Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

Phase 2

Terminated

• Conditions: Depression in Patients With Bipolar Disorder
• Interventions: Drug: Lu AA34893; Drug: Quetiapine fumarate; Drug: Placebo

• Registration Number: NCT00622245
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-22
• Primary Completion: 2009-01
• Study Completion: 2009-11
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-24
• Last Update Posted: 2010-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lu AA34893: 4 mg	Lu AA34893	-
Lu AA34893: 12 mg	Lu AA34893	-
Lu AA34893: 18 mg	Lu AA34893	-
Quetiapine fumarate	Quetiapine fumarate	Active reference 300 mg
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (50)

AU001; 🇦🇺 Brisbane, Australia

AU003; 🇦🇺 Dandenong, Australia

AU002; 🇦🇺 Malvern, Australia

AT002; 🇦🇹 Vienna, Austria

AT001; 🇦🇹 Vienna, Austria

AT003; 🇦🇹 Vienna, Austria

BE004; 🇧🇪 Bruxelles, Belgium

BE003; 🇧🇪 Charleroi, Belgium

BE002; 🇧🇪 Diest, Belgium

BG004; 🇧🇬 Stara Zagora, Bulgaria

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