CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 665 enrolled
Drug / intervention
SSRI + placebo +2 moredrug
Likely dose
SSRI + placebo 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00590863
NCT00590863Phase 4Completed
CompareCT.gov

Combining Medications to Enhance Depression Outcomes

National Institute of Mental Health (NIMH)·interventional·Posted Jan 11, 2008·Updated Apr 23, 2014

In Brief

A Phase 4 clinical trial evaluating SSRI + placebo, Escitalopram + Bupropion SR, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 665 participants across 15 sites.

Detailed Summary

This study will compare whether a combination of antidepressant medications is better than one antidepressant medication alone when given as initial treatment for people with chronic or recurrent major depressive disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2008
Enrollment StartMar 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.5 years ago

Interventions

SSRI + placebodrug

Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.

Escitalopram + Bupropion SRdrug

Participant will take Burpopion SR (150 to 450 mg/day) + Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.

Venlafaxine XR + Mirtazapinedrug

Participants will take Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.