DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder Without Psychotic Features

Intervention: Asenapine 5-20 mg daily (Drug); Placebo 1-4 tablets daily (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
John Beyer, MD, Principal Investigator, Affiliation: Duke University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in MADRS total score

Secondary outcome:

Study completion rate

Rates of response, remission, and sustained remission

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Georgia Health Sciences University, Augusta, Georgia 30912, United States

Carolina Behavioral Care, Durham, North Carolina 27704, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Brody School of Medicine at East Carolina University, Greenville, North Carolina 27834, United States

North Carolina Psychiatric Research Center, Raleigh, North Carolina 27603, United States

Additional Information

Starting date: October 2012
Last updated: July 3, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017