NESBID: Neuro-Stimulation of the Brain in Depression. A Randomized, Controlled Clinical Trial of Transcranial Direct Current Stimulation Augmentation, as Compared to Sham Therapy, in the Treatment of Ultra-resistant Major Depressive Disorder
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Depressive Disorder, Major
- 发起方
- University of Alberta
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
- 状态
- 撤回
- 最后更新
- 3个月前
概览
简要总结
In Canada, approximately 20% of patients with Major Depressive Disorder (MDD) have treatment-resistance and fail to respond to trials of pharmacotherapy or psychotherapy. Although the treatment of choice has historically consisted of electroconvulsive therapy (ECT), this is not always feasible or practical, and carries a risk of side-effects that may be unacceptable to certain patients.
In this pragmatic, multi-site, placebo-controlled and double-blinded clinical trial, participants with ultra treatment-resistant MDD will be randomized to receive either active or sham transcranial direct current stimulation in addition to their usual treatment. Ultra treatment-resistant depression will be operationally defined as MDD that has failed to respond to at least five previous trials of antidepressants at sufficient doses, or ECT, or ketamine. Patients will receive a total of 30 active or sham treatment sessions (5 per week), for 30 minutes per session. In both groups, the anode will be placed over the left dorsolateral prefrontal cortex (position F3), and the cathode over the right dorsolateral prefrontal cortex (position F4). Patients in the sham group will receive electrical stimulation at 2 mA for less than 30 seconds, whereas patients in the active group will receive that level of stimulation for the entire duration of treatment.
The study's primary outcome is the change in score on a clinician-graded depression inventory (the Montgomery-Asberg Depression Rating Scales). Secondary outcomes include change in scores on a self-administered depression rating scale and measurement of function scale. Information on language ability will also be collected, as will data on side-effects of treatment. Scores will be collected before the trial start, after every 10 sessions, and one month after trial completion.
研究者
入排标准
入选标准
- •Currently suffering from an MDE with a score on the Montgomery-Åsberg Depression Rating Scale (MADRS) greater than 34 (signifying severe depression)
- •Have ultra treatment resistant MDD (defined as failure to remit despite adequate trials with five antidepressants, or failure to remit with ECT, or failure to remit with ketamine)
排除标准
- •Have been diagnosed with psychosis, an addiction disorder (other than nicotine), borderline personality disorder, or antisocial personality disorder, as these conditions could interfere with adherence to the study protocol
- •Are currently using a herbal compound or known NMDA-modulating agent, as these substances could interfere with the induction of LTP and thereby limit the effectiveness of tDCS
- •Are pregnant, as tDCS has not been adequately studied in this population
- •Have an electronic implant, cardiac dysrhythmia, seizure disorder, neurological disorder, or neurosurgical history, as the safety of electrical stimulation with tDCS cannot be assured given these comorbidities
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
An observer-assessed score of depression severity. The total is scored from 0 to 60, with higher scores representing greater depression severity
次要结局
- FIBSER(Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion)
- Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)(Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion)
- PRISE(Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion)
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)(Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion)
- tDCS adverse events scale(Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion)
- YMRS(Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion)
- Lexical decision making task(Baseline and after 6 weeks/trial completion)
- Exploratory language analysis(Baseline and after 6 weeks/trial completion)