Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

Lundbeck

Status and phase: Terminated; Phase 2

Conditions: Depression in Patients With Bipolar Disorder

Treatments: Drug: Lu AA34893; Drug: Quetiapine fumarate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00622245

2007-002551-17 (EudraCT Number)

12022A

Details and patient eligibility

About

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

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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 exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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166 participants in 5 patient groups, including a placebo group

Lu AA34893: 4 mg

Experimental group

Treatment:

Drug: Lu AA34893

Lu AA34893: 12 mg

Experimental group

Treatment:

Drug: Lu AA34893

Lu AA34893: 18 mg

Experimental group

Treatment:

Drug: Lu AA34893

Quetiapine fumarate

Other group

Description:

Active reference 300 mg

Treatment:

Drug: Quetiapine fumarate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo