ISRCTN17054996已完成未知
Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in people with bipolar depression
niversity of Oxford (UK)0 个研究点目标入组 202 人开始时间: 2008年2月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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
入排标准
- 性别
- All
入选标准
- •For the active run-in phase:
- •1. Primary diagnosis of bipolar disorder type I or II (based on Diagnostic and Statistical Manual of Mental Disorders, 4th edition [DSM-IV] criteria for a hypomanic or manic episode)
- •2. Consent to participate in the trial
- •3. Aged 16 or over
- •4. Current depressive episode requiring new pharmacological treatment (either as add-on therapy or as a change of treatment)
- •5. Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) Score >= 14
- •Please note that, as of 15/09/2008, inclusion criterion 1. Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) bipolar disorder type I or II (assessed using the Mini-International Neuropsychiatric Interview [MINI]) has been replaced with 1. Primary diagnosis of bipolar disorder type I or II (based on Diagnostic and Statistical Manual of Mental Disorders, 4th edition [DSM-IV] criteria for a hypomanic or manic episode)
- •For the randomised phase:
- •1. Able to tolerate quetiapine at a dose of at least 150 mg/day
- •2. Uncertainty whether quetiapine plus lamotrigine would be more effective than quetiapine monotherapy
- •3. Acceptable adherence to quetiapine (>90%) and to self-report SMS text-messages satisfactory
- •4. QIDS-SR16 score of >=11 on day of randomisation
- •5. Willing to accept random allocation of treatments
- •6. In the opinion of the investigator, not currently experiencing manic or mixed episode
排除标准
- •Current exclusion criteria as of 15/09/2008:
- •1. Definite indications or contraindications to lamotrigine, quetiapine or folic acid (Including pregnancy or 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. Primary diagnosis of schizophrenia
- •Plus, for women of child-bearing potential:
- •5. Currently breast feeding or not using adequate contraception
- •Current exclusion criteria as of 28/04/2008:
- •1. Definite indications or contraindications to lamotrigine, quetiapine or folic acid (Including pregnancy or 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 meeting criteria for (hypo)mania (based on MINI)
- •5. Currently meeting criteria for schizophrenia
- •6. Eight or more mood episodes in the past year
- •Plus, for women of child-bearing potential:
- •7. Not using adequate contraception
- •Initial exclusion criteria:
- •1. Definite indications or contraindications to lamotrigine, quetiapine or folic acid (Including pregnancy or planned pregnancy)
- •2. New course of structured psychotherapy started in the past four weeks
- •3. First appointment for structured psychotherapy booked within the next 14 weeks
- •4. Currently meeting criteria for (hypo)mania (based on MINI)
- •5. Eight or more mood episodes in the past year
- •Plus, for women of child-bearing potential:
- •6. Not using adequate contraception
研究者
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