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Improving Retention of Hispanics Receiving Antidepressant Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057642
Recruitment Status : Completed
First Posted : April 8, 2003
Last Update Posted : August 20, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Hispanic Retention in Antidepressant Therapy
Study Start Date : September 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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

Primary Outcome Measures :
  1. Retention percentage [ Time Frame: 12 weeks ]
    The proportion of weeks in treatment

Secondary Outcome Measures :
  1. Depressive symptoms on the Hamilton Depression scale [ Time Frame: 12 weeks ]
  2. Number of days in treatment [ Time Frame: 84 days ]
    Sum of days in treatment

  3. Functional impairment on the Sheehan Disability Scale [ Time Frame: 12 weeks ]
  4. Perceived quality of life [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057642

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United States, New York
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)
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Principal Investigator: Roberto Lewis-Fernandez, MD Columbia University, NY State Psychiatric Institute

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: New York State Psychiatric Institute Identifier: NCT00057642    
Other Study ID Numbers: #4358
R21MH066388 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2003    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: September 2008
Keywords provided by New York State Psychiatric Institute:
Hispanic Americans
Additional relevant MeSH terms:
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Depressive Disorder
Mood Disorders
Mental Disorders
Antidepressive Agents
Venlafaxine Hydrochloride
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Antidepressive Agents, Second-Generation