EUCTR2006-001317-15-GB
Active, not recruiting
Phase 1
BALANCE 2: Bipolar disorder:Antidepressant/Lamotrigine/ANtipsychotic Comparative Evaluation - BALANCE 2
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Oxford
- Enrollment
- 630
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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