NCT00136240

Brief Summary

This study will determine the efficacy of a computerized telephone system called Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in people with depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Apr 2003

Typical duration 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

April 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

July 25, 2013

Status Verified

August 1, 2008

Enrollment Period

2.8 years

First QC Date

August 25, 2005

Last Update Submit

July 24, 2013

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • Antidepressant medication adherence

    Measured monthly for 4 months

  • Adherence to scheduled psychiatry clinic visits

    Measured monthly for 4 months

Secondary Outcomes (2)

  • Depression status, measured by self-administered depression inventory scale

    Measured at baseline and at 4 month follow-up

  • General health status, measured by self-rating health survey

    Measured at baseline and at 4 month follow-up

Interventions

Computer Assisted Education for Behavior ChangeBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • A clinical diagnosis of major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or any combination of the three
  • Prescribed at least one antidepressant medication
  • Access to a telephone with touch-tone service
  • Speak and understand conversational English

You may not qualify if:

  • Current significant alcohol or drug abuse
  • Clinical diagnosis of bipolar disorder, schizoaffective disorder, or significant personality disorder
  • Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), or other neurodegenerative diseases
  • Alzheimer's disease and other dementia
  • Cancer, undergoing radiation therapy or chemotherapy
  • Suffering from Renal disease or on dialysis
  • Immunologic disorder (rheumatoid arthritis, systemic lupus erythematosus \[SLE\], etc.)
  • HIV
  • Terminal illness
  • Homeless
  • Legally blind
  • Planning to leave the geographic area during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Ramesh Farzanfar

    Boston University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

April 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

July 25, 2013

Record last verified: 2008-08

Locations

US(1)