Study Stopped
Study was previously suspended and is now terminated
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
1 other identifier
interventional
105
1 country
1
Brief Summary
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedMay 28, 2014
May 1, 2014
6 months
October 10, 2008
May 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depressive symptoms as measured by the change from baseline in total MADRS score
8 weeks
Secondary Outcomes (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
8 weeks
Study Arms (3)
Lu AA39959
EXPERIMENTALPlacebo
PLACEBO COMPARATORQuetiapine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
US024
Atlanta, Georgia, 30308, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2008
First Posted
October 13, 2008
Study Start
December 1, 2008
Primary Completion
June 1, 2009
Study Completion
August 1, 2009
Last Updated
May 28, 2014
Record last verified: 2014-05