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:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00761306
First received: September 26, 2008
Last updated: December 23, 2013
Last verified: December 2013

September 26, 2008
December 23, 2013
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 ] [ Designated as safety issue: Yes ]
  • Percentage of Patients Who Withdrew Due to Intolerance to Treatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
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 ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • 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 ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

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
December 2013

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