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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

April 4, 2003
August 16, 2013
September 2002
August 2006   (final data collection date for primary outcome measure)
Retention percentage [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The proportion of weeks in treatment
Not Provided
Complete list of historical versions of study NCT00057642 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depression
  • Depressive Disorder
  • Drug: Sertraline
  • Drug: Venlafaxine Extended Release
Sertraline, venlafaxine, bupropion
This is an open trial so there is only one arm using standard antidepressant medications.
Interventions:
  • Drug: Sertraline
  • Drug: Venlafaxine Extended Release
Lewis-Fernández R, Balán IC, Patel SR, Sánchez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2006
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057642
#4358, R21MH066388, DSIR SE-SC
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Roberto Lewis-Fernandez, MD Columbia University, NY State Psychiatric Institute
New York State Psychiatric Institute
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP