Improving Retention of Hispanics Receiving Antidepressant Therapy

Improving Hispanic Retention in Antidepressant Therapy

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

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Depression
• Intervention / Treatment: Drug: Sertraline; Drug: Venlafaxine Extended Release

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention percentage	The proportion of weeks in treatment	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Roberto Lewis-Fernandez, MD, Columbia University, NY State Psychiatric Institute

Publications and helpful links

General Publications

• Lewis-Fernandez R, Balan IC, Patel SR, Sanchez-Lacay JA, Alfonso C, Gorritz M, Blanco C, Schmidt A, Jiang H, Schneier F, Moyers TB. Impact of motivational pharmacotherapy on treatment retention among depressed Latinos. Psychiatry. 2013 Fall;76(3):210-22. doi: 10.1521/psyc.2013.76.3.210.

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: April 4, 2003
• First Submitted That Met QC Criteria: April 4, 2003
• First Posted (Estimate): April 8, 2003

Study Record Updates

• Last Update Posted (Estimate): August 20, 2013
• Last Update Submitted That Met QC Criteria: August 16, 2013
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Hispanic Americans
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Sertraline; Venlafaxine Hydrochloride
• Other Study ID Numbers: #4358; R21MH066388 (U.S. NIH Grant/Contract); DSIR SE-SC