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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00057642 |
This study will develop an intervention that will increase the retention of Hispanics with major depression in antidepressant therapy.
Condition | Intervention |
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Depression Depressive Disorder |
Drug: Sertraline Drug: Venlafaxine Extended Release |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Improving Hispanic Retention in Antidepressant Therapy |
Estimated Enrollment: | 80 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | August 2006 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | R21 MH66388, DSIR SE-SC |
Study First Received: | April 4, 2003 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00057642 |
Health Authority: | United States: Federal Government |
Hispanic Americans |
Depression Mental Disorders Venlafaxine Mood Disorders Sertraline |
Depressive Disorder Urinary Retention Serotonin Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |