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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)
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00771134
First received: October 10, 2008
Last updated: May 14, 2014
Last verified: May 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ]

Enrollment: 105
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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, see Learn About Clinical Studies.

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

Locations
United States, Georgia
US024
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
ClinicalTrials.gov Identifier: NCT00771134     History of Changes
Other Study ID Numbers: 12601A
Study First Received: October 10, 2008
Last Updated: May 14, 2014
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

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Disease
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014