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The effect of the drug Trazodone on motor symptoms of Parkinson's Disease.

Motors Effects in Parkinson's Disease by the action of 5-HT2a/c antagonistic drug mediated by ELF2-alpha factor phosphorylation pathway in humans. A Double-Blind Randomized Controlled Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4b32m3
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-07-10
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 Disease

Interventions

Up to 30 subjects are estimated to participate in the study, divided into two arms (intervention and placebo). The intervention patients will be prescribed the initial use of 1 (one) 50mg tablet of tr
Drug

Sponsors

Universidade Federal da Integração Latino-Americana do Brasil (UNILA).
Lead Sponsor
Universidade Federal da Integração Latino-Americana do Brasil (UNILA).
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Individuals with PD clinically diagnosed according to the London Brain Bank criteria. Individuals who voluntarily agree with the procedures and information of the Free and Informed Consent Form. Have cognitive function that allows the understanding of past information by the researcher during the tests (Mini Mental State Examination). Do not present conditions that hinder or impede the movement of the upper limbs, such as: surgeries in the last 12 months; musculotendinosus injuries; fractures; use of prostheses or prostheses; other associated neurological or neurodegenerative conditions; etc. Individuals classified in phase 3 of the Hoeh and Yahr scale.

Exclusion criteria

Exclusion criteria: Withdrawal from participation in the research. Incomplete completion of the instruments. Individuals with treatment abandonment. Patients with symptoms of parkinsonism induced by exogenous intoxication, infectious, vascular, metabolic, genetic causes, other degenerative diseases or by drugs - such as dopaminergic receptor blockers, anticholinesterases, anticonvulsants, antiarrhythmics, reserpine, tetrabenazine, alfamethyldopa, lithium and fluoxetine. Patients who do not want to stop using monoamine oxidase (MAO) inhibitor drugs. Patients who do not interrupt the use of monoamine oxity (MAO) inhibitor drugs in 15 days before the start of the survey. MAO inhibitors are considered, among others, the following medications: Phenelzine; Iproniazid; Isocarboxazide; Harmalina; Nialamide; Pargyline; Selegiline; Toloxatone; Tranilcipromina. Patients who need to use the linezolid antibiotic, digoxin or phenytoin during the experiment. Diabetic patients or patients with other chronic diseases. Individuals with cardiac disorders or in the recovery phase of an acute myocardial infarction . Patients with reports of psychological disorders such as schizophrenia or bipolar disorder. Patients with renal or hepatic impairment. Pregnant or lactating patients. Patients who have changed the treatment of PD in the past 03 months.

Design outcomes

Primary

MeasureTime frame
As a null hypothesis, it will be assumed that the placebo and intervention groups will show equal results in measuring the motor effects of Parkinson's disease. Therefore, the intervention does not result in improvement of these symptoms. As an alternative hypothesis, it will be assumed that the placebo and intervention groups will present different results in measuring the motor effects of the disease Parkinson's disease, where the intervention group will present a lower result (score) compared to to the placebo group. Therefore, the intervention results in improvements in these symptoms.

Secondary

MeasureTime frame
Possible improvements in the patient's general condition.

Countries

Brazil

Contacts

Public ContactGilvan da Silva

Universidade Federal da Integração Latino-Americana do Brasil (UNILA).

gilvanaguiar@hotmail.com+554535292762

Outcome results

None listed

Source: REBEC (via WHO ICTRP)