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Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

This study has been terminated.
(Study was previously suspended and is now terminated)
ClinicalTrials.gov Identifier:
First Posted: October 13, 2008
Last Update Posted: May 28, 2014
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.
Information provided by (Responsible Party):
H. Lundbeck A/S
October 10, 2008
October 13, 2008
May 28, 2014
December 2008
June 2009   (Final data collection date for primary outcome measure)
Depressive symptoms as measured by the change from baseline in total MADRS score [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT00771134 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression
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
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Lu AA39959
    30mg/day; 15mg B.I.D. for 8 weeks
  • Drug: Placebo
    B.I.D. for 8 weeks
  • Drug: Quetiapine
    300mg/day for 8 weeks
    Other Name: Seroquel
  • Experimental: Lu AA39959
    Intervention: Drug: Lu AA39959
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Quetiapine
    Intervention: Drug: Quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP