Skip to main content

Table 1 Eligibility criteria for the DAD study

From: Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

Inclusion criteria
- Type 1 or type 2 diabetes mellitus diagnosed at least 12 months before entering the trial
- Insulin treatment for at least the preceding 6 months
- 21 to 69 years of age (amended to protocol in August 2006) Initially: 21 to 65 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 (<1 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 12 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 6 months
- Insufficient ability to understand German
- Psychotherapy in the preceding 3 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 2 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
  1. Note: All changes in eligibility criteria were amended to the protocol during the trial and before breaking of the blinding.