Background
Diabetes and depression
Treatment of depression in diabetes
Current status of the trial
Research objectives and endpoints
Primary objective
Principal research question
Primary hypothesis
Secondary objectives
Secondary hypothesis
Secondary endpoints
Methods/Design
Study design, setting, recruitment and procedures
Eligibility criteria (inclusion and exclusion criteria)
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 |
Randomization and blinding
Randomization
Blinding
Interventions
Diabetes education
Diabetes specific cognitive behavioral group therapy (CBT)
Sertraline treatment
No improvement (< 20%) | At least minimal improvement | |||||
---|---|---|---|---|---|---|
(CGI = 0) | (CGI 1 to 3) | |||||
UKU side effects
|
50 mg
|
75-175 mg
|
200 mg
|
50 mg
|
75-175 mg
|
200 mg
|
Absent (0) mild (1) | ⇔ or ⇧ | ⇔ or ⇧ | ⇔ or x
| ⇔ or ⇧ | ⇔ or ⇧ | ⇔ |
Moderate (2) severe (3) |
x
| ⇩ | ⇩ |
x
| ⇩ | ⇩ |
Measures
Primary outcome
Secondary outcomes
Other psychometric measures
Assessment of treatment preference
Assessment of the patient- and therapist perspectives of the (CBT) sessions
Assessment of adherence to treatment
Adherence categories | CBT | Sertraline (randomized sample) | Sertraline (ITT sample) |
---|---|---|---|
Adherent | Participation in ≥ 8 sessions of CBT | 2 measures SER and corresponding ratio DSER:SER in target range | ≥ 5 measures SER and corresponding ratio DSER:SER in target range |
Partially non-adherent | Participation in 1–7 sessions of CBT | 1 measures SER and corresponding ratio DSER:SER in target range | 1-4 measures SER and corresponding ratio DSER:SER in target range |
Non-adherent | No participation in any session of CBT | no measures SER and corresponding ratio DSER:SER in target range | no measures SER and corresponding ratio DSER:SER in target range |
Statistical analysis
Sample size calculation
Analysis of outcome variables
Quality assurance
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Prof. Dr. Ulrich Hegerl, Clinic and Policlinic of Psychiatry and Psychotherapy of the University of Leipzig, Germany.
-
Prof. Dr. Walter Lehmacher, (Institute for Medical Statistics, Informatics and Epidemiology of the University of Cologne, Germany.
-
Prof. Dr. Martin Hautzinger, Eberhard-Karls-University, Institute of Psychology, Department of Clinical and Developmental Psychology, Tuebingen, Germany.