NCT00551083

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
Last Updated

October 30, 2007

Status Verified

October 1, 2007

First QC Date

October 29, 2007

Last Update Submit

October 29, 2007

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score

    24 weeks

Secondary Outcomes (2)

  • Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)

    24 weeks

  • Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)

    24 weeks

Study Arms (2)

CDSS-D

EXPERIMENTAL

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)

UC

ACTIVE COMPARATOR

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)

Interventions

Computerized Decision Support System for Depression (CDSS-D)OTHER

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.

CDSS-D
Usual Care (UC)OTHER

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.

UC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients aged 18 and over
  • Met Criteria for Non-Psychotic Major Depressive Disorder
  • Had a baseline HRSD-17 score of at least 14

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19750065DERIVED

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Madhukar H. Trivedi, M.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 30, 2007

Study Start

March 1, 2005

Study Completion

June 1, 2006

Last Updated

October 30, 2007

Record last verified: 2007-10