N/A
N=300
Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorder
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02043197 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). — 49.2; 31.8; 20.1; 2.7 Percentage
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). |
49.2; 31.8; 20.1; 2.7 | — |
| SECONDARY Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score |
-3; -6 | — |
| SECONDARY Percent of Patients With Change of Depression Symptoms From Baseline to Day 30 |
88.2; 2.7; 9.1 | — |
| SECONDARY Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score |
-3.4; -6.5 | — |
| SECONDARY Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale |
-1 | — |
| SECONDARY Percent of Patients With Change in Clinical Global Impression Scale |
38.1; 46.9; 11.2; 2.4; 0.3; 0.3 | — |
| SECONDARY Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS) |
4.2; 4.7 | — |
| SECONDARY Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30. |
89.9; 2.7; 7.4 | — |
| SECONDARY Gender |
73.24; 26.76 | — |
| SECONDARY Race |
0.7; 99.3 | — |
| SECONDARY Family Status |
1; 5.4; 65.9; 15.7; 12 | — |
| SECONDARY Education |
3; 33.8; 63.2 | — |
| SECONDARY Employment |
62.5; 37.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02043197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.