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Trazodone for movement symptoms

This study compares trazodone with a placebo to investigate its effects on Parkinson's movement difficulties.

Testing a treatment or activity · Study reference: RBR-4b32m3

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported date)
2020-07-10

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age range not listed · Ask the team who can join

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: -

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: 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.
Full study name & original research details

Official study title

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.

Short title used by the registry

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

Original description

Intervention: 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 trazodone chloridate per day for 1 (one) month. The dose will be increased in the second month to two tablets of 50 mg / day, every 12 hours. In the third month, the dose will be increased in the form of 3 tablets 50mg / day, every 8 hours. In the fifth month the dose will be reduced to two tablets of 50 mg / day, every 12 hours. In the sixth month the dose will be reduced to 50mg of trazodone chloridate daily as a daily tablet. The placebo group will do the same treatment, however, using a placebo.;Drug Primary outcome: 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 outcome: Possible improvements in the patient's general condition.

Conditions reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
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 trazodone chloridate per day for 1 (one) month. The dose will be increased in the second month to two tablets of 50 mg / day, every 12 hours. In the third month, the dose will be increased in the form of 3 tablets 50mg / day, every 8 hours. In the fifth month the dose will be reduced to two tablets of 50 mg / day, every 12 hours. In the sixth month the dose will be reduced to 50mg of trazodone chloridate daily as a daily tablet. The placebo group will do the same treatment, however, using a placebo.;Drug
Phases
N/A
Sponsor
Universidade Federal da Integração Latino-Americana do Brasil (UNILA).
Start date reported by registry
2020-07-10 (reported)

Registry updated: Not reported · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Gilvan da Silva · +554535292762 · gilvanaguiar@hotmail.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Facility not reported

Brazil

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.