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Effect of Duloxetine on inflammation and motor symptoms in patients with Parkinson's disease

Effect of administration of Duloxetine on inflammatory cytokines and motor symptoms in patients with Parkinson's disease - open-label study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5nryr5
Enrollment
Unknown
Registered
2018-10-10
Start date
2017-12-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Parkinson's disease

Interventions

The study evaluates the effect of duloxetine administration on neuroinflammation through serum gamma INF, IL-6, IL-1 beta, IL-10 and TNF-alpha in 17 patients with Parkinson's disease, in addition to e
Drug
G07.690.773.875

Sponsors

Universidade Federal de Santa Maria
Lead Sponsor
Hospital Universitário de Santa Maria
Collaborator
Universidade Federal de Santa Maria
Collaborator

Eligibility

Age
40 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age older than 40 years, thus excluding early Parkinson's Disease; with diagnosis of Parkinson's Disease; using levodopa; for at least two weeks without antidepressants; with a Free and Informed Consent Term read and signed.

Exclusion criteria

Exclusion criteria: If they had dementia, glaucoma or major depression; if they suffered from heart, kidney or liver disease; if they had poorly controlled blood pressure; if they suffered from rheumatological diseases.

Design outcomes

Primary

MeasureTime frame
Motor improvement demonstrated by reducing total UPRDS score after 4 and 8 weeks of treatment with duloxetine.—

Secondary

MeasureTime frame
Secondary outcome 1: reduction in the scores of each part of the UPDRS scale. Part I (cognition, behavior and mood), part II (activities of daily living) and part III (motor examination) ;Secondary outcome 2: improvement in patients' quality of life verified by the reduction of scores of 39 items of the Parkinson's Disease Questionnaire (PDQ-39) questionnaire.;Secondary outcome 3: reduction of neuroinflammation verified by serum levels of interleukin 1 beta, interleukin 6, interleukin 10, tumor necrosis factor alpha, interferon gamma, with reduction of serum levels.—

Countries

Brazil

Contacts

Public ContactCarlos;Juliana Mello;Oliveira Freitas Silveira

Universidade Federal de Santa Maria;Hospital Universitário de Santa Maria

mello.cf@gmail.com;julianaofs@yahoo.com.br55 55 32208342;55 55 32131400

Outcome results

None listed

Source: REBEC (via WHO ICTRP)