BALANCE 2: Bipolar disorder:Antidepressant/Lamotrigine/ANtipsychotic Comparative Evaluation - BALANCE 2

niversity of Oxford0 个研究点目标入组 630 人开始时间: 2006年4月11日最近更新: 2019年6月30日

试验速览

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•1. Diagnosis of DSM-IV bipolar I, II or spectrum disorder
•2, Current depressive episode requiring new pharmacological treatment (change of SSRI or addition of a new SSRI would constitute new treatment but an increase in the dose of a current SSRI would not).
•3. Uncertainty whether SSRI, quetiapine or lamotrigine would be safer and more effective in the short and medium term
•4. Consent to randomization
•5. Aged 16 or over
•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

•1. Contraindication to SSRIs
•2. Contraindication to lamotrigine
•3. Contraindication to quetiapine
•4. Ongoing treatment or treatment for this episode with lamotrigine or quetiapine
•5. Eight or more mood episodes in the past year
•6. For patients with bipolar I disorder, unwillingness to take adjunctive therapy
•7. Evidence of poor adherence to prescribed medicines

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