Inclusion criteria | |
---|---|
- | Type 1 or type 2 diabetes mellitus diagnosed at least 12Â months before entering the trial |
- | Insulin treatment for at least the preceding 6Â months |
- | 21 to 69Â years of age (amended to protocol in August 2006) Initially: 21 to 65Â years of age |
- | Poor glycemic control: HbA1c level > 7.5% within the nine preceding months, at least 3 months before screening and again in screening measurement (amended to protocol in August 2006/April 2007) Initially: HbA1c value > 8% twice between the preceding 9 months |
- | Current major depression (DSM-IV-TR criteria) |
- | Residence near the coordination institution where CBT treatment will take place (<1Â hour access) |
- | Ability of subject to understand character and individual consequences of clinical trial |
- | Women with child bearing potential in the sertraline group: Women will be informed that women with childbearing potential in the sertraline group should use highly effective birth control methods (e.g. combined oral contraceptives, implants) |
- | Written informed consent |
Exclusion criteria | |
- | Clinically significant suicide risk or history of attempted suicide in the past 12Â months (amended to protocol in April 2007) Initially: Clinically significant suicide risk or history of attempted suicide |
- | History of schizophrenia or psychotic symptoms |
- | Bipolar disorder |
- | Organic brain syndrome or dementia |
- | Alcohol or substance abuse or dependence in the past 6Â months |
- | Insufficient ability to understand German |
- | Psychotherapy in the preceding 3Â months |
- | Pregnant or lactating patient |
- | History of convulsion or seizure disorder |
- | Current use of mood stabilizers, neuroleptics, antidepressants, or benzodiazepines except for |
  (1) continuation of unchangeable stable amitriptyline given to treat painful diabetic neuropathy up to 50 mg per day | |
  (2) short-term use of benzodiazepines (less than 2 weeks) | |
  (3) low-potency neuroleptics in low doses, i.e. less than 300 mg chlorpromazine dose equivalents/day (amended to protocol 08/2006) | |
  Continuation of stable treatment with thyroid hormones is also permitted | |
- | Significant liver enzyme elevations: SGOT (aspartate aminotransferase, AST) or SGPT (alanine aminotransferase, ALT) above 3-fold of normal upper limits or significant other laboratory findings (physician’s decision) |
- | Pre-treatment with reversible MAO inhibitors within the past 2Â weeks or current, unchangeable co-medication with tryptophan, fenfluramine, or serotonin agonists (triptans) |
- | History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product |
- | Participation in other clinical trials and observation period of competing trials, respectively |