Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorder (FRIENDS)

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

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 Overview

• Status: Completed
• Conditions: Depression

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 454080
    • Research Facility ID ORG-000890
  • Ekaterinburg, Russian Federation, 620141
    • Research facilility ID ORG-000872
  • Krasnoyarsk, Russian Federation, 660037
    • Research facility ID ORG-000881
  • Moscow, Russian Federation, 117342
    • Research facility ID ORG-000893
  • Moscow, Russian Federation, 119435
    • Research facility ID ORG-000882
  • Moscow, Russian Federation, 127644
    • Research facility ID ORG-000876
  • Moscow, Russian Federation, 129110
    • Research facility ID ORG-000877
  • Nizhny Novgorod, Russian Federation, 603006
    • Research Facility ID ORG-000889
  • Novosibirsk, Russian Federation, 630991
    • Research facility ID ORG-000880
  • Penza, Russian Federation, 440034
    • Research Facility ID ORG-000879
  • Perm, Russian Federation, 614000
    • Research facility ID ORG-000891
  • Perm, Russian Federation, 614010
    • Research facility ID ORG-000840
  • Rostov-on-Don, Russian Federation, 344000
    • Research facility ID ORG-000803
  • Rostov-on-Don, Russian Federation, 344010
    • Research facility ID ORG-000898
  • Rostov-on-Don, Russian Federation, 344010
    • Research facility ID ORG-001028
  • Rostov-on-Don, Russian Federation, 344011
    • Research facility ID ORG-001027
  • Rostov-on-Don, Russian Federation, 344015
    • Research facility ID ORG-000894
  • Samara, Russian Federation, 443110
    • Research facility ID ORG-000897
  • Saratov, Russian Federation, 410012
    • Research facility ID ORG-000839
  • Spassk-Dal'niy, Russian Federation, 692237
    • Research Facility ID ORG-000873
  • St. Petersburg, Russian Federation, 193312
    • Research facility ID ORG-000896
  • St. Petersburg, Russian Federation, 194044
    • Research facility ID ORG-000892
  • St. Petersburg, Russian Federation, 197022
    • Research facility ID ORG-000965
  • Tver, Russian Federation, 170036
    • Research Facility ID ORG-000878
  • Vladivostok, Russian Federation, 690024
    • Research facility ID ORG-001026
  • Volgograd, Russian Federation, 400007
    • Research Facility ID ORG-000874
  • Volgograd, Russian Federation, 400009
    • Research Facility ID ORG-000888
  • Voronezh, Russian Federation, 394066
    • Research Facility ID ORG-000895
  • Yessentuki, Russian Federation, 357601
    • Research facility ID ORG-000875

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care clinics

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Outpatients with neurological disorders and depression.; Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.

What is the study measuring?

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
Gender		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	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
Race		Baseline
Family Status		Baseline
Education		Baseline
Employment		Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Manipal Acunova Ltd.
• Investigators: Study Director: Tatiana Vladimirova, MD, PhD, Abbott

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: January 20, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: cognitive function,; sleep state; major depressive disorder,; Depression,; depressive symptoms,; Fevarine,; fluvoxamine,; neurological disorders,
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Nervous System Diseases
• Other Study ID Numbers: P14-326