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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00766870
• Other study ID #: 12279A
• Secondary ID: 2007-007025-51
• Status: Terminated
• Phase: Phase 2
• First received: October 3, 2008
• Last updated: September 28, 2010
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: September 2010
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Lu AA34893
Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
• Venlafaxine extended release
Per oral, once daily, during 8 weeks, followed by a two-week tapering period
• Placebo
Per oral doses, twice daily as capsules during 10 weeks

Locations

Country	Name	City	State
Canada	CA009	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms as measured by the change from baseline in MADRS total score		8 weeks	No
Secondary	HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination		8 weeks	Yes