Cognitive behavioural therapy vs. sertraline in patients with depression and poorly controlled diabetes mellitus: A randomized controlled trial - DAD

• Conditions: Patients with insulin-treated type 1 or type 2 diabetes mellitus with depression and HbA1c-value >7,5% ICD E14.90 with F32; MedDRA version: 8.1Level: LLTClassification code 10022497Term: Insulin-dependent diabetes mellitus

• Registration Number: EUCTR2005-004525-26-DE
• Lead Sponsor: Ruhr Universität Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-08
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

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 • poor glycaemic control (HbA1c level > 7,5%) • 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 • Written informed consent must be available before enrollment in the 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, acyesis, im plants).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
• 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 • poor glycaemic control (HbA1c level > 7,5%) • 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 • Written informed consent must be available before enrollment in the 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, acyesis, im plants).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Clinically significant suicide risk or history of attempted suicide in the last 12 months • history of schizophrenia • 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 • significant liver enzyme elevations: SGOT (aspartate aminotransferase, AST) or SGPT (alanine aminotransferase, ALT) above 3-fold of normal upper limits • significant other laboratory findings (physician’s decision). • Current use of mood stabilizers, neuroleptics, anti-epressants, or benzodia-epines except for (1) continuation of unchan-geable stable amitriptyline gi-ven to treat painful diabetic neuropathy up to 50mg per day, and (2) short-term use of benzo-diazepines (less than 2 weeks), and (3) low-potency neuroleptics in low doses (less than 300mg chlorpromazine dose equiva-lents per day) • pre-treatment with reversible MAO inhibitors within the past 2 weeks • current, unchangeable co-medication with tryptophan, fenfluramine, or serotonin agonists (triptans). Continuation of stable treatment with thyroid hormones is permitted. • 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.
;
• Clinically significant suicide risk or history of attempted suicide in the last 12 months • history of schizophrenia • 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 • significant liver enzyme elevations: SGOT (aspartate aminotransferase, AST) or SGPT (alanine aminotransferase, ALT) above 3-fold of normal upper limits • significant other laboratory findings (physician’s decision). • Current use of mood stabilizers, neuroleptics, anti-epressants, or benzodia-epines except for (1) continuation of unchan-geable stable amitriptyline gi-ven to treat painful diabetic neuropathy up to 50mg per day, and (2) short-term use of benzo-diazepines (less than 2 weeks), and (3) low-potency neuroleptics in low doses (less than 300mg chlorpromazine dose equiva-lents per day) • pre-treatment with reversible MAO inhibitors within the past 2 weeks • current, unchangeable co-medication with tryptophan, fenfluramine, or serotonin agonists (triptans). Continuation of stable treatment with thyroid hormones is permitted. • 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified