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

Lundbeck

Status and phase: Completed; Phase 4

Conditions: Anxiety Disorders; MDD

Treatments: Drug: Vortioxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04220996

18314A

Details and patient eligibility

About

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

Full description

100 patients, recruited from psychiatrist outpatient clinics are planned for enrolment. Approximately 50 of these patients will receive vortioxetine as a first treatment for the current Major Depressive Episode (MDE) (first treatment patients) and 50 patients will be switched to vortioxetine due to inadequate response to the current antidepressant medication treatment (switch patients).

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Vortioxetine

Experimental group

Description:

10-20 mg vortioxetine tablets

Treatment:

Drug: Vortioxetine