Efficacy Study of a Computer Decision Support System to Treat Depression (CDSS-D)
Primary Purpose
Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computerized Decision Support System for Depression (CDSS-D)
Usual Care (UC)
Sponsored by

About this trial
This is an interventional treatment trial for Depressive Disorder
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CDSS-D
UC
Arm Description
Computer Decision Support System for Depression (CDSS-D) - This arm provided physicians with a computerized treatment algorithm and a decision support system to treat their patients suffering Major Depressive Disorder
Usual Care (UC) - This group of physicians treated their patients suffering from Major Depressive Disorder with their standard treatment as usual, and received no algorithm support with regard to treatment decisions
Outcomes
Primary Outcome Measures
Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score
Secondary Outcome Measures
Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)
Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)
Full Information
NCT ID
NCT00551083
First Posted
October 29, 2007
Last Updated
October 29, 2007
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00551083
Brief Title
Efficacy Study of a Computer Decision Support System to Treat Depression
Acronym
CDSS-D
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
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CDSS-D
Arm Type
Experimental
Arm Description
Computer Decision Support System for Depression (CDSS-D) - This arm provided physicians with a computerized treatment algorithm and a decision support system to treat their patients suffering Major Depressive Disorder
Arm Title
UC
Arm Type
Active Comparator
Arm Description
Usual Care (UC) - This group of physicians treated their patients suffering from Major Depressive Disorder with their standard treatment as usual, and received no algorithm support with regard to treatment decisions
Intervention Type
Other
Intervention Name(s)
Computerized Decision Support System for Depression (CDSS-D)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care (UC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)
Time Frame
24 weeks
Title
Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhukar H. Trivedi, M.D.
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19750065
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.
Results Reference
derived
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Efficacy Study of a Computer Decision Support System to Treat Depression
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