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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
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 29, 2007
    Last Updated
    October 29, 2007
    Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    Pfizer
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    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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