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A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00939250
First received: July 13, 2009
Last updated: September 21, 2010
Last verified: September 2010
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Depressive Disorder, Major
Diabetes Mellitus
Diabetes Mellitus, Type 2
Behavioral Symptoms
Endocrine System Diseases
Glucose Metabolism Disorders
Mental Disorders
Metabolic Diseases
Mood Disorders

ClinicalTrials.gov processed this record on November 27, 2014