Back to Search
Start Over
A Randomized, Placebo-Controlled, Double-Blind Efficacy Study of Nefiracetam to Treat Poststroke Apathy
A Randomized, Placebo-Controlled, Double-Blind Efficacy Study of Nefiracetam to Treat Poststroke Apathy
- Source :
- Journal of Stroke and Cerebrovascular Diseases. 25:1119-1127
- Publication Year :
- 2016
- Publisher :
- Elsevier BV, 2016.
-
Abstract
- Background To evaluate the efficacy of treatment with nefiracetam compared to placebo in poststroke apathy. Methods A parallel group, randomized, placebo-controlled, double-blind two-center trial in patients with recent stroke and apathy was conducted in 2 tertiary teaching hospitals in Perth, Western Australia, between March 2010 and October 2014. Consenting patients hospitalized with stroke were screened for participation at the time of hospitalization and, if diagnosed with apathy 8-36 weeks later, they were randomized to 12 weeks of 900 mg/day nefiracetam or placebo. The primary efficacy parameter was change in apathy at 12 weeks defined by the 14-item Apathy Scale (AS). Results Of 2514 patients screened, only 377 (15%) were eligible for the study after the first screening, 233 declined further participation, and 144 were assessed for apathy at 8-36 weeks post stroke to confirm eligibility. Twenty patients out of 106 with a complete psychiatric assessment had apathy (19%). Of this sample, 13 patients were randomized. Overall, the AS score decreased by a mean of 7.0 points (95% CI = −14.6 to .6), but there was no significant between-group difference at week 12 (mean paired t -tests, P > .14). Conclusions Treatment with nefiracetam did not prove to be more efficacious than placebo in ameliorating apathy in stroke. The main limitation was the very small sample randomized, highlighting the limitations of conducting drug trials for behavioral problems among stroke patients. Pharmacological studies of apathy in stroke will require a large multicenter study and a massive sample of patients.
- Subjects :
- Male
medicine.medical_specialty
Time Factors
Apathy
Neuropsychological Tests
Placebo
Tertiary Care Centers
Double blind
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Surveys and Questionnaires
medicine
Humans
030212 general & internal medicine
Hospitals, Teaching
Stroke
Nootropic Agents
Depression (differential diagnoses)
Aged
Psychiatric Status Rating Scales
business.industry
Psychiatric assessment
Rehabilitation
Western Australia
Middle Aged
medicine.disease
Pyrrolidinones
Treatment Outcome
Nefiracetam
Physical therapy
Female
Surgery
Neurology (clinical)
medicine.symptom
Cardiology and Cardiovascular Medicine
business
030217 neurology & neurosurgery
Efficacy Study
medicine.drug
Subjects
Details
- ISSN :
- 10523057
- Volume :
- 25
- Database :
- OpenAIRE
- Journal :
- Journal of Stroke and Cerebrovascular Diseases
- Accession number :
- edsair.doi.dedup.....c88c04b66fb3859714fa6a85f59fc766
- Full Text :
- https://doi.org/10.1016/j.jstrokecerebrovasdis.2016.01.032