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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571453
• Other study ID #: 13926A
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2012
• Last updated: October 6, 2014
• Start date: May 2012

Study information

• Verified date: October 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationTaiwan : Food and Drug AdministrationChina: Food and Drug AdministrationThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine (Lu AA21004)
10 mg/day
• Venlafaxine extended release
150 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in MADRS Total Score at Week 8	Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.	Baseline and Week 8	No
Secondary	Change in CGI-S Score From Baseline to Week 8	Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.	Baseline and Week 8	No
Secondary	CGI-I Score at Week 8	The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.	Week 8	No
Secondary	Change in HAM-A Total Score From Baseline to Week 8	Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.	Baseline and Week 8	No
Secondary	MADRS Response at Week 8 (Response Defined as a =50% Decrease in the MADRS Total Score From Baseline)		Week 8	No
Secondary	Remission at Week 8 (Remission Defined as a MADRS Total Score =10)		Week 8	No
Secondary	Number of Adverse Events		Baseline to Week 12	Yes