Improving Retention of Hispanics Receiving Antidepressant Therapy

New York State Psychiatric Institute

Status

Completed

Conditions

Depression

Depressive Disorder

Treatments

Drug: Venlafaxine Extended Release

Drug: Sertraline

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00057642

DSIR SE-SC

R21MH066388 (U.S. NIH Grant/Contract)

#4358

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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