Efficacy of Lu AA21004 in the Prevention of Relapse of Major Depressive Episodes - Full Text View

Purpose

This study will evaluate the efficacy of Lu AA21004 in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Lu AA21004.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Lu AA21004 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of Lu AA21004 in Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

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

Primary Outcome Measures:

Time to relapse [ Time Frame: 24 weeks of the double-blind period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate efficacy of Lu AA21004 during continuation treatment of patients with MDD [ Time Frame: 24 weeks up to 64 weeks of the double-blind period ] [ Designated as safety issue: No ]
To evaluate long-term safety and tolerability of Lu AA21004 in patients with MDD [ Time Frame: Up to 76 weeks ] [ Designated as safety issue: Yes ]
To evaluate potential discontinuation symptoms after abrupt discontinuation of treatment with Lu AA21004 [ Time Frame: Not specified in the protocol ] [ Designated as safety issue: Yes ]
To evaluate the effect of Lu AA21004 on Health Related Quality of Life, disability and health care resource utilization [ Time Frame: Up to 76 weeks ] [ Designated as safety issue: No ]
To evaluate the effect of the Lu AA21004 on fatigue as assessed by the Fatigue Severity Scale (FSS) [ Time Frame: Up to 76 weeks ] [ Designated as safety issue: No ]
To evaluate the population pharmacokinetics and pharmacodynamics of Lu AA21004 and its metabolites Lu AA34443 and Lu AA39835 [ Time Frame: 12 weeks of the open-label period ] [ Designated as safety issue: No ]

Enrollment:	404
Study Start Date:	December 2007
Study Completion Date:	October 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1: 5 or 10 mg	Drug: Lu AA21004 per oral, 5 or 10 mg/day Other Name: Vortioxetine
Placebo Comparator: 2: Placebo	Drug: Placebo per oral

Detailed Description:

Depression is increasingly recognized as a highly recurrent and potentially chronic illness that imposes a substantial burden on individuals, families, and society. Major depressive disorder (MDD) is among the most important causes of disability worldwide, in both developing and developed countries. The risk of relapse or recurrence, chronicity (as measured by the duration of episodes) and treatment resistance increases with each new episode. Thus, treatment to full remission and continued treatment to prevent relapse and recurrence are both major priorities for management of recurrent MDD.

Due to the character of the disorder, long-term studies are necessary to demonstrate that the short-term effect is maintained during an episode. As recommended by the CPMP guideline for investigation in MDD, a randomised withdrawal study (relapse prevention study) is the most appropriate design.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
At least one other MDE before the current one
Moderate to severe depression

Exclusion Criteria:

Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
Any substance disorder within the previous 6 months
Female patients of childbearing potential who are not using effective contraception
Use of any psychoactive medication 2 weeks prior to screening and during the study

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596817

Show 68 Study Locations

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:	NCT00596817 History of Changes
Other Study ID Numbers:	11985A, 2007-001871-13
Study First Received:	January 8, 2008
Last Updated:	December 7, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Canada: Health Canada 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 India: Ministry of Health Norway: Norwegian Medicines Agency Poland: The Central Register of Clinical Trials South Korea: Korea Food and Drug Administration (KFDA) Sweden: Medical Products Agency Taiwan: National Bureau of Controlled Drugs Thailand: Food and Drug Administration Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency South Africa: Medicines Control Council

Keywords provided by H. Lundbeck A/S:

Relapse prevention
Antidepressants
Placebo-controlled
Double-blind
Multicentre study

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013