Depression | Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorder
Depression research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Outpatients with neurological disorders and depression.Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Start Date: January 2014
Completed Date: November 2015
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).
Study sponsors, principal investigator, and references
Principal Investigator: Tatiana Vladimirova, MD, PhD
Lead Sponsor: Abbott
Collaborator: Manipal Acunova Ltd.