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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
State/province [21] 0 0
Montpellier
Country [22] 0 0
France
State/province [22] 0 0
Orvault
Country [23] 0 0
France
State/province [23] 0 0
Rouen
Country [24] 0 0
France
State/province [24] 0 0
Savigny sur Orge
Country [25] 0 0
France
State/province [25] 0 0
Wattigny
Country [26] 0 0
India
State/province [26] 0 0
Ahmedabab
Country [27] 0 0
India
State/province [27] 0 0
Ahmedabad
Country [28] 0 0
India
State/province [28] 0 0
Chennai
Country [29] 0 0
India
State/province [29] 0 0
Hyderabaad
Country [30] 0 0
India
State/province [30] 0 0
Mangalore
Country [31] 0 0
India
State/province [31] 0 0
Pune
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Gwangju
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Lithuania
State/province [34] 0 0
Kaunas
Country [35] 0 0
Lithuania
State/province [35] 0 0
Klaipeda
Country [36] 0 0
Lithuania
State/province [36] 0 0
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
State/province [54] 0 0
Malmö
Country [55] 0 0
Sweden
State/province [55] 0 0
Stockholm
Country [56] 0 0
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
Country [59] 0 0
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
The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo
Trial website
https://clinicaltrials.gov/study/NCT00599911
Trial related presentations / publications
Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.
Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Muller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3):18m12556. doi: 10.4088/JCP.18m12556.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00599911