Interventional, open-label effectiveness study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder comorbid with generalized anxiety disorder - Reconnect

H. LUNDBECK A/S0 sites100 target enrollmentStarted: October 7, 2020Last updated: December 7, 2020

Conditions

Drugs

Trial Snapshot

No summary available.

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.

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