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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00599911




Registration number
NCT00599911
Ethics application status
Date submitted
28/12/2007
Date registered
24/01/2008
Date last updated
8/11/2016

Titles & IDs
Public title
Dose-finding Study With Lu AA24530 in Major Depressive Disorder
Scientific title
Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder
Secondary ID [1] 0 0
2007-001071-11
Secondary ID [2] 0 0
11918A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lu AA24530
Treatment: Drugs - Duloxetine
Treatment: Drugs - Placebo

Experimental: Lu AA24530: 5 mg -

Experimental: Lu AA24530: 10 mg -

Experimental: Lu AA24530: 20 mg -

Active comparator: Duloxetine: 60 mg -

Placebo comparator: Placebo -


Treatment: Drugs: Lu AA24530
per oral, once daily for 6 weeks

Treatment: Drugs: Duloxetine
per oral, once daily for 6 weeks

Treatment: Drugs: Placebo
per oral, once daily for 6 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Response rate, remission rate, and safety
Timepoint [1] 0 0
6 weeks

Eligibility
Key inclusion criteria
* Major Depressive Episode that has lasted at least 3 months
* Moderate to severe depression
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 established as the principal diagnosis other than MDD as defined in the DSM-IV-TR and as assessed with the Mini-International Neuropsychiatric Interview (MINI)
* Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR
* Major Depressive Episode that has been unresponsive to two adequate courses of antidepressant treatment, each of at least 6 weeks duration
* Electroconvulsive therapy within 6 months prior to Baseline
* Ongoing formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study
* Clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
* The patient is pregnant or breast-feeding

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
652
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AU002 - Brisbane
Recruitment hospital [2] 0 0
AU001 - Brisbane
Recruitment hospital [3] 0 0
AU003 - Dandenc
Recruitment hospital [4] 0 0
AU004 - Epping
Recruitment hospital [5] 0 0
AU006 - Malvern
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment postcode(s) [2] 0 0
4053 - Brisbane
Recruitment postcode(s) [3] 0 0
3175 - Dandenc
Recruitment postcode(s) [4] 0 0
3076 - Epping
Recruitment postcode(s) [5] 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
Diest
Country [3] 0 0
Belgium
State/province [3] 0 0
Sint-Niklaas
Country [4] 0 0
Canada
State/province [4] 0 0
Mississauga
Country [5] 0 0
Canada
State/province [5] 0 0
Oakville
Country [6] 0 0
Canada
State/province [6] 0 0
Penticton
Country [7] 0 0
Canada
State/province [7] 0 0
Toronto
Country [8] 0 0
Canada
State/province [8] 0 0
Vancouver
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Brno
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha 2
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Praha 5
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Praha 6
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Sternberk
Country [14] 0 0
Finland
State/province [14] 0 0
Helsinki
Country [15] 0 0
Finland
State/province [15] 0 0
Järvenpää
Country [16] 0 0
Finland
State/province [16] 0 0
Seinäjoki
Country [17] 0 0
Finland
State/province [17] 0 0
Tampere
Country [18] 0 0
Finland
State/province [18] 0 0
Turku
Country [19] 0 0
France
State/province [19] 0 0
Angouleme
Country [20] 0 0
France
State/province [20] 0 0
Dole
Country [21] 0 0
France
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Montpellier
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France
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Orvault
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France
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Rouen
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France
State/province [24] 0 0
Savigny sur Orge
Country [25] 0 0
France
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Wattigny
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India
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Ahmedabab
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India
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Ahmedabad
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India
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Chennai
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India
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Hyderabaad
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India
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Mangalore
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India
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Pune
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
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Lithuania
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Kaunas
Country [35] 0 0
Lithuania
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Klaipeda
Country [36] 0 0
Lithuania
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Vilnius
Country [37] 0 0
Malaysia
State/province [37] 0 0
Kuala Lumpur
Country [38] 0 0
Norway
State/province [38] 0 0
Fredrikstad
Country [39] 0 0
Norway
State/province [39] 0 0
Hamar
Country [40] 0 0
Norway
State/province [40] 0 0
Skien
Country [41] 0 0
Philippines
State/province [41] 0 0
Las Pinas
Country [42] 0 0
Philippines
State/province [42] 0 0
Mandaluyong City
Country [43] 0 0
Philippines
State/province [43] 0 0
Mandaue City
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Arkhangelsk
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Nikolskoe
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Saratov
Country [47] 0 0
Russian Federation
State/province [47] 0 0
St-Petersburg
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Tomsk
Country [49] 0 0
Serbia
State/province [49] 0 0
Belgrade
Country [50] 0 0
Serbia
State/province [50] 0 0
Kragujevac
Country [51] 0 0
Sweden
State/province [51] 0 0
Halmstad
Country [52] 0 0
Sweden
State/province [52] 0 0
Linköping
Country [53] 0 0
Sweden
State/province [53] 0 0
Lund
Country [54] 0 0
Sweden
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Malmö
Country [55] 0 0
Sweden
State/province [55] 0 0
Stockholm
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Sweden
State/province [56] 0 0
Uppsala
Country [57] 0 0
Ukraine
State/province [57] 0 0
Dnepropetrovsk
Country [58] 0 0
Ukraine
State/province [58] 0 0
Kharkov
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Ukraine
State/province [59] 0 0
Kyiv
Country [60] 0 0
Ukraine
State/province [60] 0 0
Lviv
Country [61] 0 0
Ukraine
State/province [61] 0 0
Odessa

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
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

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/NCT00599911