Long-term Safety Study of Lu AA21004 in Patients With Major Depressive Disorder - Full Text View

Sponsor:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00694304

Purpose

The purpose of the study is to evaluate long-term safety and tolerability of Lu AA21004 over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Lu AA21004	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability 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:

Safety and tolerability assessed by adverse events, clinical safety laboratory tests, vital signs, weight, ECG and physical examination [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the maintenance of therapeutic effect of Lu AA21004 over long-term treatment period [ Time Frame: 52 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: 52 weeks ] [ Designated as safety issue: No ]
To evaluate the effect of Lu AA21004 on Health Related Quality of Life (HRQL), on disability and on health care resource utilisation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	536
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lu AA21004: Experimental	Drug: Lu AA21004 Flexible dose 2.5 - 10 mg/day

Detailed Description:

Depression is a common mental disorder 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. Depression may become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. The need for the treatment of the depressive episode beyond the acute period of treatment has been well documented and the duration of treatment is usually set at about 6 months. The adverse event profile plays a large role in the choice of antidepressant therapy and safety aspects of a drug in relation to the duration of treatment have to be addressed.

Eligibility

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

Criteria

Inclusion Criteria:

Patients who completed 8-week short-term treatment study for Major Depressive Episode

Exclusion Criteria:

Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
Female patients of childbearing potential who are not using effective contraception
Use of any psychoactive medication

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694304

Show 87 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:	11984B, EudraCT 2007-004992-21
Study First Received:	June 6, 2008
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00694304 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; France: Afssaps - French Health Products Safety Agency; Philippines: Bureau of Food and Drugs; South Korea: Korea Food and Drug Administration (KFDA); Spain: Spanish Agency of Medicines; Taiwan: National Bureau of Controlled Drugs; Ukraine: Ministry of Health

Keywords provided by H. Lundbeck A/S:

Major Depressive Disorder
Long-term
Safety
Open-label

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 February 08, 2010