Efficacy Study of a Computer Decision Support System to Treat Depression

Depressive Disorder Clinical Trial

— CDSS-D  

Official title:

A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551083
• Other study ID #: S1143107
• Secondary ID: R01 MH-164062-01
• Status: Completed
• Phase: N/A
• First received: October 29, 2007
• Last updated: October 29, 2007
• Start date: March 2005
• Est. completion date: June 2006

Study information

• Verified date: October 2007
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Computerized Decision Support System for Depression (CDSS-D)
The CDSS for depression was based on an up-to-date model of the Texas Medication Algorithm Project that employs the principles of Measurement Based Care (MBC), while at the same time having a user interface for providers that is easy-to-use. MBC is the systematic use of measuring clinical outcomes at routine visits to guide treatment management. These outcomes may include symptoms, side effects, and medication adherence. Recent efforts from the large, multi-site effectiveness study, Sequenced Treatment Alternatives to Relieve Depression (STAR*D), show that a treatment plan guided by MBC is integral in implementing algorithm based care.
• Usual Care (UC)
Usual Care was up to the discretion of the study physician and the patient treated. These physicians were provided with up-to-date treatment protocols for depression, but were not instructed to strictly adhere to a treatment algorithm. Therefore, they treated depressed patients as they "usually" would.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score		24 weeks
Secondary	Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)		24 weeks
Secondary	Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)		24 weeks