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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vortioxetine 10 mg or 20 mg

Group Type EXPERIMENTAL

Vortioxetine (Lu AA21004)

Intervention Type DRUG

encapsulated tablets, daily, orally

Agomelatine 25 mg or 50 mg

Group Type ACTIVE_COMPARATOR

Agomelatine

Intervention Type DRUG

encapsulated tablets, daily, orally

Interventions

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Vortioxetine (Lu AA21004)

encapsulated tablets, daily, orally

Intervention Type DRUG

Agomelatine

encapsulated tablets, daily, orally

Intervention Type DRUG

Other Intervention Names

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Brintellix® Valdoxan®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No