Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
- Conditions
- Depression in Patients With Bipolar Disorder
- Interventions
- Registration Number
- NCT00622245
- Lead Sponsor
- H. Lundbeck A/S
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 166
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lu AA34893: 4 mg Lu AA34893 - Lu AA34893: 12 mg Lu AA34893 - Lu AA34893: 18 mg Lu AA34893 - Quetiapine fumarate Quetiapine fumarate Active reference 300 mg Placebo Placebo -
- Primary Outcome Measures
Name Time Method Depressive symptoms as measured by the change from baseline in total MADRS score 8 weeks
- Secondary Outcome Measures
Name Time Method HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examinations 12 weeks
Trial Locations
- Locations (50)
BE004
🇧🇪Bruxelles, Belgium
PL002
🇵🇱Gdansk, Poland
AU001
🇦🇺Brisbane, Australia
SE001
🇸🇪Stockholm, Sweden
PH001
🇵🇭Mandaue City, Philippines
SE002
🇸🇪Sollentuna, Sweden
SK002
🇸🇰Presov, Slovakia
AT001
🇦🇹Vienna, Austria
LT002
🇱🇹Vilnius, Lithuania
LT004
🇱🇹Klaipeda, Lithuania
RO005
🇷🇴Craiova, Romania
LT001
🇱🇹Vilnius, Lithuania
MY004
🇲🇾Klang, Malaysia
MY005
🇲🇾Kota Kinabalu, Malaysia
MY002
🇲🇾Kuala Lumpur, Malaysia
SK001
🇸🇰Bratislava, Slovakia
AU003
🇦🇺Dandenong, Australia
AU002
🇦🇺Malvern, Australia
AT002
🇦🇹Vienna, Austria
AT003
🇦🇹Vienna, Austria
BE003
🇧🇪Charleroi, Belgium
BE002
🇧🇪Diest, Belgium
CA303
🇨🇦London, Canada
BG004
🇧🇬Stara Zagora, Bulgaria
CA301
🇨🇦Montreal, Canada
KR003
🇰🇷Jeonju, Korea, Republic of
CA302
🇨🇦Orleans, Canada
FR001
🇫🇷Clermont-Ferrand Cedex 1, France
FR007
🇫🇷Orvault, France
FR002
🇫🇷Sartrouville, France
FR004
🇫🇷Paris, France
DE004
🇩🇪Berlin, Germany
DE002
🇩🇪Gelsenkirchen, Germany
KR004
🇰🇷Inchon, Korea, Republic of
DE003
🇩🇪Bochum, Germany
KR005
🇰🇷Kyunggi-do, Korea, Republic of
KR002
🇰🇷Seoul, Korea, Republic of
LT003
🇱🇹Kaunas region, Lithuania
LT005
🇱🇹Kaunas, Lithuania
PH002
🇵🇭Las Piñas, Philippines
PH003
🇵🇭Mandaluyong City, Philippines
RO001
🇷🇴Arad, Romania
RO002
🇷🇴Bucharest, Romania
RO003
🇷🇴Cluj, Romania
SE006
🇸🇪Halmstad, Sweden
SE003
🇸🇪Lund, Sweden
SE005
🇸🇪Malmo, Sweden
TW002
🇨🇳Taichung, Taiwan
UA003
🇺🇦Lviv, Ukraine
GB001
🇬🇧Oxford, United Kingdom