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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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
This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the
treatment of depression in patients with bipolar disorder.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00622245
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
LundbeckClinicalTrials@lundbeck.com
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00622245