeks Clinical Response rate will be defined as the number of participants with a \> 50% reduction from baseline in MADRS total score.
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.
Trial Locations
- Locations (5)
Georgia Health Sciences University
🇺🇸Augusta, Georgia, United States
Brody School of Medicine at East Carolina University
🇺🇸Greenville, North Carolina, United States
North Carolina Psychiatric Research Center
🇺🇸Raleigh, North Carolina, United States
Carolina Behavioral Care
🇺🇸Durham, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States