Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder Without Psychotic Features

In brief

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.

Key facts

Study ID

NCT01670019

Run by

Duke University

People needed

46

Starts

2012-10-01

Expected to finish

2014-06-01

Last updated by the study team

2015-10-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Georgia Health Sciences University — Augusta, Georgia, United States
• Carolina Behavioral Care — Durham, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.