NCT00771134

Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Quetiapine-Referenced, Fixed-Dose Study of Lu AA39959 in the Treatment of Depression in Patients With Bipolar I or II Disorder

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.

Detailed description

Bipolar disorder is a common lifelong psychiatric disorder characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. Patients spend more time in depression than in (hypo)mania over their life time. The main goals for the treatment of bipolar disorder are resolution of symptoms, return to premorbid level of social functioning and prevention of future episodes. Although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. Recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. There is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. This study evaluates the efficacy and safety of the new drug, Lu AA39959, in treatment of depression in patients with bipolar disorder.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Lu AA39959	30mg/day; 15mg B.I.D. for 8 weeks
DRUG	Placebo	B.I.D. for 8 weeks
DRUG	Quetiapine	300mg/day for 8 weeks

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2008-10-13
• Last updated: 2014-05-28

Locations

1 site across 1 country: United States