Improving Retention of Hispanics Receiving Antidepressant Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00057642
First received: April 4, 2003
Last updated: August 16, 2013
Last verified: September 2008
  Purpose

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


Condition Intervention
Depression
Depressive Disorder
Drug: Sertraline
Drug: Venlafaxine Extended Release

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Hispanic Retention in Antidepressant Therapy

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Retention percentage [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The proportion of weeks in treatment


Secondary Outcome Measures:
  • Depressive symptoms on the Hamilton Depression scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of days in treatment [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    Sum of days in treatment

  • Functional impairment on the Sheehan Disability Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Perceived quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2002
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sertraline, venlafaxine, bupropion
This is an open trial so there is only one arm using standard antidepressant medications.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057642

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Roberto Lewis-Fernandez, MD Columbia University, NY State Psychiatric Institute
  More Information

No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00057642     History of Changes
Other Study ID Numbers: #4358, R21MH066388, DSIR SE-SC
Study First Received: April 4, 2003
Last Updated: August 16, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Hispanic Americans

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Sertraline
Venlafaxine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 19, 2014