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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00622245

Enrollment

166

Registered

2008-02-22

Start date

2008-01-31

Completion date

2009-11-30

Last updated

2010-09-27

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

Conditions

Depression in Patients With Bipolar Disorder

Keywords

Depression, Bipolar disorder, Placebo-controlled, Double-blind, Multicenter, Clinical study, Mania

Brief 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.

Interventions

DRUGLu AA34893

per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period

DRUGQuetiapine fumarate

per oral, once daily, during 12 weeks, followed by a one-week tapering period

DRUGPlacebo

per oral doses, twice daily as capsules during 13 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

* Current major depressive episode of bipolar I or bipolar II 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
HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examinations	12 weeks

Countries

Australia, Austria, Belgium, Bulgaria, Canada, France, Germany, Lithuania, Malaysia, Philippines, Poland, Romania, Slovakia, South Korea, Sweden, Taiwan, Ukraine, United Kingdom

Outcome results

None listed

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