Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
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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 |
- Depressive symptoms as measured by the change from baseline in total MADRS score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- 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 |
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
Show 50 Study Locations| 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:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms 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 May 16, 2013