Efficacy Study of a Computer Decision Support System to Treat Depression

NCT00551083

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Depressive DisorderEfficacy Study of a Computer Decision Support System to Treat Depression
NCT00551083
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy Study of a Computer Decision Support System to Treat Depression
Official Title  ICMJE A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Other: Computerized Decision Support System for Depression (CDSS-D)
  • 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
    Intervention: Other: Usual Care (UC)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2007)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00551083
Other Study ID Numbers  ICMJE S1143107
R01 MH-164062-01A1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Madhukar H. Trivedi, M.D.University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP