EUCTR2005-004525-26-DE进行中（未招募）不适用
Cognitive behavioural therapy vs. sertraline in patients with depression and poorly controlled diabetes mellitus: A randomized controlled trial - DAD
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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