Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

This study has been terminated.
(Human metabolite not yet covered sufficiently by nonclinical data)
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00622245
First received: February 12, 2008
Last updated: September 24, 2010
Last verified: September 2010
  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 2

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

Resource links provided by NLM:


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 examinations [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 166
Study Start Date: January 2008
Study Completion Date: November 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AA34893: 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
Experimental: Lu AA34893: 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
Experimental: Lu AA34893: 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
Quetiapine fumarate
Active reference 300 mg
Drug: Quetiapine fumarate
per oral, once daily, during 12 weeks, followed by a one-week tapering period
Placebo Comparator: Placebo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00622245     History of Changes
Other Study ID Numbers: 12022A, 2007-002551-17
Study First Received: February 12, 2008
Last Updated: September 24, 2010
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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Pathologic Processes
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2014