An interventional study of Sertraline and Venlafaxine Extended Release in Depression and Depressive Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-08-20.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
This study will develop an intervention that will increase the retention of Hispanics with major depression in antidepressant therapy.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is an open trial so there is only one arm using standard antidepressant medications.
Drug: Sertraline · Drug: Venlafaxine Extended Release
Retention percentage
The proportion of weeks in treatment
Time frame: 12 weeks
Depressive symptoms on the Hamilton Depression scale
Time frame: 12 weeks
Number of days in treatment
Sum of days in treatment
Time frame: 84 days
Functional impairment on the Sheehan Disability Scale
Time frame: 12 weeks
Perceived quality of life
Time frame: 12 weeks
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute