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Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771134
Recruitment Status : Terminated (Study was previously suspended and is now terminated)
First Posted : October 13, 2008
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lu AA39959 Drug: Placebo Drug: Quetiapine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Quetiapine

Arm Intervention/treatment
Experimental: Lu AA39959 Drug: Lu AA39959
30mg/day; 15mg B.I.D. for 8 weeks

Placebo Comparator: Placebo Drug: Placebo
B.I.D. for 8 weeks

Active Comparator: Quetiapine Drug: Quetiapine
300mg/day for 8 weeks
Other Name: Seroquel

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00771134

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United States, Georgia
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
H. Lundbeck A/S
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Study Director: Email contact via H. Lundbeck A/S

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Responsible Party: H. Lundbeck A/S Identifier: NCT00771134    
Other Study ID Numbers: 12601A
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014
Keywords provided by H. Lundbeck A/S:
Bipolar I Disorder
Bipolar II Disorder
Randomised controlled
Clinical study
Additional relevant MeSH terms:
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Bipolar Disorder
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs