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CompletedNCT00057642Updated Aug 20, 2013

Improving Retention of Hispanics Receiving Antidepressant Therapy

An interventional study of Sertraline and Venlafaxine Extended Release in Depression and Depressive Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-08-20.

Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Depression
  • Depressive Disorder

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Keywords

  • Hispanic Americans
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In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

Interventions

  • DrugSertraline
  • DrugVenlafaxine Extended Release
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What researchers measure

Primary outcomes

  1. Retention percentage

    The proportion of weeks in treatment

    Time frame: 12 weeks

Secondary outcomes

  1. Depressive symptoms on the Hamilton Depression scale

    Time frame: 12 weeks

  2. Number of days in treatment

    Sum of days in treatment

    Time frame: 84 days

  3. Functional impairment on the Sheehan Disability Scale

    Time frame: 12 weeks

  4. Perceived quality of life

    Time frame: 12 weeks

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Study locations

1 site
  • New York State Psychiatric Institute
    New York, New York 10032, United States
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References and documents

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. PubMed 23965261 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00057642
Lead sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Apr 8, 2003
Start date
Sep 2002
Primary completion
Aug 2006
Completion
Aug 2006
Last update
Aug 20, 2013

Study contacts

Roberto Lewis-Fernandez, MD
principal investigator · Columbia University, NY State Psychiatric Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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