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Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

Primary Purpose

Depression in Patients With Bipolar Disorder

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lu AA34893
Quetiapine fumarate
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Patients With Bipolar Disorder focused on measuring Depression, Bipolar disorder, Placebo-controlled, Double-blind, Multicenter, Clinical study, Mania

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AU001
  • AU003
  • AU002
  • AT002
  • AT001
  • AT003
  • BE004
  • BE003
  • BE002
  • BG004
  • CA303
  • CA301
  • CA302
  • FR001
  • FR007
  • FR004
  • FR002
  • DE004
  • DE003
  • DE002
  • KR004
  • KR003
  • KR005
  • KR002
  • LT003
  • LT005
  • LT004
  • LT001
  • LT002
  • MY004
  • MY005
  • MY002
  • PH002
  • PH003
  • PH001
  • PL002
  • RO001
  • RO002
  • RO003
  • RO005
  • SK001
  • SK002
  • SE006
  • SE003
  • SE005
  • SE002
  • SE001
  • TW002
  • UA003
  • GB001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Other

Placebo Comparator

Arm Label

Lu AA34893: 4 mg

Lu AA34893: 12 mg

Lu AA34893: 18 mg

Quetiapine fumarate

Placebo

Arm Description

Active reference 300 mg

Outcomes

Primary Outcome Measures

Depressive symptoms as measured by the change from baseline in total MADRS score

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

Full Information

First Posted
February 12, 2008
Last Updated
September 24, 2010
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00622245
Brief Title
Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Why Stopped
Human metabolite not yet covered sufficiently by nonclinical data
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Patients With Bipolar Disorder
Keywords
Depression, Bipolar disorder, Placebo-controlled, Double-blind, Multicenter, Clinical study, Mania

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lu AA34893: 4 mg
Arm Type
Experimental
Arm Title
Lu AA34893: 12 mg
Arm Type
Experimental
Arm Title
Lu AA34893: 18 mg
Arm Type
Experimental
Arm Title
Quetiapine fumarate
Arm Type
Other
Arm Description
Active reference 300 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lu AA34893
Intervention Description
per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Intervention Description
per oral, once daily, during 12 weeks, followed by a one-week tapering period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
per oral doses, twice daily as capsules during 13 weeks
Primary Outcome Measure Information:
Title
Depressive symptoms as measured by the change from baseline in total MADRS score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
AU001
City
Brisbane
ZIP/Postal Code
4000
Country
Australia
Facility Name
AU003
City
Dandenong
ZIP/Postal Code
3175
Country
Australia
Facility Name
AU002
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Facility Name
AT002
City
Vienna
ZIP/Postal Code
1010
Country
Austria
Facility Name
AT001
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
AT003
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
BE004
City
Bruxelles
ZIP/Postal Code
1180
Country
Belgium
Facility Name
BE003
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
BE002
City
Diest
ZIP/Postal Code
3290
Country
Belgium
Facility Name
BG004
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
CA303
City
London
ZIP/Postal Code
N6A 4H1
Country
Canada
Facility Name
CA301
City
Montreal
ZIP/Postal Code
H3M 3A9
Country
Canada
Facility Name
CA302
City
Orleans
ZIP/Postal Code
K1C 1E9
Country
Canada
Facility Name
FR001
City
Clermont-Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
FR007
City
Orvault
ZIP/Postal Code
44700
Country
France
Facility Name
FR004
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
FR002
City
Sartrouville
ZIP/Postal Code
78500
Country
France
Facility Name
DE004
City
Berlin
ZIP/Postal Code
10245
Country
Germany
Facility Name
DE003
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
DE002
City
Gelsenkirchen
ZIP/Postal Code
45879
Country
Germany
Facility Name
KR004
City
Inchon
ZIP/Postal Code
403-720
Country
Korea, Republic of
Facility Name
KR003
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
KR005
City
Kyunggi-do
ZIP/Postal Code
431-720
Country
Korea, Republic of
Facility Name
KR002
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
LT003
City
Kaunas region
ZIP/Postal Code
53136
Country
Lithuania
Facility Name
LT005
City
Kaunas
ZIP/Postal Code
50185
Country
Lithuania
Facility Name
LT004
City
Klaipeda
ZIP/Postal Code
91251
Country
Lithuania
Facility Name
LT001
City
Vilnius
ZIP/Postal Code
10204
Country
Lithuania
Facility Name
LT002
City
Vilnius
ZIP/Postal Code
10204
Country
Lithuania
Facility Name
MY004
City
Klang
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
MY005
City
Kota Kinabalu
ZIP/Postal Code
88815
Country
Malaysia
Facility Name
MY002
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
PH002
City
Las Piñas
ZIP/Postal Code
1701
Country
Philippines
Facility Name
PH003
City
Mandaluyong City
Country
Philippines
Facility Name
PH001
City
Mandaue City
ZIP/Postal Code
6014
Country
Philippines
Facility Name
PL002
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
RO001
City
Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
RO002
City
Bucharest
ZIP/Postal Code
41914
Country
Romania
Facility Name
RO003
City
Cluj
ZIP/Postal Code
400012
Country
Romania
Facility Name
RO005
City
Craiova
ZIP/Postal Code
200260
Country
Romania
Facility Name
SK001
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Facility Name
SK002
City
Presov
ZIP/Postal Code
081 81
Country
Slovakia
Facility Name
SE006
City
Halmstad
ZIP/Postal Code
302 27
Country
Sweden
Facility Name
SE003
City
Lund
ZIP/Postal Code
223 61
Country
Sweden
Facility Name
SE005
City
Malmo
ZIP/Postal Code
211 22
Country
Sweden
Facility Name
SE002
City
Sollentuna
ZIP/Postal Code
191 35
Country
Sweden
Facility Name
SE001
City
Stockholm
ZIP/Postal Code
112 34
Country
Sweden
Facility Name
TW002
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
UA003
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
GB001
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom

12. IPD Sharing Statement

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Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

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