Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)

• Status: Completed
• Trial end date: 2021-03-09
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

• The patient has a primary diagnosis of MDE, diagnosed according to DSM-5® confirmed using the Mini International Neuropsychiatric Interview (MINI).

• The patient has had the current MDE for <12 months

• The patient has current comorbid Generalized Anxiety Disorder (GAD) according to DSM-5®. The diagnosis was made prior to the current MDE

• The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥ 22 at the Baseline Visit

• The patient has a Hamilton Anxiety Rating Scale (HAM-A) score ≥ 20 at the Baseline Visit

Exclusion Criteria:

• The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.

• The patient has a history of previous major depressive episodes considered as treatment resistant, defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's opinion.

Other in- or exclusion criteria may apply