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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00939250 |
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Date of registration:
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13/07/2009 |
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Primary sponsor: |
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Public title:
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A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
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Scientific title:
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A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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48 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00939250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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David W. Morris, Ph.D. |
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Address:
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Telephone:
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214-648-0162 |
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Email:
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davidw.morris@utsouthwestern.edu |
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Affiliation:
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Name:
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David W Morris, Ph.D. |
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Address:
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Telephone:
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214-648-0162 |
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Email:
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davidw.morris@utsouthwestern.edu |
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Affiliation:
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Name:
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David W. Morris, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas Southwestern Medical Center |
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Name:
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Madhukar H. Trivedi, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas Southwestern Medical Center |
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Key inclusion & exclusion 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
Age minimum:
21 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Type 2 Diabetes
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Intervention(s)
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Behavioral: Diabetes and depression intervention
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Behavioral: Diabetes intervention
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Primary Outcome(s)
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Glycosylated Hemoglobin
[Time Frame: week 16, 32]
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Secondary Outcome(s)
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Quick Inventory of Depressive Symptoms - Self Report
[Time Frame: week 16, 32]
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Secondary ID(s)
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R34 DK81031
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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