Clinical trial NCT00622245: Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active Referenced Study of Lu AA34893 to Evaluate the Efficacy and Safety of Three Doses Lu AA34893 in the Treatment of Depression in Patients With Bipolar I or II Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Depression in Patients With Bipolar Disorder
Keywords: Depression
Bipolar disorder
Placebo-controlled
Double-blind
Multicenter
Clinical study
Mania
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 166
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 different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

Detailed description: Bipolar disorder is a common lifelong psychiatric disorder. It is 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 medical need for the patient is to remain symptom-free for as long a period as possible. A reduction both in severity of depression and mania, and in frequency of cycling, is the aim.

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 AA34893, in treatment of depression in patients with bipolar disorder.

Eligibility criteria: Inclusion Criteria:

* Current major depressive episode of bipolar I or bipolar II 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: HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examinations
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: AU001
city: Dandenong
country: Australia
facility: AU003
city: Malvern
country: Australia
facility: AU002
city: Vienna
country: Austria
facility: AT002
city: Vienna
country: Austria
facility: AT001
city: Vienna
country: Austria
facility: AT003
city: Bruxelles
country: Belgium
facility: BE004
city: Charleroi
country: Belgium
facility: BE003
city: Diest
country: Belgium
facility: BE002
city: Stara Zagora
country: Bulgaria
facility: BG004
city: London
country: Canada
facility: CA303
city: Montreal
country: Canada
facility: CA301
city: Orleans
country: Canada
facility: CA302
city: Clermont-Ferrand Cedex 1
country: France
facility: FR001
city: Orvault
country: France
facility: FR007
city: Paris
country: France
facility: FR004
city: Sartrouville
country: France
facility: FR002
city: Berlin
country: Germany
facility: DE004
city: Bochum
country: Germany
facility: DE003
city: Gelsenkirchen
country: Germany
facility: DE002
city: Inchon
country: Korea, Republic of
facility: KR004
city: Jeonju
country: Korea, Republic of
facility: KR003
city: Kyunggi-do
country: Korea, Republic of
facility: KR005
city: Seoul
country: Korea, Republic of
facility: KR002
city: Kaunas region
country: Lithuania
facility: LT003
city: Kaunas
country: Lithuania
facility: LT005
city: Klaipeda
country: Lithuania
facility: LT004
city: Vilnius
country: Lithuania
facility: LT001
city: Vilnius
country: Lithuania
facility: LT002
city: Klang
country: Malaysia
facility: MY004
city: Kota Kinabalu
country: Malaysia
facility: MY005
city: Kuala Lumpur
country: Malaysia
facility: MY002
city: Las Piñas
country: Philippines
facility: PH002
city: Mandaluyong City
country: Philippines
facility: PH003
city: Mandaue City
country: Philippines
facility: PH001
city: Gdansk
country: Poland
facility: PL002
city: Arad
country: Romania
facility: RO001
city: Bucharest
country: Romania
facility: RO002
city: Cluj
country: Romania
facility: RO003
city: Craiova
country: Romania
facility: RO005
city: Bratislava
country: Slovakia
facility: SK001
city: Presov
country: Slovakia
facility: SK002
city: Halmstad
country: Sweden
facility: SE006
city: Lund
country: Sweden
facility: SE003
city: Malmo
country: Sweden
facility: SE005
city: Sollentuna
country: Sweden
facility: SE002
city: Stockholm
country: Sweden
facility: SE001
city: Taichung
country: Taiwan
facility: TW002
city: Lviv
country: Ukraine
facility: UA003
city: Oxford
country: United Kingdom
facility: GB001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: