- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00939250
A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
September 1, 2020 updated by: Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
The study involves a 32-week randomized controlled trial in primary care of a comprehensive diabetic and depression intervention in patients with type 2 diabetes and comorbid MDD, compared to a group treated with usual care for MDD plus disease self-management and measurement-based care for diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The overarching goal of the study is to translate research-based treatment procedures that have been shown to improve outcomes for both DM and MDD for use in primary care.
More specifically, the aims are: 1) to evaluate the benefits of CDDI in improving diabetic outcomes compared to usual care for MDD plus disease self-management for diabetes; 2) to evaluate the benefits of CDDI in improving depression outcomes compared to the UC for MDD treatment protocol; and 3) to evaluate the benefits of CDDI in terms of improved (1) cardiovascular risk factors (blood pressure, body mass index, lipids, and abdominal fat), (2) levels of exercise and better diet, (3) clinician and patient satisfaction with care, (4) fidelity to treatment guidelines, and (5) cognitive function.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- Family and Community Medicine Clinic, University of Texas Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meets DSM-IV criteria for single or recurrent nonpsychotic MDD, and whom the physician deems it necessary to start on an antidepressant.
- Meets clinical criteria for type 2 diabetes as follows: (1) on pharmacological treatment for type 2 diabetes and/or (2) fasting plasma glucose > 126mg/dL on 2 separate occasions or an abnormal oral glucose tolerance test (OGTT) (2-hours post load glucose ≥ 200mg/dL).
- HbA1C > 7
- Ability and willingness to provide written informed consent
- Hamilton Rating Scale for Depression (HRSD) score ≥ 14
- Not on antidepressant medication for at least 2 weeks prior to screen (or 6 weeks in the case of fluoxetine or monoamine oxidase inhibitors - MAOIs)
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Type 1 diabetes
- General medical conditions that contraindicate use of antidepressant medications
- Unstable medical illnesses, such as uncontrolled hypertension or symptomatic cardiovascular disease, such as congestive heart failure or angina
- Current or past psychotic disorders including bipolar disorder (I, II, or NOS), schizophrenia, or schizoaffective disorder; anorexia; bulimia
- High risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior
- Concomitant pharmacological or psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy; cognitive behavioral therapy; current use of other medications that would be contraindicated with antidepressant treatment, as determined by the study doctor
- History of current substance or alcohol dependence requiring detoxification within the last 6 months
- Currently suicidal or considered a high suicide risk
- Require inpatient treatment for their depression
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diabetes and depression intervention
Measurement based care for diabetes and depression, disease self management for diabetes and depression
|
Disease self management for diabetes and depression
Other Names:
|
Active Comparator: Diabetes intervention
Measurement based care for diabetes, disease self management for diabetes
|
Disease self management for diabetes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycosylated Hemoglobin
Time Frame: week 16, 32
|
week 16, 32
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quick Inventory of Depressive Symptoms - Self Report
Time Frame: week 16, 32
|
week 16, 32
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: David W. Morris, Ph.D., University of Texas Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
July 13, 2009
First Submitted That Met QC Criteria
July 13, 2009
First Posted (Estimate)
July 14, 2009
Study Record Updates
Last Update Posted (Actual)
September 2, 2020
Last Update Submitted That Met QC Criteria
September 1, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 042009-010
- R34DK081031 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on Diabetes and depression intervention
-
The Alliance for Canadian Health Outcomes Research...Canadian Institutes of Health Research (CIHR); Alberta Health & WellnessCompletedDepression | Type 2 Diabetes | Depressive SymptomsCanada
-
CHU de Quebec-Universite LavalCanadian Institutes of Health Research (CIHR); Institut du Savoir Montfort; Chaire...CompletedHealth Knowledge, Attitudes, PracticeCanada
-
Thai Red Cross AIDS Research CentreNational Institutes of Health (NIH); amfAR, The Foundation for AIDS Research; Fogarty International Center of the National Institute of HealthActive, not recruitingDepressive SymptomsThailand
-
The University of Texas at ArlingtonUniversity of Texas Southwestern Medical CenterCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHead and Neck Cancer | Oropharyngeal CancerUnited States
-
Adai Technology (Beijing) Co., Ltd.Not yet recruiting
-
University of ChileHarvard Medical School (HMS and HSDM); Boston Children's Hospital; Wellesley...Unknown
-
Baystate Medical CenterCompleted
-
Limbix Health, Inc.Children's HealthTerminatedDepressive Disorder | Depression | Hematologic Diseases | Depressive Symptoms | Oncology | Weight, Body | Adolescent Behavior | Depressive Episode | Adolescent - Emotional ProblemUnited States
-
University of PittsburghUnited States Department of DefenseCompletedType 2 DiabetesUnited States