At a glance
ClinicalIndex Comparison Record- ✓Age 18-64 years
- ✓DSM-IV diagnosis of major depressive disorder confirmed by SCID I/P
- ✓Current DSM-IV diagnosis of alcohol abuse or dependence confirmed by SCID I/P
- ✓Written informed consent
- ✕Suicidal ideation where outpatient treatment determined unsafe by study clinician
- ✕Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- ✕History of seizure disorder, brain injury, or known neurological disease (MS, ALS, Parkinson's, movement disorders)
- ✕Untreated hypothyroidism (clinical or lab evidence)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Placebo-Controlled Study of Acamprosate Added to Escitalopram and Behavioral Treatment in Major Depressive Disorder (MDD) With Comorbid Alcohol Abuse/Dependence
In Brief
A Phase 4 clinical trial evaluating acamprosate, escitalopram, and 2 other interventions for Major Depressive Disorder and 2 related conditions. Completed, enrolled 23 participants across 1 site.
Detailed Summary
This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence. The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population.
Study Details
Timeline
Interventions
Acamprosate 333mg, 2 capsules by mouth (i.e., PO), three times per day (i.e., TID), for 12 weeks.
Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg PO once per day (i.e., QD) with the possibility of increasing to 30mg PO QD.
Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).
Placebo, 2 capsules PO TID, for 12 weeks