NCT00797901

Brief Summary

The purpose of this study was to examine the effect of a new disease management model for depression, the Collaborative Depression Management Program (CDMP), designed to improve clinical outcomes and increase depression treatment in general medical settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable

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

August 1, 2004

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

3.7 years

First QC Date

November 24, 2008

Last Update Submit

August 26, 2014

Conditions

Major Depression

Outcome Measures

Primary Outcomes (3)

  • Depression

    2 months

  • Health-Related Functional Impairment

    2 months

  • Quality of Life

    2 months

Secondary Outcomes (2)

  • Satisfaction with Care

    2 months

  • Barriers to Treatment

    2 months

Study Arms (1)

Collaborative Care, Treatment as Usual

EXPERIMENTAL
Other: Collaborative Care

Interventions

Collaborative CareOTHER
Collaborative Care, Treatment as Usual

Eligibility Criteria

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

You may qualify if:

  • patients ages 18 or older that meet the clinical criteria for major depression.

You may not qualify if:

  • pregnancy, planning a pregnancy, breastfeeding or less than 3 months post-partum
  • severe cognitive impairment
  • ongoing psychiatric treatment
  • do not plan to use the study clinic as a main source of medical care during the next six months
  • a history of bipolar disorder or psychosis
  • those clinically judged to have a high acute suicidal risk
  • unstable or life-threatening medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Puerto Rico

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Mildred Vera, Ph.D.

    University of Puerto Rico

    PRINCIPAL INVESTIGATOR

  • Deborah Juarbe, Ph.D.

    University of Puerto Rico

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

August 1, 2004

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

PR(1)