Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder

September 28, 2010 updated by: H. Lundbeck A/S

A Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active-referenced Study Evaluating the Efficacy and Safety of Three Fixed Dose Regimens of Lu AA34893 in the Treatment of Major Depressive Disorder

The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.

Study Type

Interventional

Enrollment (Actual)

35

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

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, ON L5M 4N4
        • CA009

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

In- and out-patients with moderate to severe Major Depressive Disorder

Inclusion Criteria:

  • Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (classification code 296.xx)
  • Moderate to severe depression
  • Current MDE duration of at least 3 months

Exclusion Criteria:

  • Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
  • Any substance disorder within the previous 6 months
  • Females of childbearing potential and not using adequate contraception
  • Use of any psychoactive medication within 2 weeks before randomisation and during the study

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: Lu AA34893
Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
EXPERIMENTAL: 2
Drug: Lu AA34893
Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
EXPERIMENTAL: 3
Drug: Lu AA34893
Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
PLACEBO_COMPARATOR: 5
Drug: Placebo
Per oral doses, twice daily as capsules during 10 weeks
OTHER: 4
Drug: Venlafaxine extended release
Per oral, once daily, during 8 weeks, followed by a two-week tapering period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depressive symptoms as measured by the change from baseline in MADRS total score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

H. Lundbeck A/S

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

September 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (ESTIMATE)

October 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2010

Last Update Submitted That Met QC Criteria

September 28, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12279A
  • 2007-007025-51 (EUDRACT_NUMBER)

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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