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

Phase 1

• Conditions: Depressive symptoms in patients with major depressive disorder (MDD) comorbid with generalized anxiety disorder (GAD); MedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-001325-27-IT
• Lead Sponsor: H. LUNDBECK A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effectiveness of 8-week acute treatment with 10–20 mg/day vortioxetine on depressive symptoms in patients with major depressive disorder (MDD) comorbid with generalized anxiety disorder (GAD).<br>;Secondary Objective: To assess the effectiveness of vortioxetine on:<br>• anxiety symptoms<br>• functioning <br>• global clinical impression<br>• health-related quality of life ;Primary end point(s): Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score;Timepoint(s) of evaluation of this end point: From baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Change in Hamilton Anxiety Rating Scale (HAM-A) total score*<br>• Change in Hospital Anxiety and Depression Scale (HADS) total score*<br>• Change in Functioning Assessment Short Test (FAST) total score* <br>• Change in Clinical Global Impression - Severity of Illness (CGI-S) score*<br>• Clinical Global Impression Scale- Global Improvement (CGI-I) score**<br>• Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score*;Timepoint(s) of evaluation of this end point: *) From baseline to Week 8<br>**) At Week 8