Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00622245
• Date of registration: 12/02/2008
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
• Scientific title: 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
• Date of first enrolment: January 2008
• Target sample size: 166
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00622245
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression in Patients With Bipolar Disorder

Intervention(s)

Drug: Lu AA34893

Drug: Placebo

Drug: Quetiapine fumarate

Primary Outcome(s)

Depressive symptoms as measured by the change from baseline in total MADRS score [Time Frame: 8 weeks]

Secondary Outcome(s)

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]

Secondary ID(s)

2007-002551-17

12022A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors