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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00771134

Enrollment

105

Registered

2008-10-13

Start date

2008-12-31

Completion date

2009-08-31

Last updated

2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Depression, Bipolar I Disorder, Bipolar II Disorder, Placebo-controlled, Double-blind, Randomised controlled, Multicenter, Clinical study, Mania

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.

Interventions

DRUGLu AA39959

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

DRUGPlacebo

B.I.D. for 8 weeks

DRUGQuetiapine

300mg/day for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026