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

NCT02043197 | Completed Results

• 1 other identifier: P14-326
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 29

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.

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

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

  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

  From Baseline up to Day 30 and Day 90

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

  Baseline, Day 90

• Percent of Patients With Change in Clinical Global Impression Scale

  From Baseline up to Day 90

Other Outcomes (5)

• Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA)

  Baseline, Day 90, Up to 180 days

• Insomnia Severity Index

  Baseline, Day 90, Up to 180 days

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

  From baseline up to Day 90

Study Arms (1)

Outpatients with neurological disorders and depression.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinics

You may qualify if:

• 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.

You may not qualify if:

• Labeled contraindications to Fevarin®, psychotic symptoms and/or suicidal ideation, schizophrenia, bipolar disorder, schizoaffective disorder, severe dementia, alcohol or drug abuse, acute neurological disorders.

Sponsors & Collaborators

• Abbott: lead
• Manipal Acunova Ltd.: collaborator

Study Sites (29)

Research Facility ID ORG-000890

Chelyabinsk, 454080, Russia

Location

Research facility ID ORG-000881

Krasnoyarsk, 660037, Russia

Location

Research facility ID ORG-000893

Moscow, 117342, Russia

Location

Research facility ID ORG-000882

Moscow, 119435, Russia

Location

Research facility ID ORG-000876

Moscow, 127644, Russia

Location

Research facility ID ORG-000877

Moscow, 129110, Russia

Location

Research Facility ID ORG-000889

Nizhny Novgorod, 603006, Russia

Location

Research facility ID ORG-000880

Novosibirsk, 630991, Russia

Location

Research Facility ID ORG-000879

Penza, 440034, Russia

Location

Research facility ID ORG-000891

Perm, 614000, Russia

Location

Research facility ID ORG-000840

Perm, 614010, Russia

Location

Research facility ID ORG-000803

Rostov-on-Don, 344000, Russia

Location

Research facility ID ORG-000898

Rostov-on-Don, 344010, Russia

Location

Research facility ID ORG-001028

Rostov-on-Don, 344010, Russia

Location

Research facility ID ORG-001027

Rostov-on-Don, 344011, Russia

Location

Research facility ID ORG-000894

Rostov-on-Don, 344015, Russia

Location

Research facility ID ORG-000896

Saint Petersburg, 193312, Russia

Location

Research facility ID ORG-000892

Saint Petersburg, 194044, Russia

Location

Research facility ID ORG-000965

Saint Petersburg, 197022, Russia

Location

Research facility ID ORG-000897

Samara, 443110, Russia

Location

Research facility ID ORG-000839

Saratov, 410012, Russia

Location

Research Facility ID ORG-000873

Spassk-Dal'niy, 692237, Russia

Location

Research Facility ID ORG-000878

Tver', 170036, Russia

Location

Research facility ID ORG-001026

Vladivostok, 690024, Russia

Location

Research Facility ID ORG-000874

Volgograd, 400007, Russia

Location

Research Facility ID ORG-000888

Volgograd, 400009, Russia

Location

Research Facility ID ORG-000895

Voronezh, 394066, Russia

Location

Research facilility ID ORG-000872

Yekaterinburg, 620141, Russia

Location

Research facility ID ORG-000875

Yessentuki, 357601, Russia

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Nervous System Diseases

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Tatiana V. Vladimirova
• Organization: Abbott

tatiana.vladimirova@abbott.com

+74952584280

Study Officials

• Tatiana Vladimirova, MD, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: January 23, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 17, 2018
• Results First Posted: December 17, 2018

Record last verified: 2018-06

Locations

RU (29)