Melatonin Replacement Therapy in Pinealectomized Patients

Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03885258

Enrollment

Registered

2019-03-21

Start date

2017-05-02

Completion date

2019-02-28

Last updated

2019-03-21

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

Conditions

Pineal Tumor

Keywords

melatonin, pinealectomy, Cardiac Autonomic System, heart rate variability

Brief summary

This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients.

Detailed description

This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients. The study consists of a screening period, followed by a 3-month melatonin treatment period, and a 6-month washout follow-up period. Adverse events were monitored with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.

Interventions

DRUGMelatonin Replacement Therapy

Melatonin (Aché Pharmaceutics, Brazil), 3 mg, administered in the evening, 30 minutes before the usual bedtime, every day for 3 months. After discontinuation of melatonin therapy, patients are followed up for 6 months to assess safety parameters and cardiac autonomic activity.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

This is an open-label, single-arm, single-center, proof-of-concept study

Eligibility

Healthy volunteers

Inclusion criteria

* patients with pinealectomy and all of the following criteria were considered for admission to the clinical trial: * children, adolescents and young adults 0 months to 25 years of age; * signed written informed consent (patient or his/her parents/legal guardian); * willing and able to complete the clinical trial procedures, as described in the protocol * no recurring tumor after pinealectomy and subsequent chemotherapy * absence of circulating melatonin evaluated by salivary melatonin Elisa assay

Exclusion criteria

* patients with cardiac arrhythmias * potentially non-compliant subjects judged by the investigator to be unsuitable for the study

Design outcomes

Primary

Measure	Time frame	Description
cardiac autonomic function - heart rate variability	9 months	The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026