Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:

Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Quetiapine-Referenced, Fixed-Dose Study of Lu AA39959 in the Treatment of Depression in Patients With Bipolar I or II Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00771134
• Other study ID #: 12601A
• Status: Terminated
• Phase: Phase 2
• First received: October 10, 2008
• Last updated: May 14, 2014
• Start date: December 2008
• Est. completion date: August 2009

Study information

• Verified date: May 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.

Description:

Bipolar disorder is a common lifelong psychiatric disorder 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 main goals for the treatment of bipolar disorder are resolution of symptoms, return to premorbid level of social functioning and prevention of future episodes.

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 AA39959, in treatment of depression in patients with bipolar disorder.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Patients suffering from a major depressive episode of bipolar II or I disorder, according to DSM-IV TR

Inclusion Criteria:

• Current major depressive episode of bipolar II or I 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Lu AA39959
30mg/day; 15mg B.I.D. for 8 weeks
• Placebo
B.I.D. for 8 weeks
• Quetiapine
300mg/day for 8 weeks

Locations

Country	Name	City	State
United States	US024	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms as measured by the change from baseline in total MADRS score		8 weeks	No
Secondary	Global impression (Clinical Global Impression; CGI-BP-Severity/Improvement), depression/anxiety symptoms (Hamilton Depression/Anxiety scale; HAM-D/A), mania symptoms (Young Mania Rating Scale; YMRS), adverse events		8 weeks	Yes