Clinical trial NCT00939250: A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Official title: A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Major Depressive Disorder
Keywords: Diabetes
Depression
Disease Self Management
Measurement Based Care
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treated with usual care for MDD plus disease self-management and measurement-based care for diabetes.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycosylated Hemoglobin
timeFrame: week 16, 32
Secondary outcomes:
measure: Quick Inventory of Depressive Symptoms - Self Report
timeFrame: week 16, 32
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Family and Community Medicine Clinic, University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Madhukar H. Trivedi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: David W. Morris, Ph.D.
role: STUDY_DIRECTOR
References: