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

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

Detailed Description
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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).

Official Title
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Interventional, Open-label Effectiveness Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder Comorbid With Generalized Anxiety Disorder

Conditions
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MDD, Anxiety Disorders

Intervention / Treatment
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* Drug: Vortioxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vortioxetine<br>10-20 mg vortioxetine tablets | Drug: Vortioxetine<br>* Vortioxetine 10 and 20 mg/day, tablets, orally Patients will receive 10 mg vortioxetine once daily for the first week. At Visit 2, the dose will be increased to 20 mg/day. The dose may subsequently be adjusted to 10 or 20 mg/day at scheduled or unscheduled visits depending on patient's response as per investigator judgment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score | The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. | from baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Anxiety Rating Scale (HAM-A) total score | The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 indicate very severe anxiety. | from baseline to Week 8 | 
| Change in Hospital Anxiety and Depression Scale (HADS) total score | The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21. | from baseline to Week 8 | 
| Change in Functioning Assessment Short Test (FAST) total score | The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. Each item is rated on a 4-point scale from 0 (no difficulty) to 3 (severe difficulty). The items are summed to yield a total score ranging from 0 to 72 with higher scores reflecting more serious difficulties. | from baseline to Week 8 | 
| Change in Clinical Global Impression - Severity of Illness (CGI-S) score | The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). | from baseline to Week 8 | 
| Clinical Global Impression Scale- Global Improvement (CGI-I) score | The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | At Week 8 | 
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score | The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). | from baseline to Week 8 |