ISRCTN16011816进行中（未招募）未知
Efficacy of repetitive Transcranial magnetic stimulation in patients with medication-resistant BIpolar DEpression: a multicenter, randomized, double-blind, sham-controlled study
Amsterdam UMC Location VUmc0 个研究点目标入组 166 人开始时间: 2022年1月31日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 18 years of age or older
- •2. Sufficient level of spoken and written Dutch
- •3. Ability to freely provide written informed consent
- •4. Current DSM-5 diagnosis of a depressive episode in bipolar I or II disorder, ascertained by the Mini International Neuropsychiatry Interview (MINI-plus)
- •5. A Hamilton depression rating score (HDRS) of >16 points: this score will be obtained from the SIGH-ADS, a depression rating scale able to determine the HDRS score and a score for atypical depression
- •6. Have a medication-resistant bipolar depression, defined according to the criteria of Hidalgo-Mazzei, that is, lack of remission for 8 consecutive weeks after two different medication trials, at adequate therapeutic doses, with at least two recommended monotherapy treatments or at least one monotherapy treatment and another combination
- •7. Stable medication 4 weeks prior to the study, including anti-manic medication, consisting of lithium, valproate, carbamazepine and all anti-psychotic drugs, in patients with bipolar I disorder. Dosages of anti-manic medications will be determined between the participant/patient and his/her psychiatrist. Stable medication also includes stable use of benzodiazepines up to a dosage equivalent of 3.0 mg lorazepam
排除标准
- •1. A (hypo)manic episode within 3 months before the start of the trial
- •2. A Young Mania Rating Scale score >12, before the start of the trial
- •3. Current psychotic disorder including psychotic depression, assessed by treating psychiatrist
- •4. Dementia, assessed with a dementia screening tool, i.e. the Montreal Cognitive Assessment (MOCA), assessed at the baseline interview. Scoring below 20 points is an indication of the presence of dementia, this score below 20 points will be used as an exclusion criterium
- •5. Active suicidal thoughts and intent to act on it, assessed at the baseline interview and before the start of the trial. This assessment is based on the Columbia suicide severity rating scale, i.e. question 5 is answered positive Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?”
- •6. Metallic devices implanted above the neck, assessed at the baseline interview
- •7. Patients diagnosed with epilepsy, by a neurologist, assessed at the baseline interview
- •8. Patients with bipolar II disorder who use anti-depressant medication without anti-manic medication or patients with bipolar I disorder, not using anti-manic medication
- •9. Substance abuse 4 weeks prior to the study, including high dosage of benzodiazepine, a dosage equivalent higher than 3.0 mg lorazepam, assessed at the baseline interview
- •10. Pregnancy, if there is any doubt a pregnancy test is performed at baseline
- •11. Previous treatment with rTMS
- •12. Inability to understand or comply with study requirements as judged by the investigators, assessed at the baseline interview
研究者
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