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Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761306
First Posted: September 29, 2008
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lundbeck A/S
September 26, 2008
September 29, 2008
October 28, 2013
December 17, 2013
January 29, 2014
June 2007
September 2008   (Final data collection date for primary outcome measure)
  • Number of Patients With Adverse Events (AEs) [ Time Frame: Up to 52 weeks and a 4-week safety follow-up period ]
  • Percentage of Patients Who Withdrew Due to Intolerance to Treatment [ Time Frame: Baseline to Week 52 ]
Safety and tolerability assessed by adverse events, clinical safety laboratory tests, vital signs, weight, ECG and physical examination [ Time Frame: 52 weeks ]
Complete list of historical versions of study NCT00761306 on ClinicalTrials.gov Archive Site
  • Change From Baseline in MADRS Total Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ]
    The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.
  • Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ]
    The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
  • Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) [ Time Frame: Week 52 ]
  • Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 52 ]
  • Maintenance of therapeutic effect [ Time Frame: 52 weeks ]
  • Health related quality of life [ Time Frame: 52 weeks ]
  • Pharmacokinetics [ Time Frame: 52 weeks ]
Not Provided
Not Provided
 
Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
A Long-term, Open-label Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 6-week acute treatment in study NCT00839423 / 11492A.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Vortioxetine (Lu AA21004)
5 or 10 mg/day; tablets; orally
Other Name: Brintellix
Experimental: Vortioxetine
Intervention: Drug: Vortioxetine (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 (MDE), NCT00839423 / 11492A, followed by a 2-week taper period

Exclusion Criteria:

  • Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00761306
11492C
2007-000905-31 ( EudraCT Number )
No
Not Provided
Not Provided
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
December 2013

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