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

Sponsored by:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00596817

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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: Not specified in the protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relapse rates; Efficacy and safety and tolerability of Lu AA21004 during continuation treatment of patients with MDD; Evaluate potential discontinuation symptoms; Effect of Lu AA21004 on Health Related Quality of Life and disability [ Time Frame: Not specified in the protocol ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
1: 5 or 10 mg: Experimental	Drug: Lu AA21004 per oral, 5 or 10 mg/day
2: Placebo: Placebo Comparator	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 ( H. Lundbeck A/S )
Study ID Numbers:	11985A, EudraCT 2007-001871-13
Study First Received:	January 8, 2008
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00596817 History of Changes
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: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; India: Ministry of Health; Norway: Norwegian Medicines Agency; 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

Keywords provided by H. Lundbeck A/S:

Relapse prevention
Antidepressants
Placebo-controlled
Double-blind
Multicentre study

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease
Depression
Mental Disorders

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 11, 2009