Clinical trial NCT00599911: Dose-finding Study With Lu AA24530 in Major Depressive Disorder
Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Drug therapy
Depressive disorder
Antidepressive agents
Depressive symptoms
Affective disorders
Randomized controlled trial
Placebo-controlled
Double-blind
Active reference
Multicenter study
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-01-24
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: According to the World Health Organisation, Major Depressive Disorder is the leading cause of disability and the 4th leading contributor to the global burden of disease. There are unmet medical needs in the treatment of depressive disorders in terms of insufficient effectiveness and unpleasant side-effects of current therapies. The overall prognosis of the disorder is positive for the majority of patients, but as many as 30% of patients will develop a chronic and treatment-resistant depression. In the study, patients with depression are treated for 6 weeks. Assessments of efficacy and safety are taking place every week for the first 4 weeks and again after 6 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* Major Depressive Episode that has lasted at least 3 months
* Moderate to severe depression

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

Primary outcomes:
measure: The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score
timeFrame: 6 weeks
Secondary outcomes:
measure: Response rate, remission rate, and safety
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: AU002
city: Brisbane
country: Australia
facility: AU001
city: Dandenc
country: Australia
facility: AU003
city: Epping
country: Australia
facility: AU004
city: Malvern
country: Australia
facility: AU006
city: Vienna
country: Austria
facility: AT001
city: Vienna
country: Austria
facility: AT002
city: Vienna
country: Austria
facility: AT003
city: Diest
country: Belgium
facility: BE003
city: Sint-Niklaas
country: Belgium
facility: BE002
city: Mississauga
country: Canada
facility: CA006
city: Oakville
country: Canada
facility: CA004
city: Penticton
country: Canada
facility: CA003
city: Toronto
country: Canada
facility: CA005
city: Vancouver
country: Canada
facility: CA001
city: Brno
country: Czech Republic
facility: CZ002
city: Praha 2
country: Czech Republic
facility: CZ005
city: Praha 5
country: Czech Republic
facility: CZ001
city: Praha 5
country: Czech Republic
facility: CZ004
city: Praha 6
country: Czech Republic
facility: CZ003
city: Sternberk
country: Czech Republic
facility: CZ006
city: Helsinki
country: Finland
facility: FI001
city: Helsinki
country: Finland
facility: FI003
city: Järvenpää
country: Finland
facility: FI006
city: Seinäjoki
country: Finland
facility: FI004
city: Tampere
country: Finland
facility: FI005
city: Turku
country: Finland
facility: FI002
city: Angouleme
country: France
facility: FR007
city: Dole
country: France
facility: FR002
city: Montpellier
country: France
facility: FR003
city: Orvault
country: France
facility: FR001
city: Rouen
country: France
facility: FR008
city: Savigny sur Orge
country: France
facility: FR004
city: Wattigny
country: France
facility: FR005
city: Ahmedabab
country: India
facility: IN001
city: Ahmedabad
country: India
facility: IN009
city: Chennai
country: India
facility: IN007
city: Hyderabaad
country: India
facility: IN006
city: Mangalore
country: India
facility: IN003
city: Pune
country: India
facility: IN002
city: Gwangju
country: Korea, Republic of
facility: KR003
city: Seoul
country: Korea, Republic of
facility: KR002
city: Seoul
country: Korea, Republic of
facility: KR001
city: Kaunas
country: Lithuania
facility: LT002
city: Klaipeda
country: Lithuania
facility: LT003
city: Vilnius
country: Lithuania
facility: LT001
city: Kuala Lumpur
country: Malaysia
facility: MY002
city: Kuala Lumpur
country: Malaysia
facility: MY003
city: Fredrikstad
country: Norway
facility: NO004
city: Hamar
country: Norway
facility: NO001
city: Skien
country: Norway
facility: NO003
city: Las Pinas
country: Philippines
facility: PH002
city: Mandaluyong City
country: Philippines
facility: PH003
city: Mandaue City
country: Philippines
facility: PH001
city: Arkhangelsk
country: Russian Federation
facility: RU005
city: Nikolskoe
country: Russian Federation
facility: RU002
city: Saratov
country: Russian Federation
facility: RU004
city: St-Petersburg
country: Russian Federation
facility: RU003
city: Tomsk
country: Russian Federation
facility: RU001
city: Belgrade
country: Serbia
facility: RS004
city: Kragujevac
country: Serbia
facility: RS002
city: Halmstad
country: Sweden
facility: SE006
city: Linköping
country: Sweden
facility: SE001
city: Lund
country: Sweden
facility: SE002
city: Malmö
country: Sweden
facility: SE003
city: Stockholm
country: Sweden
facility: SE005
city: Uppsala
country: Sweden
facility: SE004
city: Dnepropetrovsk
country: Ukraine
facility: UA003
city: Kharkov
country: Ukraine
facility: UA005
city: Kyiv
country: Ukraine
facility: UA002
city: Lviv
country: Ukraine
facility: UA004
city: Odessa
country: Ukraine
facility: UA001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.