Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorder

Study Overview
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Brief Summary
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Prospective, multicenter, non-comparative, observational program to describe prevalence of depressive symptoms in a variety of neurological disorders and effects of Fevarin® on the severity of anxiety and depression, sleep state, and cognitive function.

Official Title
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Post-Marketing Observational Program of Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorders (FRIENDS)

Conditions
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Depression

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with neurological disorders and mild or moderate symptoms of depression with Hospital Anxiety Depression Scale (HADS) depression scale score of 8 and higher. Fevarin® prescribed not earlier than 7 days before Visit 1. Exclusion Criteria: Labeled contraindications to Fevarin®, psychotic symptoms and/or suicidal ideation, schizophrenia, bipolar disorder, schizoaffective disorder, severe dementia, alcohol or drug abuse, acute neurological disorders.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatients with neurological disorders and depression.<br>Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). | The primary neurologic diagnosis was coded according to International Classification of Diseases and Related Health Problems, revision 10 http://apps.who.int/classifications/icd10/browse/2010/en In the report all diseases were summarized by Classes. Percentage of patients reporting at least once a specified symptom during the treatment period. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score | HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/ The scale have two subscales: HADS-Anxiety HADS-Depression Each subscale has range 0-21 with following interpretation: 0-7 normal 8-10 mild 11-14 moderate 15-21 severe In this place 'Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score' is presented | From Baseline up to Day 30 and Day 90 | 
| Percent of Patients With Change of Depression Symptoms From Baseline to Day 30 |  | From Baseline up to Day 30 | 
| Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score | HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/ The scale have two subscales: HADS-Anxiety HADS-Depression Each subscale has range 0-21 with following interpretation: 0-7 normal 8-10 mild 11-14 moderate 15-21 severe In this place 'Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score' is presented | From Baseline up to Day 30 and Day 90 | 
| Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale | Clinical Global Impression Scale (CGI) was used. CGI is in the public domain. Severity of illness is the subscale of Clinical Global Impression (CGI). Severity of illness - reported in this place 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients | Baseline, Day 90 | 
| Percent of Patients With Change in Clinical Global Impression Scale |  | From Baseline up to Day 90 | 
| Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS) | HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/ The scale have two subscales: HADS-Anxiety HADS-Depression Each subscale has range 0-21 with following interpretation: 0-7 normal 8-10 mild 11-14 moderate 15-21 severe In this place Change in the Hospital Anxiety and Depression Scale (HADS) Both Subscale Scores are presented assessed at Day 180 | Up to 180 days | 
| Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30. |  | From Baseline up to Day 30 | 
| Gender |  | Baseline | 
| Race |  | Baseline | 
| Family Status |  | Baseline | 
| Education |  | Baseline | 
| Employment |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression,, depressive symptoms,, major depressive disorder,, Fevarine,, fluvoxamine,, cognitive function,, neurological disorders,, sleep state