Clinical trial NCT00771134: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bipolar Disorder
Keywords: Depression
Bipolar I Disorder
Bipolar II Disorder
Placebo-controlled
Double-blind
Randomised controlled
Multicenter
Clinical study
Mania
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Depressive symptoms as measured by the change from baseline in total MADRS score
timeFrame: 8 weeks
Secondary outcomes:
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
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: US024
state: Georgia
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: