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
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
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, India, Korea, Republic of, Lithuania, Malaysia, Norway, Philippines, Russian Federation, Serbia, Sweden, Ukraine,
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 |
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