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

This study has been terminated.
(Study was previously paused and is now terminated)
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00766870
First received: October 3, 2008
Last updated: September 28, 2010
Last verified: September 2010
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder Drug: Lu AA34893 Drug: Venlafaxine extended release Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Depressive symptoms as measured by the change from baseline in MADRS total score [ Time Frame: 8 weeks ]

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

Enrollment: 35
Study Start Date: September 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
4 Drug: Venlafaxine extended release
Per oral, once daily, 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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766870

Locations
Canada, Ontario
CA009
Mississauga, Ontario, Canada, ON L5M 4N4
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00766870     History of Changes
Other Study ID Numbers: 12279A
2007-007025-51 ( EudraCT Number )
Study First Received: October 3, 2008
Last Updated: September 28, 2010

Keywords provided by H. Lundbeck A/S:
Efficacy
Safety
Depression
Interventional
Placebo
Short-term
Major Depressive Disorder
Major Depressive Episode

Additional relevant MeSH terms:
Disease
Depressive Disorder, Major
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 22, 2017