Improving Retention of Hispanics Receiving Antidepressant Therapy

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00057642

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression Depressive Disorder	Drug: Sertraline Drug: Venlafaxine Extended Release	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Improving Hispanic Retention in Antidepressant Therapy

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Other: Sertraline, venlafaxine, bupropion This is an open trial so there is only one arm using standard antidepressant medications.	Drug: Sertraline Drug: Venlafaxine Extended Release

Arm

Intervention/Treatment

Other: Sertraline, venlafaxine, bupropion

This is an open trial so there is only one arm using standard antidepressant medications.

Drug: Sertraline

Drug: Venlafaxine Extended Release

Outcome Measures

Primary Outcome Measures

Retention percentage [12 weeks]
The proportion of weeks in treatment

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

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

Investigators

Principal Investigator: Roberto Lewis-Fernandez, MD, Columbia University, NY State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT00057642

Other Study ID Numbers:

#4358
R21MH066388
DSIR SE-SC

First Posted:

Apr 8, 2003

Last Update Posted:

Aug 20, 2013

Last Verified:

Sep 1, 2008

Keywords provided by New York State Psychiatric Institute

Hispanic Americans

Additional relevant MeSH terms:

Depressive Disorder

Sertraline

Venlafaxine Hydrochloride

Study Results

No Results Posted as of Aug 20, 2013