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Multicenter study on the antidepressant effect of istradefylline for Parkinson's disease

Multicenter study on the antidepressant effect of istradefylline for Parkinson's disease - Multicenter study on the antidepressant effect of istradefylline for Parkinson's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022021
Enrollment
60
Registered
2016-04-21
Start date
2016-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson&#39

Interventions

Oral administration of istradefilline 20mg / day for 12-week. If the improvement of wearing off is insufficient after 4 weeks, it is possible to increased to 40mg / day.

Sponsors

Nippon Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients who have akinesia with regidity or tremor and diagnosed as Parkinson's disease. The patients presenting wearing-off phenomenon. The patients with 3 points or more in Snaith-Hamilton Pleasure Scale Japanese version or 16 points or more in Apathy Scale or 14 points or more in Beck Depression Inventory-II. The patients with 23 points or more in Mini Mental State Examination.

Exclusion criteria

Exclusion criteria: The patients who are expected to change anti-parkinsonian drugs during the study. The patients who have marked psychiatric fluctuation. The patients who take the following agents: ketoconazole, Rifampicin, midazolam, atorvastatin or digoxin. The patients with current smoker.

Design outcomes

Primary

MeasureTime frame
The changes of score in depresion-related-scales.

Secondary

MeasureTime frame
The changes of score in Parkinson's disease disease-related-scales.

Countries

Japan

Contacts

Public ContactHiroshi Nagayama

Nippon Medical School Neurology

nagayama@nms.ac.jp03-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026