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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00622245




Registration number
NCT00622245
Ethics application status
Date submitted
12/02/2008
Date registered
22/02/2008
Date last updated
27/09/2010

Titles & IDs
Public title
Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
Scientific 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
Secondary ID [1] 0 0
2007-002551-17
Secondary ID [2] 0 0
12022A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression in Patients With Bipolar Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lu AA34893
Treatment: Drugs - Quetiapine fumarate
Treatment: Drugs - Placebo

Experimental: Lu AA34893: 4 mg -

Experimental: Lu AA34893: 12 mg -

Experimental: Lu AA34893: 18 mg -

Other: Quetiapine fumarate - Active reference 300 mg

Placebo comparator: Placebo -


Treatment: Drugs: Lu AA34893
per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period

Treatment: Drugs: Quetiapine fumarate
per oral, once daily, during 12 weeks, followed by a one-week tapering period

Treatment: Drugs: Placebo
per oral doses, twice daily as capsules during 13 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Depressive symptoms as measured by the change from baseline in total MADRS score
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examinations
Timepoint [1] 0 0
12 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AU001 - Brisbane
Recruitment hospital [2] 0 0
AU003 - Dandenong
Recruitment hospital [3] 0 0
AU002 - Malvern
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment postcode(s) [2] 0 0
3175 - Dandenong
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Charleroi
Country [4] 0 0
Belgium
State/province [4] 0 0
Diest
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Stara Zagora
Country [6] 0 0
Canada
State/province [6] 0 0
London
Country [7] 0 0
Canada
State/province [7] 0 0
Montreal
Country [8] 0 0
Canada
State/province [8] 0 0
Orleans
Country [9] 0 0
France
State/province [9] 0 0
Clermont-Ferrand Cedex 1
Country [10] 0 0
France
State/province [10] 0 0
Orvault
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
France
State/province [12] 0 0
Sartrouville
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Bochum
Country [15] 0 0
Germany
State/province [15] 0 0
Gelsenkirchen
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Inchon
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Jeonju
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Kyunggi-do
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Lithuania
State/province [20] 0 0
Kaunas region
Country [21] 0 0
Lithuania
State/province [21] 0 0
Kaunas
Country [22] 0 0
Lithuania
State/province [22] 0 0
Klaipeda
Country [23] 0 0
Lithuania
State/province [23] 0 0
Vilnius
Country [24] 0 0
Malaysia
State/province [24] 0 0
Klang
Country [25] 0 0
Malaysia
State/province [25] 0 0
Kota Kinabalu
Country [26] 0 0
Malaysia
State/province [26] 0 0
Kuala Lumpur
Country [27] 0 0
Philippines
State/province [27] 0 0
Las Piñas
Country [28] 0 0
Philippines
State/province [28] 0 0
Mandaluyong City
Country [29] 0 0
Philippines
State/province [29] 0 0
Mandaue City
Country [30] 0 0
Poland
State/province [30] 0 0
Gdansk
Country [31] 0 0
Romania
State/province [31] 0 0
Arad
Country [32] 0 0
Romania
State/province [32] 0 0
Bucharest
Country [33] 0 0
Romania
State/province [33] 0 0
Cluj
Country [34] 0 0
Romania
State/province [34] 0 0
Craiova
Country [35] 0 0
Slovakia
State/province [35] 0 0
Bratislava
Country [36] 0 0
Slovakia
State/province [36] 0 0
Presov
Country [37] 0 0
Sweden
State/province [37] 0 0
Halmstad
Country [38] 0 0
Sweden
State/province [38] 0 0
Lund
Country [39] 0 0
Sweden
State/province [39] 0 0
Malmo
Country [40] 0 0
Sweden
State/province [40] 0 0
Sollentuna
Country [41] 0 0
Sweden
State/province [41] 0 0
Stockholm
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Ukraine
State/province [43] 0 0
Lviv
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
H. Lundbeck A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00622245