Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

Depression in Patients With Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00622245
• Other study ID #: 12022A
• Secondary ID: 2007-002551-17
• Status: Terminated
• Phase: Phase 2
• First received: February 12, 2008
• Last updated: September 24, 2010
• Start date: January 2008
• Est. completion date: November 2009

Study information

• Verified date: September 2010
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFrance: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesLithuania: State Medicine Control Agency - Ministry of HealthMalaysia: Ministry of HealthPhilippines: Bureau of Food and DrugsRomania: National Medicines AgencySlovakia: State Institute for Drug ControlSouth Korea: Korea Food and Drug Administration (KFDA)Sweden: Medical Products AgencyTaiwan: National Bureau of Controlled DrugsUkraine: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 166
• Est. completion date: November 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression in Patients With Bipolar Disorder
• Depressive Disorder

Intervention

Drug:
• Lu AA34893
per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
• Quetiapine fumarate
per oral, once daily, during 12 weeks, followed by a one-week tapering period
• Placebo
per oral doses, twice daily as capsules during 13 weeks

Locations

Country	Name	City	State
Australia	AU001	Brisbane
Australia	AU003	Dandenong
Australia	AU002	Malvern
Austria	AT001	Vienna
Austria	AT002	Vienna
Austria	AT003	Vienna
Belgium	BE004	Bruxelles
Belgium	BE003	Charleroi
Belgium	BE002	Diest
Bulgaria	BG004	Stara Zagora
Canada	CA303	London
Canada	CA301	Montreal
Canada	CA302	Orleans
France	FR001	Clermont-Ferrand Cedex 1
France	FR007	Orvault
France	FR004	Paris
France	FR002	Sartrouville
Germany	DE004	Berlin
Germany	DE003	Bochum
Germany	DE002	Gelsenkirchen
Korea, Republic of	KR004	Inchon
Korea, Republic of	KR003	Jeonju
Korea, Republic of	KR005	Kyunggi-do
Korea, Republic of	KR002	Seoul
Lithuania	LT005	Kaunas
Lithuania	LT003	Kaunas region
Lithuania	LT004	Klaipeda
Lithuania	LT001	Vilnius
Lithuania	LT002	Vilnius
Malaysia	MY004	Klang
Malaysia	MY005	Kota Kinabalu
Malaysia	MY002	Kuala Lumpur
Philippines	PH002	Las Piñas
Philippines	PH003	Mandaluyong City
Philippines	PH001	Mandaue City
Poland	PL002	Gdansk
Romania	RO001	Arad
Romania	RO002	Bucharest
Romania	RO003	Cluj
Romania	RO005	Craiova
Slovakia	SK001	Bratislava
Slovakia	SK002	Presov
Sweden	SE006	Halmstad
Sweden	SE003	Lund
Sweden	SE005	Malmo
Sweden	SE002	Sollentuna
Sweden	SE001	Stockholm
Taiwan	TW002	Taichung
Ukraine	UA003	Lviv
United Kingdom	GB001	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Bulgaria,  Canada,  France,  Germany,  Korea, Republic of,  Lithuania,  Malaysia,  Philippines,  Poland,  Romania,  Slovakia,  Sweden,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms as measured by the change from baseline in total MADRS score		8 weeks	No
Secondary	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	Yes