NCT00227929

Brief Summary

This study will evaluate the effectiveness of culturally sensitive treatment versus regular care in treating depressed Chinese Americans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jul 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

4.2 years

First QC Date

September 26, 2005

Last Update Submit

December 9, 2013

Conditions

Depression

Keywords

Major Depressive DisorderMDD

Outcome Measures

Primary Outcomes (1)

  • Symptoms of depression; measured at Weeks 2, 6, 10, 14, 18, 22, and 24

Secondary Outcomes (4)

  • Adherence to clinic visits with the primary care physicians; measured at Weeks 2, 6, 10, 14, 18, 22, and 24

  • Quality of life; measured at Weeks 2, 6, 10, 14, 18, 22, and 24

  • Adherence to medication treatment; measured at Weeks 2, 6, 10, 14, 18, 22, and 24

  • Adverse events; measured at Weeks 2, 6, 10, 14, 18, 22, and 24

Interventions

Care ManagementPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Chinese ethnicity
  • Currently depressed as determined by a total score of at least 16 on the CBCI scale
  • Speaks and understands English or Chinese (including Mandarin, Cantonese, and Taiwanese dialect)
  • Willing to participate in follow-up phone calls

You may not qualify if:

  • Currently at risk for suicide
  • Current unstable medical illness
  • Current clinical or laboratory evidence of hypothyroidism
  • Diagnosed with any of the following in addition to depression: organic mental disorder; schizophrenia; delusional disorder; psychotic disorder; bipolar disorder; mood congruent or mood incongruent psychotic features
  • History of treatment by a psychiatrist within 4 months of study entry
  • History of alcohol or substance abuse within 1 year of study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Cove Community Health Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Albert Yeung, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychiatrist

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

July 1, 2003

Primary Completion

September 1, 2007

Study Completion

June 1, 2008

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

US(1)