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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Phase: N/A

Status: Active, not recruiting

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Tatiana Vladimirova, MD, PhD, Study Director, Affiliation: Abbott

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.

Clinical Details

Official title: Post-Marketing Observational Program of Fevarin« Effectiveness in Treatment of Depression in Patients With Neurological Disorders (FRIENDS)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Prevalence of different neurological disorders associated with depression treated with fluvoxamine (Fevarin®).

Secondary outcome:

Demographics of patients (age, gender, race, family status, education, employment).

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

Number and proportion of patients with depression symptoms change measured by Hospital Anxiety and Depression Scale (HADS)

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

Global severity of illness and change in the clinical condition measured by Clinical Global Impression scale

Number and proportion of patients with change in Clinical Global Impression scale

Anxiety and depression symptoms score measured by Hospital Anxiety and Depression Scale (HADS)

Number and proportion of patients with anxiety symptoms change measured by Hospital Anxiety and Depression Scale (HADS)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients with neurological disorders and mild or moderate symptoms of depression

with 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.

Locations and Contacts

Research Facility ID ORG-000890, Chelyabinsk 454080, Russian Federation

Research facilility ID ORG-000872, Ekaterinburg 620141, Russian Federation

Research facility ID ORG-000875, Essentuki 357601, Russian Federation

Research facility ID ORG-000881, Krasnoyarsk 660037, Russian Federation

Research facility ID ORG-000876, Moscow 127644, Russian Federation

Research facility ID ORG-000877, Moscow 129110, Russian Federation

Research facility ID ORG-000882, Moscow 119435, Russian Federation

Research facility ID ORG-000893, Moscow 117342, Russian Federation

Research Facility ID ORG-000889, Nizhny Novgorod 603006, Russian Federation

Research facility ID ORG-000880, Novosibirsk 630991, Russian Federation

Research Facility ID ORG-000879, Penza 440034, Russian Federation

Research facility ID ORG-000840, Perm 614010, Russian Federation

Research facility ID ORG-000891, Perm 614000, Russian Federation

Research Facility ID ORG-000873, Primorskiy kray, Spassk-Dalniy 692237, Russian Federation

Research facility ID ORG-000803, Rostov-on-Don 344000, Russian Federation

Research facility ID ORG-000894, Rostov-on-Don 344015, Russian Federation

Research facility ID ORG-000898, Rostov-on-Don 344010, Russian Federation

Research facility ID ORG-001027, Rostov-on-Don 344011, Russian Federation

Research facility ID ORG-001028, Rostov-on-Don 344010, Russian Federation

Research facility ID ORG-000897, Samara 443110, Russian Federation

Research facility ID ORG-000839, Saratov 410012, Russian Federation

Research facility ID ORG-000892, St. Petersburg 194044, Russian Federation

Research facility ID ORG-000896, St. Petersburg 193312, Russian Federation

Research facility ID ORG-000965, St. Petersburg 197022, Russian Federation

Research Facility ID ORG-000878, Tver 170036, Russian Federation

Research facility ID ORG-001026, Vladivostok 690024, Russian Federation

Research Facility ID ORG-000874, Volgograd 400007, Russian Federation

Research Facility ID ORG-000888, Volgograd 400009, Russian Federation

Research Facility ID ORG-000895, Voronezh 394066, Russian Federation

Additional Information

Starting date: January 2014
Last updated: June 15, 2015

Page last updated: August 23, 2015

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