A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication

Major Depressive Disorder Clinical Trial

— REVIVE  

Official title:

A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of [Vortioxetine] Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488071
• Other study ID #: 14178A
• Secondary ID: 2011-002362-21
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2011
• Last updated: February 11, 2014
• Start date: January 2012

Study information

• Verified date: February 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyLithuania: State Medicine Control Agency - Ministry of HealthPoland: National Institute of MedicinesRomania: National Agency for Medicines and Medical DevicesRussia: FSI Scientific Center of Expertise of Medical ApplicationSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The patient is being treated with a serotonin reuptake inhibitor (SRI) antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)

• The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline

• Montgomery Åsberg Depression Rating Scale (MADRS) total score =22 at the Screening Visit and Baseline

• The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception

Exclusion Criteria:

• The patient has any current Axis I disorders (DSM-IV criteria) other than Major Depressive Disorder (MDD), General Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD)

• The patient is at significant risk of suicide

• The patient is currently receiving formal psychotherapy or other psychoactive medications

Other protocol-defined inclusion and exclusion criteria may apply.

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)
encapsulated tablets, daily, orally
• Agomelatine
encapsulated tablets, daily, orally

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	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, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.	Baseline and Week 8	No
Secondary	Change From Baseline in MADRS Total Score at Week 12		Baseline and Week 12	No
Secondary	Change From Baseline in HAM-A Total Score at Week 8	The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score 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	Change From Baseline in HAM-A Total Score at Week 12		Baseline and Week 12	No
Secondary	Change From Baseline in CGI-S Score at Week 8	The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. 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	Change From Baseline in CGI-S Score at Week 12		Baseline and Week 12	No
Secondary	Change in Clinical Status Using CGI-I Score at Week 8	The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. Higher score = more affected.	Week 8	No
Secondary	Change in Clinical Status Using CGI-I Score at Week 12		Week 12	No
Secondary	Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)		Baseline and Week 8	No
Secondary	Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)		Baseline and Week 12	No
Secondary	Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)		Week 8	No
Secondary	Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)		Week 12	No
Secondary	Change From Baseline in SDS Total Score at Week 8	The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). 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 From Baseline in SDS Total Score at Week 12		Baseline and Week 12	No