Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

NCT ID: NCT00771134

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-08-31

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lu AA39959

Group Type: EXPERIMENTAL

Lu AA39959

Intervention Type: DRUG

30mg/day; 15mg B.I.D. for 8 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

B.I.D. for 8 weeks

Quetiapine

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

300mg/day for 8 weeks

Interventions

Lu AA39959

30mg/day; 15mg B.I.D. for 8 weeks

Intervention Type: DRUG

Placebo

B.I.D. for 8 weeks

Intervention Type: DRUG

Quetiapine

300mg/day for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Seroquel

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

US024

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

12601A

Identifier Type: -

Identifier Source: org_study_id