A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication (REVIVE)
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| ClinicalTrials.gov Identifier: NCT01488071 |
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Recruitment Status :
Completed
First Posted : December 8, 2011
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
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Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Major Depressive Disorder |
| Interventions |
Drug: Vortioxetine (Lu AA21004) Drug: Agomelatine |
| Enrollment | 495 |
Participant Flow
| Recruitment Details | In- or outpatients who had been treated with antidepressant selective serotonin reuptake inhibitor (SSRI) or selective noradrenaline reuptake inhibitor (SNRI) monotherapy that was prescribed to treat a single episode of Major Depressive Disorder (MDD) or recurrent MDD. |
| Pre-assignment Details | The study will consist of a screening period of 4 to 10 days before the Baseline Visit, followed by a 12-week treatment period with vortioxetine or agomelatine. A safety follow-up will be done approximately 4 weeks after the Completion/Withdrawal Visit. |
| Arm/Group Title | Vortioxetine 10 mg or 20 mg | Agomelatine 25 mg or 50 mg |
|---|---|---|
 Arm/Group Description |
encapsulated tablets, daily, orally | encapsulated tablets, daily, orally |
| Period Title: Overall Study | ||
| Started | 253 [1] | 242 [2] |
| Completed | 200 | 179 |
| Not Completed | 53 | 63 |
| Reason Not Completed | ||
| Adverse Event | 15 | 23 |
| Lack of Efficacy | 11 | 17 |
| Non-compliance with study drug | 2 | 0 |
| Protocol Violation | 5 | 7 |
| Withdrawal of Consent | 14 | 12 |
| Lost to Follow-up | 1 | 0 |
| Administrative or Other Reason(s) | 5 | 4 |
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[1]
all-patients-treated set (APTS)
[2]
APTS
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Baseline Characteristics
| Arm/Group Title | Vortioxetine 10 mg or 20 mg | Agomelatine 25 mg or 50 mg | Total | |
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Arm/Group Description |
encapsulated tablets, daily, orally | encapsulated tablets, daily, orally | Total of all reporting groups | |
| Overall Number of Baseline Participants | 253 | 242 | 495 | |
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Baseline Analysis Population Description |
Age and Gender: All-patients-treated set (APTS) - all patients in the APRS who took at least one dose of investigational medicinal product (IMP).
Study Specific Characteristics: Full-analysis set (FAS) - all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 253 participants | 242 participants | 495 participants | |
| 47.0 (12.4) | 45.6 (12.4) | 46.3 (12.4) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 253 participants | 242 participants | 495 participants | |
| Female |
195 77.1%
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175 72.3%
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370 74.7%
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| Male |
58 22.9%
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67 27.7%
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125 25.3%
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MADRS: Baseline Total Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 253 participants | 242 participants | 495 participants | |
| 29.1 (4.4) | 28.7 (4.0) | 28.9 (4.2) | ||
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[1]
Measure Description: 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 - 60. The higher the score, the more severe.
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HAM-A: Baseline Total Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 253 participants | 242 participants | 495 participants | |
| 21.6 (6.3) | 21.4 (6.2) | 21.5 (6.2) | ||
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[1]
Measure Description: 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.
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CGI-S Baseline Severity Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 253 participants | 242 participants | 495 participants | |
| 4.4 (0.6) | 4.4 (0.6) | 4.4 (0.6) | ||
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[1]
Measure Description: 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 patient is more ill.
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SDS Total Baseline Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 253 participants | 242 participants | 495 participants | |
| 19.2 (5.3) | 19.3 (5.2) | 19.3 (5.3) | ||
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[1]
Measure Description: 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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The results of this study will be published. Authors of the primary publication based on this study must fulfil the criteria defined by the International Committee of Medical Journal Editors (ICMJE). The primary publication must be published before any secondary publications are submitted for publication.
Results Point of Contact
| Name/Title: | H. Lundbeck A/S |
| Organization: | H. Lundbeck A/S |
| Phone: | +45 36301311 |
| EMail: | LundbeckClinicalTrials@lundbeck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT01488071 |
| Other Study ID Numbers: |
14178A 2011-002362-21 ( EudraCT Number ) |
| First Submitted: | November 29, 2011 |
| First Posted: | December 8, 2011 |
| Results First Submitted: | December 19, 2013 |
| Results First Posted: | March 26, 2014 |
| Last Update Posted: | March 26, 2014 |