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

NCT ID: NCT02043197

Last Updated: 2018-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Depression

Keywords

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Depression, depressive symptoms, major depressive disorder, Fevarine, fluvoxamine, cognitive function, neurological disorders, sleep state

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Outpatients with neurological disorders and depression.

Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manipal Acunova Ltd.

NETWORK

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tatiana Vladimirova, MD, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

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Research Facility ID ORG-000890

Chelyabinsk, , Russia

Site Status

Research facility ID ORG-000881

Krasnoyarsk, , Russia

Site Status

Research facility ID ORG-000893

Moscow, , Russia

Site Status

Research facility ID ORG-000882

Moscow, , Russia

Site Status

Research facility ID ORG-000876

Moscow, , Russia

Site Status

Research facility ID ORG-000877

Moscow, , Russia

Site Status

Research Facility ID ORG-000889

Nizhny Novgorod, , Russia

Site Status

Research facility ID ORG-000880

Novosibirsk, , Russia

Site Status

Research Facility ID ORG-000879

Penza, , Russia

Site Status

Research facility ID ORG-000891

Perm, , Russia

Site Status

Research facility ID ORG-000840

Perm, , Russia

Site Status

Research facility ID ORG-000803

Rostov-on-Don, , Russia

Site Status

Research facility ID ORG-000898

Rostov-on-Don, , Russia

Site Status

Research facility ID ORG-001028

Rostov-on-Don, , Russia

Site Status

Research facility ID ORG-001027

Rostov-on-Don, , Russia

Site Status

Research facility ID ORG-000894

Rostov-on-Don, , Russia

Site Status

Research facility ID ORG-000896

Saint Petersburg, , Russia

Site Status

Research facility ID ORG-000892

Saint Petersburg, , Russia

Site Status

Research facility ID ORG-000965

Saint Petersburg, , Russia

Site Status

Research facility ID ORG-000897

Samara, , Russia

Site Status

Research facility ID ORG-000839

Saratov, , Russia

Site Status

Research Facility ID ORG-000873

Spassk-Dal'niy, , Russia

Site Status

Research Facility ID ORG-000878

Tver', , Russia

Site Status

Research facility ID ORG-001026

Vladivostok, , Russia

Site Status

Research Facility ID ORG-000874

Volgograd, , Russia

Site Status

Research Facility ID ORG-000888

Volgograd, , Russia

Site Status

Research Facility ID ORG-000895

Voronezh, , Russia

Site Status

Research facilility ID ORG-000872

Yekaterinburg, , Russia

Site Status

Research facility ID ORG-000875

Yessentuki, , Russia

Site Status

Countries

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Russia

Other Identifiers

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P14-326

Identifier Type: -

Identifier Source: org_study_id