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.
Study Type
OBSERVATIONAL
Enrollment
300
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.
Time frame: Baseline
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
Time frame: From Baseline up to Day 30 and Day 90
Percent of Patients With Change of Depression Symptoms From Baseline to Day 30
Time frame: 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
Time frame: 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
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Research Facility ID ORG-000890
Chelyabinsk, Russia
Research facility ID ORG-000881
Krasnoyarsk, Russia
Research facility ID ORG-000893
Moscow, Russia
Research facility ID ORG-000882
Moscow, Russia
Research facility ID ORG-000876
Moscow, Russia
Research facility ID ORG-000877
Moscow, Russia
Research Facility ID ORG-000889
Nizhny Novgorod, Russia
Research facility ID ORG-000880
Novosibirsk, Russia
Research Facility ID ORG-000879
Penza, Russia
Research facility ID ORG-000891
Perm, Russia
...and 19 more locations
Time frame: Baseline, Day 90
Percent of Patients With Change in Clinical Global Impression Scale
Time frame: 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
Time frame: Up to 180 days
Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.
Time frame: From Baseline up to Day 30
Gender
Time frame: Baseline
Race
Time frame: Baseline
Family Status
Time frame: Baseline
Education
Time frame: Baseline
Employment
Time frame: Baseline