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

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Vortioxetine (Lu AA21004) Drug: Agomelatine	Phase 3


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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants

Drug Information available for: Vortioxetine Vortioxetine hydrobromide

U.S. FDA Resources

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:

Change From Baseline in MADRS Total Score at Week 8 [ Time Frame: Baseline and Week 8 ] [ 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, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.

Secondary Outcome Measures:

Change From Baseline in MADRS Total Score at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change From Baseline in HAM-A Total Score at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
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.
Change From Baseline in HAM-A Total Score at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change From Baseline in CGI-S Score at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
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.
Change From Baseline in CGI-S Score at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Clinical Status Using CGI-I Score at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
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.
Change in Clinical Status Using CGI-I Score at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Change From Baseline in SDS Total Score at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
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.
Change From Baseline in SDS Total Score at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]


Enrollment:	495
Study Start Date:	January 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vortioxetine 10 mg or 20 mg	Drug: Vortioxetine (Lu AA21004) encapsulated tablets, daily, orally Other Name: Brintellix®
Active Comparator: Agomelatine 25 mg or 50 mg	Drug: Agomelatine encapsulated tablets, daily, orally Other Name: Valdoxan®

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488071

Sponsors and Collaborators

H. Lundbeck A/S

Investigators


Study Director:	Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@lundbeck.com

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Montgomery SA, Nielsen RZ, Poulsen LH, Häggström L. A randomised, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor treatment switched to vortioxetine or agomelatine. Hum Psychopharmacol. 2014 Sep;29(5):470-82.


Responsible Party:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT01488071 History of Changes
Other Study ID Numbers:	14178A 2011-002362-21
Study First Received:	November 29, 2011
Results First Received:	December 19, 2013
Last Updated:	February 11, 2014
Health Authority:	Austria: Austrian Medicines and Medical Devices Agency Belgium: Federal Agency for Medicinal Products and Health Products Bulgaria: Bulgarian Drug Agency Czech Republic: State Institute for Drug Control Estonia: The State Agency of Medicine Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Lithuania: State Medicine Control Agency - Ministry of Health Poland: National Institute of Medicines Romania: National Agency for Medicines and Medical Devices Russia: FSI Scientific Center of Expertise of Medical Application Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by H. Lundbeck A/S:


Depression Multimodal antidepressant

Additional relevant MeSH terms:


Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Antidepressive Agents S 20098 Vortioxetine Psychotropic Drugs Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs	Anti-Anxiety Agents Tranquilizing Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin 5-HT1 Receptor Antagonists Serotonin Antagonists Serotonin 5-HT3 Receptor Antagonists

ClinicalTrials.gov processed this record on September 30, 2016

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