Status:
COMPLETED
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 inad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT01488071
Start Date
January 1 2012
Last Update
March 26 2014
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