NL-OMON50802尚未招募4 期
Efficacy of repetitive transcranial magnetic stimulation in patients with medication-resistant bipolar depression. A multicenter, randomized, double-blind, sham-controlled study - T-Bide
Amsterdam UMC0 个研究点目标入组 166 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •Eligibility criteria:
- •- 18 years or older of age;
- •- Sufficient level of spoken and written Dutch;
- •- Ability to freely provide written informed consent;
- •- patients with bipolar I or Il disorder, who have a medication-resistant
- •bipolar depression, i.e., lack of remission for eight consecutive weeks after
- •two different adequate medication trials with at least two recommended
- •monotherapy treatments or at least one monotherapy treatment and another
- •combination
- •- A score > 16 points on the Hamilton depression rating scale for atypical
- •depression (SIGH-ADS).
- •- A current DSM-5 diagnosis of bipolar depression, ascertained by the Mini
- •International Neuropsychiatry Interview (MINI-plus).
- •- Or have tried at least two monotherapies in the previous depressive episode,
- •which must have occurred within 12 months previous of the present episode but
- •not more than three depressive episodes within these 12 months.
- •- Stable medication 4 weeks prior to study, including anti-manic medication,
- •consisting of lithium, valproate, carbamazepine and all anti-psychotic drugs,
- •in patients with bipolar I disorder. Patients with a bipolar 2 disorder using
- •anti-depressant medication will also need to use anti-manic medication. 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
- •Partcipants meeting any of the following criteria will be excluded from
- •participation in this study:
- •- A (hypo)manic episode within 3 months before the start of the trial.
- •- A Young Mania Rating Scale score > 12, before the start of the trial.
- •- Current psychotic disorder, including psychotic depression, assessed at the
- •baseline interview.
- •- Dementia, assessed with a dementia screening tool, i.e. the Montreal
- •Cognitive Assessment (34), assessed at the baseline interview.
- •- 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?.
- •- Metallic devices implanted above the neck, assessed at the baseline
- •- Patients diagnosed with epilepsy, by a neurologist, assessed at the baseline
- •- Patients with bipolar Il disorder who use anti-depressant medication without
- •anti-manic medication or patients with bipolar I disorder, not using anti-manic
- •medication.
- •- 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.
- •- Pregnancy, If there is any doubt a pregnancy test is performed, at baseline.
- •- Known with rapid cycling.; e.g. more than 3 mood cycles per year.
- •- Inability to understand or comply with study requirements as judged by the
- •investigators, assessed at the baseline interview.
- •- Earlier experiences with rTMS (as treatment or in a study)
研究者
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