Clinical trial NCT00551083: Efficacy Study of a Computer Decision Support System to Treat Depression
Official title: A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)
timeFrame: 24 weeks
measure: Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Madhukar H. Trivedi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurian BT, Trivedi MH, Grannemann BD, Claassen CA, Daly EJ, Sunderajan P. A computerized decision support system for depression in primary care. Prim Care Companion J Clin Psychiatry. 2009;11(4):140-6. doi: 10.4088/PCC.08m00687.