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

Depression Clinical Trial

— FRIENDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043197
• Other study ID #: P14-326
• Status: Completed
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: June 2018
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Nervous System Diseases

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Manipal Acunova Ltd.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA)	MoCA test used under license agreement www.mocatest.org; Scale range 0-30 Normal >=26 Higher values represent a better outcome	Baseline, Day 90, Up to 180 days
Other	Insomnia Severity Index	Insomnia Severity Index (ISI) used under license agreement cmorin@psy.ulaval.ca; Total score has the range from 0 to 28 points with the following categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe). Higher values represent a worse outcome	Baseline, Day 90, Up to 180 days
Other	Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90	Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) From Baseline to Day 90.	From baseline up to Day 90
Other	Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale From Day 90 to 180 Days	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	From Day 90 up to Up to 180 days
Other	Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180	Global improvement - qualitative scale 0 = Not assessed, 1 = Very much improved , 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse	From Day 90 up to 180 days
Primary	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	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
Secondary	Percent of Patients With Change of Depression Symptoms From Baseline to Day 30		From Baseline up to Day 30
Secondary	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
Secondary	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
Secondary	Percent of Patients With Change in Clinical Global Impression Scale		From Baseline up to Day 90
Secondary	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
Secondary	Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.		From Baseline up to Day 30
Secondary	Gender		Baseline
Secondary	Race		Baseline
Secondary	Family Status		Baseline
Secondary	Education		Baseline
Secondary	Employment		Baseline