A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

Completed · Phase 4

Conditions studied: Type 2 Diabetes, Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00939250

Run by

University of Texas Southwestern Medical Center

People needed

20

Starts

2009-10-01

Expected to finish

2011-12-01

Last updated by the study team

2020-09-02

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Family and Community Medicine Clinic, University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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