Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

Phase 2TerminatedNCT00622245

H. Lundbeck A/S166 enrolled

Overview

This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

166

Conditions

Depression in Patients With Bipolar Disorder

Interventions

Lu AA34893DRUG

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

Quetiapine fumarateDRUG

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

PlaceboDRUG

per oral doses, twice daily as capsules during 13 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 exclusion criteria may apply

Locations (50)

Outcomes

Primary Outcomes

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

Time frame: 8 weeks

Secondary Outcomes

HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examinations

Time frame: 12 weeks

Data from ClinicalTrials.gov

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AU001

Brisbane, Australia

AU003

Dandenong, Australia

AU002

Malvern, Australia

AT002

Vienna, Austria

AT001

Vienna, Austria

AT003

Vienna, Austria

BE004

Brussels, Belgium

BE003

Charleroi, Belgium

BE002

Diest, Belgium

BG004

Stara Zagora, Bulgaria

...and 40 more locations