Depressive DisorderCDSS-DNCT00551083
Efficacy Study of a Computer Decision Support System to Treat Depression
A study testing Computerized Decision Support System for Depression (CDSS-D) in people with Depressive Disorder, run by University of Texas Southwestern Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Computerized Decision Support System for Depression (CDSS-D)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients aged 18 and over
- Met Criteria for Non-Psychotic Major Depressive Disorder
- Had a baseline HRSD-17 score of at least 14
Who cannot join
- 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
About this study
Official title: A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care
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.
Read the 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.
- Conditions
- Depressive Disorder
- Being tested
- Computerized Decision Support System for Depression (CDSS-D), Usual Care (UC)
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Usual Care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score
Measured: 24 weeks
Secondary outcomes (2)
Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)
Measured: 24 weeks
Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startMar 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Madhukar H. Trivedi, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551083
- Sponsor's protocol ID
- S1143107
- Other IDs
- R01 MH-164062-01A1
- Acronym
- CDSS-D
- Status last verified
- Oct 2007
- First submitted
- 29 Oct 2007
- Last updated
- 30 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19750065
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT00551083
- Acronym / sponsor ID
- CDSS-D / S1143107
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 30 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDSS-D | Experimental | Other: Computerized Decision Support System for Depression (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 |
| UC | Active comparator | Other: Usual Care (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients aged 18 and over
- Met Criteria for Non-Psychotic Major Depressive Disorder
- Had a baseline HRSD-17 score of at least 14
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | CDSS-D |
| 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. | Other | UC |
Primary outcome
Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score
Time frame: 24 weeks
2 secondary outcomes
Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)
Time frame: 24 weeks
Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2007.
- Derived from this study: PubMed 19750065Kurian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar H. Trivedi, M.D. principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Decision Support System for Depression (CDSS-D) in people with Depressive Disorder, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00551083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2007.