Dose-finding Study With Lu AA24530 in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599911
• Other study ID #: 11918A
• Secondary ID: 2007-001071-11
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2007
• Last updated: November 7, 2016
• Start date: October 2007
• Est. completion date: April 2009

Study information

• Verified date: November 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Ministry of HealthIndia: Ministry of HealthLithuania: State Medicine Control Agency - Ministry of HealthMalaysia: Ministry of HealthNorway: Norwegian Medicines AgencyPhilippines: Bureau of Food and DrugsRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSouth Korea: Korea Food and Drug Administration (KFDA)Sweden: Medical Products AgencyUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 652
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Lu AA24530
per oral, once daily for 6 weeks
• Duloxetine
per oral, once daily for 6 weeks
• Placebo
per oral, once daily for 6 weeks

Locations

Country	Name	City	State
Australia	AU001	Brisbane
Australia	AU002	Brisbane
Australia	AU003	Dandenc
Australia	AU004	Epping
Australia	AU006	Malvern
Austria	AT001	Vienna
Austria	AT002	Vienna
Austria	AT003	Vienna
Belgium	BE003	Diest
Belgium	BE002	Sint-Niklaas
Canada	CA006	Mississauga
Canada	CA004	Oakville
Canada	CA003	Penticton
Canada	CA005	Toronto
Canada	CA001	Vancouver
Czech Republic	CZ002	Brno
Czech Republic	CZ005	Praha 2
Czech Republic	CZ001	Praha 5
Czech Republic	CZ004	Praha 5
Czech Republic	CZ003	Praha 6
Czech Republic	CZ006	Sternberk
Finland	FI001	Helsinki
Finland	FI003	Helsinki
Finland	FI006	Järvenpää
Finland	FI004	Seinäjoki
Finland	FI005	Tampere
Finland	FI002	Turku
France	FR007	Angouleme
France	FR002	Dole
France	FR003	Montpellier
France	FR001	Orvault
France	FR008	Rouen
France	FR004	Savigny sur Orge
France	FR005	Wattigny
India	IN001	Ahmedabab
India	IN009	Ahmedabad
India	IN007	Chennai
India	IN006	Hyderabaad
India	IN003	Mangalore
India	IN002	Pune
Korea, Republic of	KR003	Gwangju
Korea, Republic of	KR001	Seoul
Korea, Republic of	KR002	Seoul
Lithuania	LT002	Kaunas
Lithuania	LT003	Klaipeda
Lithuania	LT001	Vilnius
Malaysia	MY002	Kuala Lumpur
Malaysia	MY003	Kuala Lumpur
Norway	NO004	Fredrikstad
Norway	NO001	Hamar
Norway	NO003	Skien
Philippines	PH002	Las Pinas
Philippines	PH003	Mandaluyong City
Philippines	PH001	Mandaue City
Russian Federation	RU005	Arkhangelsk
Russian Federation	RU002	Nikolskoe
Russian Federation	RU004	Saratov
Russian Federation	RU003	St-Petersburg
Russian Federation	RU001	Tomsk
Serbia	RS004	Belgrade
Serbia	RS002	Kragujevac
Sweden	SE006	Halmstad
Sweden	SE001	Linköping
Sweden	SE002	Lund
Sweden	SE003	Malmö
Sweden	SE005	Stockholm
Sweden	SE004	Uppsala
Ukraine	UA003	Dnepropetrovsk
Ukraine	UA005	Kharkov
Ukraine	UA002	Kyiv
Ukraine	UA004	Lviv
Ukraine	UA001	Odessa

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Canada,  Czech Republic,  Finland,  France,  India,  Korea, Republic of,  Lithuania,  Malaysia,  Norway,  Philippines,  Russian Federation,  Serbia,  Sweden,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score		6 weeks	No
Secondary	Response rate, remission rate, and safety		6 weeks	No