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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00766870     History of Changes
Other Study ID Numbers: 12279A, 2007-007025-51
Study First Received: October 3, 2008
Last Updated: September 28, 2010
Health Authority: Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014