Dose-finding Study With Lu AA24530 in Major Depressive Disorder

November 7, 2016 updated by: H. Lundbeck A/S

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

652

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia, 4000
        • AU002
      • Brisbane, Australia, 4053
        • AU001
      • Dandenc, Australia, 3175
        • AU003
      • Epping, Australia, 3076
        • AU004
      • Malvern, Australia, 3144
        • AU006
  • Austria
      • Vienna, Austria, 1090
        • AT001
      • Vienna, Austria
        • AT002
      • Vienna, Austria
        • AT003
  • Belgium
      • Diest, Belgium, 2930
        • BE003
      • Sint-Niklaas, Belgium, 9100
        • BE002
  • Canada
      • Mississauga, Canada, L5M 4N4
        • CA006
      • Oakville, Canada, L6J 7W5
        • CA004
      • Penticton, Canada, V2A 4M4
        • CA003
      • Toronto, Canada, M4S 1Y2
        • CA005
      • Vancouver, Canada, V6Z 2L4
        • CA001
  • Czech Republic
      • Brno, Czech Republic, 60200
        • CZ002
      • Praha 2, Czech Republic, 12000
        • CZ005
      • Praha 5, Czech Republic, 15030
        • CZ001
      • Praha 5, Czech Republic, 158 00
        • CZ004
      • Praha 6, Czech Republic, 16000
        • CZ003
      • Sternberk, Czech Republic, 78517
        • CZ006
  • Finland
      • Helsinki, Finland, 00260
        • FI001
      • Helsinki, Finland, 00530
        • FI003
      • Järvenpää, Finland
        • FI006
      • Seinäjoki, Finland
        • FI004
      • Tampere, Finland
        • FI005
      • Turku, Finland, 20100
        • FI002
  • France
      • Angouleme, France, 16000
        • FR007
      • Dole, France, 39100
        • FR002
      • Montpellier, France, 34000
        • FR003
      • Orvault, France, 44700
        • FR001
      • Rouen, France, 76000
        • FR008
      • Savigny sur Orge, France, 91600
        • FR004
      • Wattigny, France, 59139
        • FR005
  • India
      • Ahmedabab, India
        • IN001
      • Ahmedabad, India
        • IN009
      • Chennai, India, 3
        • IN007
      • Hyderabaad, India, 500 034
        • IN006
      • Mangalore, India, 574160
        • IN003
      • Pune, India, 411004
        • IN002
  • Korea, Republic of
      • Gwangju, Korea, Republic of, 501-757
        • KR003
      • Seoul, Korea, Republic of, 120-752
        • KR002
      • Seoul, Korea, Republic of, 138-746
        • KR001
  • Lithuania
      • Kaunas, Lithuania, 50185
        • LT002
      • Klaipeda, Lithuania, 91251
        • LT003
      • Vilnius, Lithuania
        • LT001
  • Malaysia
      • Kuala Lumpur, Malaysia, 55100
        • MY002
      • Kuala Lumpur, Malaysia, 59100
        • MY003
  • Norway
      • Fredrikstad, Norway, 1606
        • NO004
      • Hamar, Norway, 2315
        • NO001
      • Skien, Norway, 3725
        • NO003
  • Philippines
      • Las Pinas, Philippines, 1701
        • PH002
      • Mandaluyong City, Philippines
        • PH003
      • Mandaue City, Philippines, 6014
        • PH001
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163061
        • RU005
      • Nikolskoe, Russian Federation, 188357
        • RU002
      • Saratov, Russian Federation, 410028
        • RU004
      • St-Petersburg, Russian Federation, 190005
        • RU003
      • Tomsk, Russian Federation, 634014
        • RU001
  • Serbia
      • Belgrade, Serbia, 11000
        • RS004
      • Kragujevac, Serbia, 34000
        • RS002
  • Sweden
      • Halmstad, Sweden, 301 85
        • SE006
      • Linköping, Sweden, 581 85
        • SE001
      • Lund, Sweden, 223 61
        • SE002
      • Malmö, Sweden, 21237
        • SE003
      • Stockholm, Sweden, 112 34
        • SE005
      • Uppsala, Sweden, 753 19
        • SE004
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49005
        • UA003
      • Kharkov, Ukraine, 61068
        • UA005
      • Kyiv, Ukraine, 4080
        • UA002
      • Lviv, Ukraine, 79021
        • UA004
      • Odessa, Ukraine, 65006
        • UA001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
per oral, once daily for 6 weeks
Experimental: Lu AA24530: 5 mg
Drug: Lu AA24530
per oral, once daily for 6 weeks
Experimental: Lu AA24530: 10 mg
Drug: Lu AA24530
per oral, once daily for 6 weeks
Experimental: Lu AA24530: 20 mg
Drug: Lu AA24530
per oral, once daily for 6 weeks
Active Comparator: Duloxetine: 60 mg
Drug: Duloxetine
per oral, once daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate, remission rate, and safety
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11918A
  • 2007-001071-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. EMA EudraCT Results
    Information identifier: 2007-001071-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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