Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders:...
Yahno N. N., Fedotova A. V.
Neuropsychiatric Disease and Treatment
Vol.13, P. 2747-2756
Опубликовано: 2017
Тип ресурса: Статья
Аннотация:
In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50–300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale). The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296) was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant (P<0.0001) improvements in both scores were recorded during fluvoxamine treatment and later follow-up. Most patients (>85[%]) recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200) experienced moderate t
Ключевые слова:
Anxiety; Cognitive function; Depression; Fluvoxamine; Neurological disease; Sleep
fluvoxamine; valproic acid; adult; aged; anxiety; Article; asthenia; Clinical Global Impression scale; clinical trial; cognition; comorbidity; depression; dizziness; drug efficacy; drug safety; drug tolerability; drug withdrawal; female; headache; Hospital Anxiety and Depression Scale; human; hyperkinesia; Insomnia Severity Index; major clinical study; male; Montreal cognitive assessment; multicenter study; nausea; neurologic disease; observational study; open study; postmarketing surveillance; prospective study; Russian Federation; side effect; sleep quality; somnolence
Язык текста: Английский
ISSN: 1178-2021
Yahno N. N.
Fedotova A. V.
Яхно Н. Н.
Федотова А. В.
Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: The friends study
Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders:...
Текст визуальный непосредственный
Neuropsychiatric Disease and Treatment
Dove Medical Press Ltd.
Vol.13 P. 2747-2756
2017
Статья
Anxiety Cognitive function Depression Fluvoxamine Neurological disease Sleep
fluvoxamine valproic acid adult aged anxiety Article asthenia Clinical Global Impression scale clinical trial cognition comorbidity depression dizziness drug efficacy drug safety drug tolerability drug withdrawal female headache Hospital Anxiety and Depression Scale human hyperkinesia Insomnia Severity Index major clinical study male Montreal cognitive assessment multicenter study nausea neurologic disease observational study open study postmarketing surveillance prospective study Russian Federation side effect sleep quality somnolence
In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50–300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale). The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296) was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant (P<0.0001) improvements in both scores were recorded during fluvoxamine treatment and later follow-up. Most patients (>85[%]) recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200) experienced moderate t