Efficacy Study of a Computer Decision Support System to Treat Depression

Not Applicable

Completed

• Conditions: Depressive Disorder

• Registration Number: NCT00551083
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The purpose of this study was designed to test the feasibility and effectiveness of implementing a Computerized Decision Support System for depression (CDSS-D) during acute care in a primary care setting.

Detailed Description

The research project was designed to test the feasibility and effectiveness of implementing a Computerized Decision Support System for depression (CDSS-D) during acute care in a primary care setting. The basic experimental design was a two-group, two-site study design. Three different clinics with a total of 4 primary care physicians agreed and provided informed consent and participated in the study. Half of the physicians used the CDSS-D to treat patients with MDD and the other half provided Usual Care (UC) treatment.

The intervention, CDSS-D, incorporated a pre-existing depression treatment algorithm (Texas Medication Algorithm Project for Depression, Trivedi et al) with computer decision support programming, providing the treatment group physicians with a computerized algorithm.

Study Timeline

• Study Start: 2005-03
• Study Completion: 2006-06
• Status Verified: 2007-10
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Last Update Submitted: 2007-10-29
• Study First Posted: 2007-10-30
• Last Update Posted: 2007-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Outpatients aged 18 and over
• Met Criteria for Non-Psychotic Major Depressive Disorder
• Had a baseline HRSD-17 score of at least 14

Exclusion Criteria

• Patients with a current Axis I diagnosis of somatization disorder, anorexia nervosa, bulimia, or obsessive-compulsive disorder
• Patients with current alcohol or substance dependence
• Women with a positive pregnancy test or who are lactating
• Women of child-bearing potential who are not practicing a clinically accepted method of contraception
• Patients with general medical conditions that contraindicate antidepressant medications
• Patient whose clinical status requires inpatient or day hospital treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score	24 weeks

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)	24 weeks
Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)	24 weeks