Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression - Full Text View

Sponsored by:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00622245

Purpose

This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

Condition	Intervention	Phase
Depression in Patients With Bipolar Disorder	Drug: Lu AA34893 Drug: Quetiapine fumarate Drug: Placebo	Phase II

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
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

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:

Depressive symptoms as measured by the change from baseline in total MADRS score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examiniations [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 4 mg	Drug: Lu AA34893 per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
2: Experimental 12 mg	Drug: Lu AA34893 per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
3: Experimental 18 mg	Drug: Lu AA34893 per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
4 Active reference 300 mg	Drug: Quetiapine fumarate per oral, once daily, during 12 weeks, followed by a one-week tapering period
5: Placebo Comparator	Drug: Placebo per oral doses, twice daily as capsules during 13 weeks

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622245

Show 50 Study Locations

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	12022A, EudraCT: 2007-002551-17
Study First Received:	February 12, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00622245
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Lithuania: State Medicine Control Agency - Ministry of Health; Malaysia: Ministry of Health; Philippines: Bureau of Food and Drugs; Romania: National Medicines Agency; Slovakia: State Institute for Drug Control; South Korea: Korea Food and Drug Administration (KFDA); Sweden: Medical Products Agency; Taiwan: National Bureau of Controlled Drugs; Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by H. Lundbeck A/S:

Depression
Bipolar disorder
Placebo-controlled
Double-blind

Multicenter
Clinical study
Mania

Study placed in the following topic categories:

Quetiapine
Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009