- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488071
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication (REVIVE)
February 11, 2014 updated by: H. Lundbeck A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
495
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vortioxetine 10 mg or 20 mg
|
encapsulated tablets, daily, orally
Other Names:
|
Active Comparator: Agomelatine 25 mg or 50 mg
|
encapsulated tablets, daily, orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in MADRS Total Score at Week 8
Time Frame: Baseline and 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in MADRS Total Score at Week 12
Time Frame: Baseline and Week 12
|
Baseline and Week 12
|
|
Change From Baseline in HAM-A Total Score at Week 8
Time Frame: Baseline and 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
|
Change From Baseline in HAM-A Total Score at Week 12
Time Frame: Baseline and Week 12
|
Baseline and Week 12
|
|
Change From Baseline in CGI-S Score at Week 8
Time Frame: Baseline and 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
|
Change From Baseline in CGI-S Score at Week 12
Time Frame: Baseline and Week 12
|
Baseline and Week 12
|
|
Change in Clinical Status Using CGI-I Score at Week 8
Time Frame: 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
|
Change in Clinical Status Using CGI-I Score at Week 12
Time Frame: Week 12
|
Week 12
|
|
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
|
Baseline and Week 8
|
|
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
|
Baseline and Week 12
|
|
Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)
Time Frame: Week 8
|
Week 8
|
|
Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)
Time Frame: Week 12
|
Week 12
|
|
Change From Baseline in SDS Total Score at Week 8
Time Frame: Baseline and 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
|
Change From Baseline in SDS Total Score at Week 12
Time Frame: Baseline and Week 12
|
Baseline and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Papakostas GI, Nielsen RZ, Dragheim M, Tonnoir B. Efficacy and tolerability of vortioxetine versus agomelatine, categorized by previous treatment, in patients with major depressive disorder switched after an inadequate response. J Psychiatr Res. 2018 Jun;101:72-79. doi: 10.1016/j.jpsychires.2018.02.017. Epub 2018 Feb 22.
- Montgomery SA, Nielsen RZ, Poulsen LH, Haggstrom 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. doi: 10.1002/hup.2424.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion
December 6, 2022
Study Registration Dates
First Submitted
November 29, 2011
First Submitted That Met QC Criteria
December 6, 2011
First Posted (Estimate)
December 8, 2011
Study Record Updates
Last Update Posted (Estimate)
March 26, 2014
Last Update Submitted That Met QC Criteria
February 11, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin Antagonists
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- Serotonin 5-HT3 Receptor Antagonists
- Vortioxetine
- S 20098
Other Study ID Numbers
- 14178A
- 2011-002362-21 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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