EUCTR2007-004513-33-GB进行中（未招募）1 期
Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in patients with bipolar depression - CEQUE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 202
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
入选标准
- •For randomisation:
- •1. primary diagnosis of DSM-IV bipolar disorder type I or II
- •2. consent to randomisation
- •3. aged 16 or over
- •4. current depressive episode requiring new pharmacological treatment
- •5. Quick Inventory of Depressive Symptomatology, self-report version (QIDS-SR16) score at least 11
- •6. uncertainty whether quetiapine plus lamotrigine would be more effective than quetiapine monotherapy
- •7. ability to tolerate quetiapine at a dose of at least 150mg/day
- •8. acceptable adherence to quetiapine (>90%) and self-report SMS satisfactory
- •9. Willing to accepr random allocation of treatments
- •10. in the opinion of the investigator, not currently experiencing manic or mixed episode.
- •Are the trial subjects under 18? yes
- •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
- •For randomisation:
- •1. definite indications or contraindications to lamotrigine, quetiapine or folic acid* (including pregnancy and planned pregnancy)
- •2. new course of specific psychosocial intervention started in the past four weeks
- •3. first appointment for specific psychosocial intervention booked within the next 14 weeks
- •4. currently experiencing manic or mixed episode
- •5. primary diagnosis of schizophrenia
- •Plus, for women of child-bearing potential
- •6.not using adequate contraception or currently breast feeding.
- •* if contraindications are to folic acid/placebo only the person can enter the trial and be randomly allocated lamotrigine/placebo but not folic acid/placebo.
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