NCT00057642

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

August 20, 2013

Status Verified

September 1, 2008

Enrollment Period

3.9 years

First QC Date

April 4, 2003

Last Update Submit

August 16, 2013

Conditions

DepressionDepressive Disorder

Keywords

Hispanic Americans

Outcome Measures

Primary Outcomes (1)

  • Retention percentage

    The proportion of weeks in treatment

    12 weeks

Secondary Outcomes (4)

  • Depressive symptoms on the Hamilton Depression scale

    12 weeks

  • Number of days in treatment

    84 days

  • Functional impairment on the Sheehan Disability Scale

    12 weeks

  • Perceived quality of life

    12 weeks

Study Arms (1)

Sertraline, venlafaxine, bupropion

OTHER

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

Drug: SertralineDrug: Venlafaxine Extended Release

Interventions

SertralineDRUG
Sertraline, venlafaxine, bupropion
Venlafaxine Extended ReleaseDRUG
Sertraline, venlafaxine, bupropion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 23965261DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Roberto Lewis-Fernandez, MD

    Columbia University, NY State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2003

First Posted

April 7, 2003

Study Start

September 1, 2002

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

August 20, 2013

Record last verified: 2008-09

Locations

US(1)