Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

Phase 2TerminatedNCT00771134

H. Lundbeck A/S105 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

105

Conditions

Bipolar Disorder

Interventions

Lu AA39959DRUG

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

PlaceboDRUG

B.I.D. for 8 weeks

QuetiapineDRUG

300mg/day for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Patients suffering from a major depressive episode of bipolar II or I disorder, according to DSM-IV TR 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

Locations (1)

US024

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Depressive symptoms as measured by the change from baseline in total MADRS score

Time frame: 8 weeks

Secondary Outcomes

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

Time frame: 8 weeks

Data from ClinicalTrials.gov

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