Overview

This trial is active, not recruiting.

Condition major depressive disorder without psychotic features
Treatments asenapine 5-20 mg daily, placebo 1-4 tablets daily
Phase phase 4
Sponsor Duke University
Collaborator Merck Sharp & Dohme Corp.
Start date October 2012
End date July 2014
Trial size 130 participants
Trial identifier NCT01670019, Pro00037462

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
asenapine 5-20 mg daily SAPHRIS
5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID
(Placebo Comparator)
Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
placebo 1-4 tablets daily Placebo
One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID

Primary Outcomes

Measure
Change in MADRS total score
time frame: Baseline, 6 weeks

Secondary Outcomes

Measure
Study completion rate
time frame: 6 weeks
Rates of response, remission, and sustained remission
time frame: 6 weeks

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Duke University.