A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care - NCT00939250-75237 (Clinical Trial 301987)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy301987.aspx
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| City: |
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Dallas |
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State:
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TX |
| Zip Code: |
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75237 |
| Conditions: |
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Type 2 Diabetes - Major Depressive Disorder |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Methodist Charlton Medical Center Clinic
Dallas, TX 75237
United States
Primary Contact:
David W Morris, Ph.D.
Email: davidw.morris@utsouthwestern.edu
Phone: 214-648-0162 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 17, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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