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Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries

Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Vortioxetine (Lu AA21004) (Drug); Venlafaxine extended release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

Summary

This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).

Clinical Details

Official title: Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in MADRS Total Score at Week 8

Secondary outcome:

Change in CGI-S Score From Baseline to Week 8

CGI-I Score at Week 8

Change in HAM-A Total Score From Baseline to Week 8

MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)

Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)

Number of Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The patient suffers from recurrent MDD as the primary diagnosis according to

DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)

- The patient has a MADRS total score ≥26

- The patient has a CGI-S score ≥4

- The reported duration of the current MDE is ≥3 months.

Other inclusion criteria may apply. Exclusion Criteria:

- The patient meets any of the exclusion criteria listed in the protocol or, in the

investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.

Locations and Contacts

Additional Information

Starting date: May 2012
Last updated: October 6, 2014

Page last updated: August 23, 2015

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