Expired Study
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Atlanta, Georgia 30308


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

12601A


NCT ID:

NCT00771134


Secondary ID:


Study Acronym:


Brief Title:

Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression


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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

H. Lundbeck A/S


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Study was previously suspended and is now te


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

105


Enrollment Type:

Actual


Overall Contact Information

Official Name:Email contact via H. Lundbeck A/S
Study Director
LundbeckClinicalTrials@lundbeck.com

Study Dates

Start Date:December 2008
Completion Date:August 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:February 2014
Last Changed Date:February 24, 2014
First Received Date:October 10, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Depressive symptoms as measured by the change from baseline in total MADRS score
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Lu AA39959
Description:30mg/day; 15mg B.I.D. for 8 weeks
Arm Name:Lu AA39959
Intervention Type:Drug
Name:Placebo
Description:B.I.D. for 8 weeks
Arm Name:Placebo
Intervention Type:Drug
Name:Quetiapine
Description:300mg/day for 8 weeks
Arm Name:Quetiapine
Other Name:Seroquel

Study Arms

Study Arm Type:Active Comparator
Arm Name:Quetiapine
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Experimental
Arm Name:Lu AA39959

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:H. Lundbeck A/S

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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