Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

September 24, 2010 updated by: H. Lundbeck A/S

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia, 4000
        • AU001
      • Dandenong, Australia, 3175
        • AU003
      • Malvern, Australia, 3144
        • AU002
  • Austria
      • Vienna, Austria, 1090
        • AT001
      • Vienna, Austria, 1010
        • AT002
      • Vienna, Austria, 1090
        • AT003
  • Belgium
      • Bruxelles, Belgium, 1180
        • BE004
      • Charleroi, Belgium, 6000
        • BE003
      • Diest, Belgium, 3290
        • BE002
  • Bulgaria
      • Stara Zagora, Bulgaria, 6000
        • BG004
  • Canada
      • London, Canada, N6A 4H1
        • CA303
      • Montreal, Canada, H3M 3A9
        • CA301
      • Orleans, Canada, K1C 1E9
        • CA302
  • France
      • Clermont-Ferrand Cedex 1, France, 63003
        • FR001
      • Orvault, France, 44700
        • FR007
      • Paris, France, 75571
        • FR004
      • Sartrouville, France, 78500
        • FR002
  • Germany
      • Berlin, Germany, 10245
        • DE004
      • Bochum, Germany, 44892
        • DE003
      • Gelsenkirchen, Germany, 45879
        • DE002
  • Korea, Republic of
      • Inchon, Korea, Republic of, 403-720
        • KR004
      • Jeonju, Korea, Republic of, 561-712
        • KR003
      • Kyunggi-do, Korea, Republic of, 431-720
        • KR005
      • Seoul, Korea, Republic of, 110-744
        • KR002
  • Lithuania
      • Kaunas, Lithuania, 50185
        • LT005
      • Kaunas region, Lithuania, 53136
        • LT003
      • Klaipeda, Lithuania, 91251
        • LT004
      • Vilnius, Lithuania, 10204
        • LT001
      • Vilnius, Lithuania, 10204
        • LT002
  • Malaysia
      • Klang, Malaysia, 43000
        • MY004
      • Kota Kinabalu, Malaysia, 88815
        • MY005
      • Kuala Lumpur, Malaysia, 59100
        • MY002
  • Philippines
      • Las Piñas, Philippines, 1701
        • PH002
      • Mandaluyong City, Philippines
        • PH003
      • Mandaue City, Philippines, 6014
        • PH001
  • Poland
      • Gdansk, Poland, 80-211
        • PL002
  • Romania
      • Arad, Romania, 310022
        • RO001
      • Bucharest, Romania, 41914
        • RO002
      • Cluj, Romania, 400012
        • RO003
      • Craiova, Romania, 200260
        • RO005
  • Slovakia
      • Bratislava, Slovakia, 82007
        • SK001
      • Presov, Slovakia, 081 81
        • SK002
  • Sweden
      • Halmstad, Sweden, 302 27
        • SE006
      • Lund, Sweden, 223 61
        • SE003
      • Malmo, Sweden, 211 22
        • SE005
      • Sollentuna, Sweden, 191 35
        • SE002
      • Stockholm, Sweden, 112 34
        • SE001
  • Taiwan
      • Taichung, Taiwan, 404
        • TW002
  • Ukraine
      • Lviv, Ukraine, 79021
        • UA003
  • United Kingdom
      • Oxford, United Kingdom, OX3 7JX
        • GB001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
per oral doses, twice daily as capsules during 13 weeks
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
Other: Quetiapine fumarate
Active reference 300 mg
Drug: Quetiapine fumarate
per oral, once daily, during 12 weeks, followed by a one-week tapering period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depressive symptoms as measured by the change from baseline in total MADRS score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

September 27, 2010

Last Update Submitted That Met QC Criteria

September 24, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12022A
  • 2007-002551-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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