drugset / Trial / NCT01197846

Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder

NCT01197846

RandomizedParallel-groupDouble-blindTreatment

Summary

Pilot multicentric, prospective, placebo controlled, randomized double blinded, study of 12 weeks follow-up Adult patients diagnosed of bipolar disorder I or II, in previous treatment with no more than two concomitant mood stabilizers at stable doses and current subsyndromal symptoms, defined as YMRS ≤14 and/ or MADRS≥8 and ≤14 would be included Sub-acute phases would be excluded (at least 8 weeks from last exacerbation would be required for inclusion).

Timeline

Start
2010-09
Primary completion
2012-02
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Quetiapine Small molecule 300 mg
Subject Quetiapine Small molecule 600 mg

Indications