Status:
COMPLETED
A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Major Depressive Disorder
Eligibility:
All Genders
21-70 years
Phase:
PHASE4
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00939250
Start Date
October 1 2009
End Date
December 1 2011
Last Update
September 2 2020
Active Locations (1)
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1
Family and Community Medicine Clinic, University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390