BALANCE 2: Bipolar disorder:Antidepressant/Lamotrigine/ANtipsychotic Comparative Evaluation - BALANCE 2
- Conditions
- Bipolar depression.
- Registration Number
- EUCTR2006-001317-15-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 630
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method