Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression - Full Text View

Sponsored by:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00771134

Purpose

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

Condition	Intervention	Phase
Bipolar Disorder	Drug: Lu AA39959 Drug: Placebo Drug: Quetiapine	Phase II

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
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

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:

Depressive symptoms as measured by the change from baseline in total MADRS score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	December 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lu AA39959 30mg/day; 15mg B.I.D. for 8 weeks
2: Placebo Comparator	Drug: Placebo B.I.D. for 8 weeks
3: Active Comparator	Drug: Quetiapine 300mg/day for 8 weeks

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771134

Contacts

Contact: Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Locations

United States, Georgia
US024	Recruiting
Atlanta, Georgia, United States, 30308

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

No publications provided

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	12601A
Study First Received:	October 10, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00771134 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by H. Lundbeck A/S:

Depression
Bipolar I Disorder
Bipolar II Disorder
Placebo-controlled
Double-blind

Randomised controlled
Multicenter
Clinical study
Mania

Study placed in the following topic categories:

Depression
Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents

Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:

Depression
Disease
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009