Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

Phase 2

Terminated

• Conditions: Bipolar Disorder
• Interventions: Drug: Quetiapine; Drug: Lu AA39959; Drug: Placebo

• Registration Number: NCT00771134
• Lead Sponsor: H. Lundbeck A/S

Brief 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.

Study Timeline

• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Study Start: 2008-12
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Status Verified: 2014-05
• Disposition First Submitted: 2014-05-14
• Disposition First Submitted QC: 2014-05-14
• Last Update Submitted: 2014-05-14
• Disposition First Posted: 2014-05-28
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Current major depressive episode of bipolar II or I disorder, according to DSM-IV TR
• Moderate to severe depression
• History of at least one documented mania or hypomania episode
• Absence of current mania or hypomania

Exclusion Criteria

• Any current psychiatric disorder other than bipolar disorder defined in the DSM-IV TR
• Any substance disorder with the previous 6 months
• Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study
• ECT within 6 months before the study
• Female of childbearing potential and not using adequate contraception
• Other protocol-defined inclusion and exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quetiapine	Quetiapine	-
Lu AA39959	Lu AA39959	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Depressive symptoms as measured by the change from baseline in total MADRS score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Global impression (Clinical Global Impression; CGI-BP-Severity/Improvement), depression/anxiety symptoms (Hamilton Depression/Anxiety scale; HAM-D/A), mania symptoms (Young Mania Rating Scale; YMRS), adverse events	8 weeks

Trial Locations

Locations (1)

US024; 🇺🇸 Atlanta, Georgia, United States