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Completed

NCT Number: NCT02043197

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Facility ID ORG-000890, Chelyabinsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®).

    Time frame: 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 outcomes

  1. Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score

    Time frame: 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

  2. Percent of Patients With Change of Depression Symptoms From Baseline to Day 30

    Time frame: From Baseline up to Day 30

  3. Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score

    Time frame: 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

  4. Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale

    Time frame: 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

  5. Percent of Patients With Change in Clinical Global Impression Scale

    Time frame: From Baseline up to Day 90

  6. Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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

  7. Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.

    Time frame: From Baseline up to Day 30

  8. Gender

    Time frame: Baseline

  9. Race

    Time frame: Baseline

  10. Family Status

    Time frame: Baseline

  11. Education

    Time frame: Baseline

  12. Employment

    Time frame: Baseline

Other outcomes

  1. Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA)

    Time frame: Baseline, Day 90, Up to 180 days

    MoCA test used under license agreement www.mocatest.org

    Scale range 0-30 Normal >=26 Higher values represent a better outcome

  2. Insomnia Severity Index

    Time frame: Baseline, Day 90, Up to 180 days

    Insomnia Severity Index (ISI) used under license agreement [email protected]

    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

  3. Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90

    Time frame: From baseline up to Day 90

    Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) From Baseline to Day 90.

  4. Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale From Day 90 to 180 Days

    Time frame: From Day 90 up to Up 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

  5. Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180

    Time frame: From Day 90 up to 180 days

    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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Manipal Acunova Ltd.

Registry information

Official study title

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

Acronym: FRIENDS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2014
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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