search
Back to results

Improving Retention of Hispanics Receiving Antidepressant Therapy

Primary Purpose

Depression, Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Venlafaxine Extended Release
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Hispanic Americans

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sertraline, venlafaxine, bupropion

Arm Description

This is an open trial so there is only one arm using standard antidepressant medications.

Outcomes

Primary Outcome Measures

Retention percentage
The proportion of weeks in treatment

Secondary Outcome Measures

Depressive symptoms on the Hamilton Depression scale
Number of days in treatment
Sum of days in treatment
Functional impairment on the Sheehan Disability Scale
Perceived quality of life

Full Information

First Posted
April 4, 2003
Last Updated
August 16, 2013
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00057642
Brief Title
Improving Retention of Hispanics Receiving Antidepressant Therapy
Official Title
Improving Hispanic Retention in Antidepressant Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder
Keywords
Hispanic Americans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertraline, venlafaxine, bupropion
Arm Type
Other
Arm Description
This is an open trial so there is only one arm using standard antidepressant medications.
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Type
Drug
Intervention Name(s)
Venlafaxine Extended Release
Primary Outcome Measure Information:
Title
Retention percentage
Description
The proportion of weeks in treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Depressive symptoms on the Hamilton Depression scale
Time Frame
12 weeks
Title
Number of days in treatment
Description
Sum of days in treatment
Time Frame
84 days
Title
Functional impairment on the Sheehan Disability Scale
Time Frame
12 weeks
Title
Perceived quality of life
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Lewis-Fernandez, MD
Organizational Affiliation
Columbia University, NY State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23965261
Citation
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.
Results Reference
derived

Learn more about this trial

Improving Retention of Hispanics Receiving Antidepressant Therapy

We'll reach out to this number within 24 hrs