Improving Retention of Hispanics Receiving Antidepressant Therapy

Depression Clinical Trial

Official title:

Improving Hispanic Retention in Antidepressant Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057642
• Other study ID #: #4358
• Secondary ID: R21MH066388DSIR
• Status: Completed
• Phase: N/A
• First received: April 4, 2003
• Last updated: August 16, 2013
• Start date: September 2002
• Est. completion date: August 2006

Study information

• Verified date: September 2008
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Sertraline

• Venlafaxine Extended Release

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention percentage	The proportion of weeks in treatment	12 weeks	No
Secondary	Depressive symptoms on the Hamilton Depression scale		12 weeks	No
Secondary	Number of days in treatment	Sum of days in treatment	84 days	No
Secondary	Functional impairment on the Sheehan Disability Scale		12 weeks	No
Secondary	Perceived quality of life		12 weeks	No