NCT00622245

Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active Referenced Study of Lu AA34893 to Evaluate the Efficacy and Safety of Three Doses Lu AA34893 in the Treatment of Depression in Patients With Bipolar I or II Disorder

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (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 different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

Detailed description

Bipolar disorder is a common lifelong psychiatric disorder. It is 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 medical need for the patient is to remain symptom-free for as long a period as possible. A reduction both in severity of depression and mania, and in frequency of cycling, is the aim. 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 AA34893, in treatment of depression in patients with bipolar disorder.

Conditions

• Depression in Patients With Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Lu AA34893	per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
DRUG	Quetiapine fumarate	per oral, once daily, during 12 weeks, followed by a one-week tapering period
DRUG	Placebo	per oral doses, twice daily as capsules during 13 weeks

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-01-01
• Completion: 2009-11-01
• First posted: 2008-02-22
• Last updated: 2010-09-27

Locations

50 sites across 18 countries: Australia, Austria, Belgium, Bulgaria, Canada, France, Germany, Lithuania, Malaysia, Philippines, Poland, Romania, Slovakia, South Korea, Sweden, Taiwan, Ukraine, United Kingdom