Clinical trial NCT02043197: Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorder
Official title: Post-Marketing Observational Program of Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorders (FRIENDS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Depression,
depressive symptoms,
major depressive disorder,
Fevarine,
fluvoxamine,
cognitive function,
neurological disorders,
sleep state
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Manipal Acunova Ltd.
First posted: 2014-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinics

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®).
timeFrame: Baseline
Secondary outcomes:
measure: Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
timeFrame: From Baseline up to Day 30 and Day 90
measure: Percent of Patients With Change of Depression Symptoms From Baseline to Day 30
timeFrame: From Baseline up to Day 30
measure: Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
timeFrame: From Baseline up to Day 30 and Day 90
measure: Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale
timeFrame: Baseline, Day 90
measure: Percent of Patients With Change in Clinical Global Impression Scale
timeFrame: From Baseline up to Day 90
measure: Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Up to 180 days
measure: Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.
timeFrame: From Baseline up to Day 30
measure: Gender
timeFrame: Baseline
measure: Race
timeFrame: Baseline
measure: Family Status
timeFrame: Baseline
measure: Education
timeFrame: Baseline
measure: Employment
timeFrame: Baseline
Other outcomes:
measure: Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline, Day 90, Up to 180 days
measure: Insomnia Severity Index
timeFrame: Baseline, Day 90, Up to 180 days
measure: Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90
timeFrame: From baseline up to Day 90
measure: Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale From Day 90 to 180 Days
timeFrame: From Day 90 up to Up to 180 days
measure: Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180
timeFrame: From Day 90 up to 180 days
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Research Facility ID ORG-000890
city: Ekaterinburg
country: Russian Federation
facility: Research facilility ID ORG-000872
city: Krasnoyarsk
country: Russian Federation
facility: Research facility ID ORG-000881
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-000893
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-000882
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-000876
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-000877
city: Nizhny Novgorod
country: Russian Federation
facility: Research Facility ID ORG-000889
city: Novosibirsk
country: Russian Federation
facility: Research facility ID ORG-000880
city: Penza
country: Russian Federation
facility: Research Facility ID ORG-000879
city: Perm
country: Russian Federation
facility: Research facility ID ORG-000891
city: Perm
country: Russian Federation
facility: Research facility ID ORG-000840
city: Rostov-on-Don
country: Russian Federation
facility: Research facility ID ORG-000803
city: Rostov-on-Don
country: Russian Federation
facility: Research facility ID ORG-000898
city: Rostov-on-Don
country: Russian Federation
facility: Research facility ID ORG-001028
city: Rostov-on-Don
country: Russian Federation
facility: Research facility ID ORG-001027
city: Rostov-on-Don
country: Russian Federation
facility: Research facility ID ORG-000894
city: Samara
country: Russian Federation
facility: Research facility ID ORG-000897
city: Saratov
country: Russian Federation
facility: Research facility ID ORG-000839
city: Spassk-Dal'niy
country: Russian Federation
facility: Research Facility ID ORG-000873
city: St. Petersburg
country: Russian Federation
facility: Research facility ID ORG-000896
city: St. Petersburg
country: Russian Federation
facility: Research facility ID ORG-000892
city: St. Petersburg
country: Russian Federation
facility: Research facility ID ORG-000965
city: Tver
country: Russian Federation
facility: Research Facility ID ORG-000878
city: Vladivostok
country: Russian Federation
facility: Research facility ID ORG-001026
city: Volgograd
country: Russian Federation
facility: Research Facility ID ORG-000874
city: Volgograd
country: Russian Federation
facility: Research Facility ID ORG-000888
city: Voronezh
country: Russian Federation
facility: Research Facility ID ORG-000895
city: Yessentuki
country: Russian Federation
facility: Research facility ID ORG-000875
Study officials:
affiliation: Abbott
name: Tatiana Vladimirova, MD, PhD
role: STUDY_DIRECTOR
References: