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

Completed

Conditions: Depression

Registration Number: NCT02043197

Lead Sponsor: Abbott

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®).	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
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	From Baseline up to Day 30 and Day 90	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
Percent of Patients With Change in Clinical Global Impression Scale	From Baseline up to Day 90
Family Status	Baseline
Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.	From Baseline up to Day 30
Gender	Baseline
Race	Baseline
Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale	Baseline, Day 90	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
Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score	From Baseline up to Day 30 and Day 90	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
Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS)	Up to 180 days	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
Education	Baseline
Employment	Baseline

Trial Locations

Locations (29): Research facility ID ORG-000897
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Samara, Russian Federation
Research facility ID ORG-000898
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Rostov-on-Don, Russian Federation
Research facility ID ORG-000840
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Perm, Russian Federation
Research Facility ID ORG-000879
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Penza, Russian Federation
Research facility ID ORG-000891
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Perm, Russian Federation
Research Facility ID ORG-000889
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Nizhny Novgorod, Russian Federation
Research facility ID ORG-000803
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Rostov-on-Don, Russian Federation
Research facility ID ORG-000880
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Novosibirsk, Russian Federation
Research facility ID ORG-001026
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Vladivostok, Russian Federation
Research facility ID ORG-001028
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Rostov-on-Don, Russian Federation
Research facility ID ORG-000965
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St. Petersburg, Russian Federation
Research Facility ID ORG-000878
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Tver, Russian Federation
Research facility ID ORG-001027
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Rostov-on-Don, Russian Federation
Research Facility ID ORG-000895
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Voronezh, Russian Federation
Research Facility ID ORG-000890
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Chelyabinsk, Russian Federation
Research facilility ID ORG-000872
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Ekaterinburg, Russian Federation
Research facility ID ORG-000881
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Krasnoyarsk, Russian Federation
Research facility ID ORG-000877
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Moscow, Russian Federation
Research facility ID ORG-000893
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Moscow, Russian Federation
Research facility ID ORG-000882
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Moscow, Russian Federation
Research facility ID ORG-000876
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Moscow, Russian Federation
Research facility ID ORG-000894
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Rostov-on-Don, Russian Federation
Research facility ID ORG-000839
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Saratov, Russian Federation
Research Facility ID ORG-000873
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Spassk-Dal'niy, Russian Federation
Research facility ID ORG-000896
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St. Petersburg, Russian Federation
Research facility ID ORG-000892
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St. Petersburg, Russian Federation
Research Facility ID ORG-000874
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Volgograd, Russian Federation
Research Facility ID ORG-000888
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Volgograd, Russian Federation
Research facility ID ORG-000875
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Yessentuki, Russian Federation