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Efficacy Study of a Computer Decision Support System to Treat Depression (CDSS-D)

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ClinicalTrials.gov Identifier: NCT00551083
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : October 30, 2007
Sponsor:
Collaborator:
Pfizer
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Other: Computerized Decision Support System for Depression (CDSS-D) Other: Usual Care (UC) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care
Study Start Date : March 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CDSS-D
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
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.

Active Comparator: UC
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
Other: 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.




Primary Outcome Measures :
  1. Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16) [ Time Frame: 24 weeks ]
  2. Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30) [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551083


Sponsors and Collaborators
University of Texas Southwestern Medical Center
Pfizer
Investigators
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Principal Investigator: Madhukar H. Trivedi, M.D. University of Texas Southwestern Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00551083     History of Changes
Other Study ID Numbers: S1143107
R01 MH-164062-01A1
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: October 30, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders