Improving Retention of Hispanics Receiving Antidepressant Therapy

Not Applicable

Completed

• Conditions: Depression; Depressive Disorder
• Interventions: Drug: Sertraline; Drug: Venlafaxine Extended Release

• Registration Number: NCT00057642
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

This study will develop an intervention that will increase the retention of Hispanics with major depression in antidepressant therapy.

Detailed Description

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-04-04
• Study First Submitted QC: 2003-04-04
• Study First Posted: 2003-04-08
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2008-09
• Last Update Submitted: 2013-08-16
• Last Update Posted: 2013-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnostic Statistical Manual, 4th edition criteria for Major Depressive Disorder
• Patients who self-identify as Hispanic and are Spanish-dominant, English-dominant, or bilingual
• Acceptable methods of contraception
• Hamilton Depression Rating Scale score >= 18 at Visit 1
• Sertraline or venlafaxine ER is clinically appropriate

Exclusion Criteria

• History of schizophrenia, bipolar affective disorder, schizoaffective disorder, depression with psychotic symptoms, or organic brain syndrome
• DSM-IV criteria for alcohol or substance abuse or dependence during the 6 months prior to screening
• Pregnancy or breast-feeding
• At risk for committing suicide
• Clinically significant renal, pulmonary, cerebrovascular, cardiovascular, gastrointestinal, or endocrine disorders
• Glaucoma, history of increased intraocular pressure (IOP), or at risk for having increased IOP
• Untreated or unstable hypertension
• Clinically significant laboratory abnormalities or abnormal electrocardiogram
• Medical conditions that might interfere with the process of drug absorption, metabolism, or elimination
• Clinically significant thyroid dysfunction (except patients who are stable and asymptomatic on thyroid replacement therapy)
• Current or past history of seizure disorder (except febrile seizure in childhood)
• History of failed sertraline or venlafaxine treatment for at least 4 weeks at adequate doses
• Allergy or hypersensitivity to sertraline or venlafaxine
• History of two failed selective serotonin reuptake inhibitor (SSRI) trials for major depression at adequate doses and duration
• Monoamine oxidase inhibitors (MAOIs) or fluoxetine within 4 weeks prior to screening, or other SSRIs, antidepressants, neuroleptics, mood stabilizers, buspirone, benzodiazepines, or other psychotropic drugs (except zolpidem for insomnia) within 2 weeks prior to screening
• Electroconvulsive Therapy (ECT) within the last 3 months
• Effective medication or psychotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sertraline, venlafaxine, bupropion	Venlafaxine Extended Release	This is an open trial so there is only one arm using standard antidepressant medications.
Sertraline, venlafaxine, bupropion	Sertraline	This is an open trial so there is only one arm using standard antidepressant medications.

Primary Outcome Measures

Name	Time	Method
Retention percentage	12 weeks	The proportion of weeks in treatment

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms on the Hamilton Depression scale	12 weeks
Number of days in treatment	84 days	Sum of days in treatment
Functional impairment on the Sheehan Disability Scale	12 weeks
Perceived quality of life	12 weeks

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States