Phase 4 N=46 Randomized Quadruple-blind Treatment

Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

Major Depressive Disorder Without Psychotic Features

Bottom Line

View on ClinicalTrials.gov: NCT01670019 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2015

Primary outcome: Primary: Change in MADRS Total Score — -14.29; -11.61 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Asenapine 5-20 mg daily (Drug); Placebo 1-4 tablets daily (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in MADRS Total Score	-14.29; -11.61	—
SECONDARY Study Completion Rate	60.87; 100	—
SECONDARY Clinical Response Rate	7; 12	—
SECONDARY Clinical Remission Rate	5; 5	—
SECONDARY Rates of Sustained Remission	4; 4	—

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.

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01670019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.