Improving Retention of Hispanics Receiving Antidepressant Therapy
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|ClinicalTrials.gov Identifier: NCT00057642|
Recruitment Status : Completed
First Posted : April 7, 2003
Last Update Posted : August 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression Depressive Disorder||Drug: Sertraline Drug: Venlafaxine Extended Release||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Hispanic Retention in Antidepressant Therapy|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
Sertraline, venlafaxine, bupropion
This is an open trial so there is only one arm using standard antidepressant medications.
|Drug: Sertraline Drug: Venlafaxine Extended Release|
- Retention percentage [ Time Frame: 12 weeks ]The proportion of weeks in treatment
- Depressive symptoms on the Hamilton Depression scale [ Time Frame: 12 weeks ]
- Number of days in treatment [ Time Frame: 84 days ]Sum of days in treatment
- Functional impairment on the Sheehan Disability Scale [ Time Frame: 12 weeks ]
- Perceived quality of life [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|