Expired Study
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New York, New York 10032


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

#4358


NCT ID:

NCT00057642


Secondary ID:

R21MH066388


Study Acronym:


Brief Title:

Improving Retention of Hispanics Receiving Antidepressant Therapy


Official Title:

Improving Hispanic Retention in Antidepressant Therapy


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York State Psychiatric Institute


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Actual


Overall Contact Information

Official Name:Roberto Lewis-Fernandez, MD
Principal Investigator
Columbia University, NY State Psychiatric Institute

Study Dates

Start Date:September 2002
Completion Date:August 2006
Completion Type:Actual
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:September 2008
Last Changed Date:August 16, 2013
First Received Date:April 4, 2003

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Perceived quality of life
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Functional impairment on the Sheehan Disability Scale
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of days in treatment
Time Frame:84 days
Safety Issues:False
Description:Sum of days in treatment
Outcome Type:Secondary Outcome
Measure:Depressive symptoms on the Hamilton Depression scale
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Retention percentage
Time Frame:12 weeks
Safety Issues:False
Description:The proportion of weeks in treatment

Study Interventions

Intervention Type:Drug
Name:Sertraline
Arm Name:Sertraline, venlafaxine, bupropion
Intervention Type:Drug
Name:Venlafaxine Extended Release
Arm Name:Sertraline, venlafaxine, bupropion

Study Arms

Study Arm Type:Other
Arm Name:Sertraline, venlafaxine, bupropion
Description:This is an open trial so there is only one arm using standard antidepressant medications.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York State Psychiatric Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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