Improving Retention of Hispanics Receiving Antidepressant Therapy
This study will develop an intervention that will increase the retention of Hispanics with major depression in antidepressant therapy.
Drug: Venlafaxine Extended Release
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Improving Hispanic Retention in Antidepressant Therapy|
- Retention percentage [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The proportion of weeks in treatment
- Depressive symptoms on the Hamilton Depression scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Number of days in treatment [ Time Frame: 84 days ] [ Designated as safety issue: No ]Sum of days in treatment
- Functional impairment on the Sheehan Disability Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Perceived quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2002|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Sertraline, venlafaxine, bupropion
This is an open trial so there is only one arm using standard antidepressant medications.
|Drug: Sertraline Drug: Venlafaxine Extended Release|
Despite major advances in the treatment of psychiatric disorders, Hispanics continue to underutilize mental health services relative to their own mental health needs. Cultural factors are important causes of underutilization. To date, however, attempts to boost utilization by improving the cultural congruence of psychiatric services have not focused on retaining Hispanics in antidepressant therapy.
Motivational Interviewing (MI) is a time-limited psychotherapy that has successfully improved treatment retention among patients with dually diagnosed substance abuse and psychiatric disorders. During Phase I of this study, MI is adapted for use as an adjunctive therapy with antidepressant treatment and culturally adapted to Hispanic participants. In Phase II, participants receive sertraline for 12 weeks and participate in four sessions of MI therapy as a supplementary intervention designed to encourage treatment retention. Participants who are intolerant to sertraline or have an inadequate response by Week 6 are switched to venlafaxine ER while continuing to receive MI and to complete study assessments. A follow-up interview is conducted 6 months after the termination of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057642
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Roberto Lewis-Fernandez, MD||Columbia University, NY State Psychiatric Institute|