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Long-term Study of Lu AA21004 in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00761306
First received: September 26, 2008
Last updated: June 18, 2012
Last verified: June 2012
History of Changes

September 26, 2008
June 18, 2012
June 2007
September 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00761306 on ClinicalTrials.gov Archive Site
  • Maintenance of therapeutic effect [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-term Study of Lu AA21004 in Patients With Major Depressive Disorder
A Long-term, Open-label Study Evaluating the Safety and Tolerability of Lu AA21004 in Patients With Major Depressive Disorder

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 having completed 6-week acute treatment.

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 of at least 6 months. The adverse event profile plays a large role in the choice of antidepressant therapy and the compliance during long-term treatment.
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Lu AA21004
5-10 mg/day
Other Name: Vortioxetine
Experimental: Lu AA21004
Intervention: Drug: Lu AA21004
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
October 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who completed 6-week short-term treatment study for Major Depressive Episode followed by a 2-week taper period

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00761306
11492C, 2007-000905-31
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP