ACTRN12622000474752尚未招募2 期
TIDE (Trimetazidine in bipolar depression): A double-blind, randomised, placebo-controlled trial to evaluate the effect of trimetazidine on depressive symptoms in patients with bipolar disorder
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •I.Aged 18-65 years;
- •II.Have a DSM-V diagnosis of bipolar disorder I or II, or bipolar disorder not elsewhere classified (NEC);
- •III.Currently be in a major depressive episode on Structured Clinical Interview for DSM Disorders (SCID-5-RV);
- •IV.Score greater than or equal to 20 on the Montgomery Åsberg Depression Rating Scale (MADRS);
- •V.have the capacity to consent to the study and to follow its instructions and procedures;
- •VI.be using effective contraception if a sexually active woman of a childbearing age;
- •VII.be able to speak, read, write, and understand their national language;
- •VIII.have been on stable pre-existing pharmacological or psychotherapy regimens for 4 weeks prior to study entry (to mitigate the risk of induction of mania all participants will also need to be on an accepted mood stabiliser);
- •IX.Participants will be required to nominate a current treating physician prior to randomization.
- •; I.Aged 18-65 years;
- •II.Have a DSM-V diagnosis of bipolar disorder I or II, or bipolar disorder not elsewhere classified (NEC);
- •III.Currently be in a major depressive episode on Structured Clinical Interview for DSM Disorders (SCID-5-RV);
- •IV.Score greater than or equal to 20 on the Montgomery Åsberg Depression Rating Scale (MADRS);
- •V.have the capacity to consent to the study and to follow its instructions and procedures;
- •VI.be using effective contraception if a sexually active woman of a childbearing age;
- •VII.be able to speak, read, write, and understand their national language;
- •VIII.have been on stable pre-existing pharmacological or psychotherapy regimens for 4 weeks prior to study entry (to mitigate the risk of induction of mania all participants will also need to be on an accepted mood stabiliser);
- •IX.Participants will be required to nominate a current treating physician prior to randomization.
排除标准
- •I.have a known or suspected active systemic medical disorder;
- •II.have a primary clinical diagnosis of another disorder such as borderline personality disorder, assessed using the SCID-5-RV;
- •III.have a diagnosis of another psychotic disorder and/or current substance use disorder, assessed using the SCID-5-RV;
- •IV.be undergoing electroconvulsive or transcranial magnetic stimulation therapy;
- •V.have contraindications or intolerance or allergy to trimetazidine or any of the trial preparations;
- •VI.have a concurrent enrolment in another psychiatric clinical trial;
- •VII.are pregnant or lactating (participants will be requested to conduct a urine pregnancy test if sexually active and of child-bearing age);
- •VIII.Inability to comply with either the requirements of informed consent or the treatment protocol;
- •IX.Any history of renal disease/impairment, Parkinson’s disease, restless legs syndrome or other movement disorders.
- •; I.have a known or suspected active systemic medical disorder;
- •II.have a primary clinical diagnosis of another disorder such as borderline personality disorder, assessed using the SCID-5-RV;
- •III.have a diagnosis of another psychotic disorder and/or current substance use disorder, assessed using the SCID-5-RV;
- •IV.be undergoing electroconvulsive or transcranial magnetic stimulation therapy;
- •V.have contraindications or intolerance or allergy to trimetazidine or any of the trial preparations;
- •VI.have a concurrent enrolment in another psychiatric clinical trial;
- •VII.are pregnant or lactating (participants will be requested to conduct a urine pregnancy test if sexually active and of child-bearing age);
- •VIII.Inability to comply with either the requirements of informed consent or the treatment protocol;
- •IX.Any history of renal disease/impairment, Parkinson’s disease, restless legs syndrome or other movement disorders.
研究者
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