Dose-finding Study With Lu AA24530 in Major Depressive Disorder

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Lu AA24530; Drug: Duloxetine

• Registration Number: NCT00599911
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-24
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 652

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Lu AA24530: 5 mg	Lu AA24530	-
Lu AA24530: 10 mg	Lu AA24530	-
Lu AA24530: 20 mg	Lu AA24530	-
Duloxetine: 60 mg	Duloxetine	-

Primary Outcome Measures

Name	Time	Method
The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score	6 weeks

Secondary Outcome Measures

Name	Time	Method
Response rate, remission rate, and safety	6 weeks

Trial Locations

Locations (72)

UA001; 🇺🇦 Odessa, Ukraine

UA005; 🇺🇦 Kharkov, Ukraine

BE003; 🇧🇪 Diest, Belgium

CZ001; 🇨🇿 Praha 5, Czech Republic

FR005; 🇫🇷 Wattigny, France

AT002; 🇦🇹 Vienna, Austria

CA005; 🇨🇦 Toronto, Canada

RU003; 🇷🇺 St-Petersburg, Russian Federation

CA003; 🇨🇦 Penticton, Canada

AT003; 🇦🇹 Vienna, Austria

CZ005; 🇨🇿 Praha 2, Czech Republic

AU004; 🇦🇺 Epping, Australia

AU003; 🇦🇺 Dandenc, Australia

AU006; 🇦🇺 Malvern, Australia

RU002; 🇷🇺 Nikolskoe, Russian Federation

FI001; 🇫🇮 Helsinki, Finland

UA003; 🇺🇦 Dnepropetrovsk, Ukraine

UA002; 🇺🇦 Kyiv, Ukraine

SE006; 🇸🇪 Halmstad, Sweden

KR003; 🇰🇷 Gwangju, Korea, Republic of

RU005; 🇷🇺 Arkhangelsk, Russian Federation

FR002; 🇫🇷 Dole, France

KR002; 🇰🇷 Seoul, Korea, Republic of

FR003; 🇫🇷 Montpellier, France

UA004; 🇺🇦 Lviv, Ukraine

FI004; 🇫🇮 Seinäjoki, Finland

IN001; 🇮🇳 Ahmedabab, India

LT001; 🇱🇹 Vilnius, Lithuania

PH001; 🇵🇭 Mandaue City, Philippines

SE001; 🇸🇪 Linköping, Sweden

SE002; 🇸🇪 Lund, Sweden

SE003; 🇸🇪 Malmö, Sweden

SE005; 🇸🇪 Stockholm, Sweden

SE004; 🇸🇪 Uppsala, Sweden

CA004; 🇨🇦 Oakville, Canada

CA001; 🇨🇦 Vancouver, Canada

RU004; 🇷🇺 Saratov, Russian Federation

RU001; 🇷🇺 Tomsk, Russian Federation

AU002; 🇦🇺 Brisbane, Australia

AU001; 🇦🇺 Brisbane, Australia

CA006; 🇨🇦 Mississauga, Canada

BE002; 🇧🇪 Sint-Niklaas, Belgium

FR004; 🇫🇷 Savigny sur Orge, France

CZ006; 🇨🇿 Sternberk, Czech Republic

CZ003; 🇨🇿 Praha 6, Czech Republic

FI003; 🇫🇮 Helsinki, Finland

FI002; 🇫🇮 Turku, Finland

FR001; 🇫🇷 Orvault, France

FI005; 🇫🇮 Tampere, Finland

FR008; 🇫🇷 Rouen, France

FR007; 🇫🇷 Angouleme, France

NO001; 🇳🇴 Hamar, Norway

IN002; 🇮🇳 Pune, India

MY002; 🇲🇾 Kuala Lumpur, Malaysia

IN006; 🇮🇳 Hyderabaad, India

IN003; 🇮🇳 Mangalore, India

KR001; 🇰🇷 Seoul, Korea, Republic of

LT003; 🇱🇹 Klaipeda, Lithuania

AT001; 🇦🇹 Vienna, Austria

LT002; 🇱🇹 Kaunas, Lithuania

MY003; 🇲🇾 Kuala Lumpur, Malaysia

CZ004; 🇨🇿 Praha 5, Czech Republic

CZ002; 🇨🇿 Brno, Czech Republic

IN007; 🇮🇳 Chennai, India

NO003; 🇳🇴 Skien, Norway

PH002; 🇵🇭 Las Pinas, Philippines

NO004; 🇳🇴 Fredrikstad, Norway

FI006; 🇫🇮 Järvenpää, Finland

IN009; 🇮🇳 Ahmedabad, India

PH003; 🇵🇭 Mandaluyong City, Philippines

RS004; 🇷🇸 Belgrade, Serbia

RS002; 🇷🇸 Kragujevac, Serbia