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

Last updated: September 28, 2010
Sponsor: H. Lundbeck A/S
Overall Status: Terminated

Phase

2

Condition

Depression (Major/severe)

Depression

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00766870
12279A
2007-007025-51
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 thestudy

Study Design

Total Participants: 35
Study Start date:
September 01, 2008
Estimated Completion Date:
February 28, 2009

Study 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.

Connect with a study center

  • CA009

    Mississauga, Ontario ON L5M 4N4
    Canada

    Site Not Available

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