NCT01670019

A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy

Completed Phase 4 Results posted Last updated 31 August 2015

What this trial tests

Phase 4 trial testing Asenapine 5-20 mg daily in Major Depressive Disorder Without Psychotic Features in 46 participants. Completed in 1 June 2014.

Timeline

1 October 2012

Primary endpoint
1 May 2014

1 June 2014

Quick facts

Lead sponsor	Duke University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	46
Start date	1 October 2012
Primary completion	1 May 2014
Estimated completion	1 June 2014
Sites	5 locations across United States

Drugs / interventions tested

• Asenapine 5-20 mg daily — full drug profile →
• Placebo 1-4 tablets daily — full drug profile →

Conditions studied

• Major Depressive Disorder Without Psychotic Features — all drugs for Major Depressive Disorder Without Psychotic Features →

Sponsor

Duke University

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder Without Psychotic Features. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 highe

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.