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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Antidepressive Agents; S 20098; Vortioxetine

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.