Diabetes And Depression Study
- Conditions
- Type 1 or type 2 diabetes mellitusNutritional, Metabolic, EndocrineDiabetes
- Registration Number
- ISRCTN89333241
- Lead Sponsor
- Ruhr University of Bochum (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 203
Current inclusion criteria as of 08/05/2008:
1. Type 1 or type 2 diabetes mellitus diagnosed at least 12 months beforehand
2. Insulin treatment for at least the past six months
3. 21 to 69 years of age
4. Poor glycaemic control (HbA1c level greater than 7.5% measured twice within the preceding nine months)
5. Current major depression - Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV-TR) criteria
Previous inclusion criteria:
1. Type 1 or type 2 diabetes mellitus diagnosed at least 12 months beforehand
2. Insulin treatment for at least the past six months
3. 21 to 65 years of age
4. Poor glycaemic control (HbA1c level >8% measured twice within the preceding nine months)
5. Current major depression - Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV-TR) criteria
1. Clinically significant suicide risk or history of attempted suicide
2. History of schizophrenia or psychotic symptoms
3. Bipolar disorder
4. Organic brain syndrome or dementia
5. Alcohol or substance abuse or dependence in the past 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current information as of 11/11/2010 due to the amendment of 12/11/2008: <br>Change of glycaemic control (difference in HbA1c value from baseline to the end of the long term phase).<br><br>Initial information at time of registration:<br>Improvement of glycaemic control (minimum 1% decrease in glycosylated haemoglobin A1c test [HbA1c value]) from baseline.
- Secondary Outcome Measures
Name Time Method