Investigating the Effect of Melatonin on Memory in Multiple Sclerosis Patients: A Clinical Trial

The primary objective of this study is to investigate the effect of melatonin on short-term visual memory in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) at Buali Hospital in Qazvin in 2025.

This study is designed as a Quasi-Experimental trial with a single-group pre-test and post-test design. Only one group of patients receiving melatonin will be evaluated, and visual working memory data will be collected before and after the intervention period.

The study will be conducted at Buali Hospital in Qazvin under the supervision of the Research Deputy of Qazvin University of Medical Sciences.

Patients with a definitive diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) based on McDonald criteria and confirmed by a specialist physician, aged 18 to 60 years, suffering from short-term memory disorders detectable by pre-test assessment, no use of memory- or sleep-affecting medications in the past month, willing to provide written informed consent, no history of allergy to melatonin, not pregnant or breastfeeding, and with a stable disease condition with no relapse in the last 30 days and be excluded if the inclusion criteria doesnt met.

This study includes only one intervention group, consisting of 50 randomly selected patients with Relapsing-Remitting MS. These patients will receive 5 mg of melatonin daily, one hour before sleep, for 12 weeks. No control or placebo group is included in this design.

Short-term visual memory, measured using the Color Wheel Test. Potential side effects of melatonin, recorded through patient reports and clinical examination. Changes in quality of life, assessed using standard questionnaires.

The data within the document includes aggregated study design information, inclusion/exclusion criteria, primary outcome variables, and initial IRCT registration details. Due to ethical considerations and privacy concerns, individual participant data (e.g., memory test results or personal details) cannot be fully shared; only de-identified data related to primary outcomes (e.g., Colour Wheel Test results) can be provided after receiving approval from the Qazvin University of Medical Sciences Ethics Committee and complying with institutional policies. The document also contains a CRS system link and preliminary IRCT registration information, indicating the clinical trial registration process.

The access period for the data/document will begin 6 months after the publication of the study results, anticipated to be around mid-April 2026, and will remain available for 5 years thereafter.

Access to the data or document is allowed for researchers affiliated with accredited academic or scientific institutions. These individuals must submit a formal request with identification documents and a description of their research aims, while following ethical guidelines and privacy laws.

The data or document may only be used for academic research purposes, including statistical analysis, replication studies, and scientific investigations related to the effect of melatonin on memory in patients with multiple sclerosis. Usage conditions include obtaining ethical approval from the Qazvin University of Medical Sciences Ethics Committee, signing a confidentiality and data use agreement, and ensuring that no participant can be re-identified. Applicants must submit a written request outlining their research objectives, analysis.

Applicants seeking access to the data or documents should first contact the Principal Investigator, Dr. Hossein Mozhdehipanah, via email (hmozhdehipanah@qums.ac.ir) or phone (09123040087). If there is no response, they are advised to reach out to the Research Deputy of Qazvin University of Medical Sciences through the website or by phone (028-33336001). Additionally, the IRCT support system can be contacted via email (irct@iums.ac.ir) if necessary. Priority is given to official email communication, and a written request with the necessary documentation must be submitted.

The process for requesting data/documents is as follows: The applicant must submit a written request, including research objectives, analysis methods, and identification documents, to the Principal Investigator’s email (hmozhdehipanah@qums.ac.ir). The request will be reviewed by the Principal Investigator and referred to the Qazvin University of Medical Sciences Ethics Committee for ethical approval (approximate duration: 1-2 weeks). Upon ethical approval, the applicant must sign a confidentiality and data use agreement. After completing the agreement, the de-identified data will be provided securely (e.g., encrypted file) via email or the university’s secure platform. In case of issues, the applicant may contact the Research Deputy or IRCT support (irct@iums.ac.ir). The entire process typically takes 2-3 weeks, contingent on complete documentation and compliance with regulations.