Depressive symptoms in patients with major depressive disorder (MDD) comorbid with generalized anxiety disorder (GAD) MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;Secondary Objective: To assess the effectiveness of vortioxetine on: • anxiety symptoms • functioning • global clinical impression • 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in Hamilton Anxiety Rating Scale (HAM-A) total score* • Change in Hospital Anxiety and Depression Scale (HADS) total score* • Change in Functioning Assessment Short Test (FAST) total score* • Change in Clinical Global Impression - Severity of Illness (CGI-S) score* • Clinical Global Impression Scale- Global Improvement (CGI-I) score** • 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 **) At Week 8 | — |
Countries
Estonia, Finland, France, Italy, Korea, Republic of, Spain, Switzerland
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed