A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00939250

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Major Depressive Disorder	Behavioral: Diabetes and depression intervention Behavioral: Diabetes intervention	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Depression Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Glycosylated Hemoglobin [ Time Frame: week 16, 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quick Inventory of Depressive Symptoms - Self Report [ Time Frame: week 16, 32 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Diabetes and depression intervention Measurement based care for diabetes and depression, disease self management for diabetes and depression	Behavioral: Diabetes and depression intervention Disease self management for diabetes and depression Other Names: Measurement based care Disease self management
Active Comparator: Diabetes intervention Measurement based care for diabetes, disease self management for diabetes	Behavioral: Diabetes intervention Disease self management for diabetes Other Names: Measurement based care Disease self management

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

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939250

Contacts

Contact: David W Morris, Ph.D.

214-648-0162

davidw.morris@utsouthwestern.edu

Locations

United States, Texas
Family and Community Medicine Clinic, University of Texas Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Contact: David W. Morris, Ph.D. 214-648-0162 davidw.morris@utsouthwestern.edu
Principal Investigator: Alison Dobbie, MD, MRCGP

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:	Madhukar H. Trivedi, M.D.	University of Texas Southwestern Medical Center
Study Director:	David W. Morris, Ph.D.	University of Texas Southwestern Medical Center

More Information

No publications provided

Responsible Party:	Madhukar H. Trivedi, M.D., The University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00939250 History of Changes
Other Study ID Numbers:	R34 DK81031
Study First Received:	July 13, 2009
Last Updated:	September 21, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Diabetes
Depression
Disease Self Management
Measurement Based Care

Additional relevant MeSH terms:

Depression
Depressive Disorder
Diabetes Mellitus
Diabetes Mellitus, Type 2
Depressive Disorder, Major
Behavioral Symptoms

Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012