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Effect of Melatonin on Memory in Multiple Sclerosis Patients

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251006067522N1
Enrollment
50
Registered
2025-10-29
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Multiple Sclerosis (Relapsing-Remitting Type). Multiple sclerosis

Interventions

Intervention group: Melatonin administration: Patients receive 5 mg of melatonin daily, one hour before sleep, for 12 weeks..

Sponsors

Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of MS based on McDonald criteria and confirmed by a specialist physician. Age between 18 and 60 years. Diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS). Suffering from short-term memory disorders detectable by pre-test assessment.

Exclusion criteria

Exclusion criteria: Age less than 18 years or more than 60 years. Lack of written patient consent to participate in the study. Diagnosis of MS types other than Relapsing-Remitting MS (RRMS). Use of other medications that may affect memory or sleep. History of allergy or sensitivity to melatonin. Presence of other chronic conditions such as uncontrolled diabetes or kidney failure. Alcohol or drug use in the past 6 months. Pregnancy or breastfeeding

Design outcomes

Primary

MeasureTime frame
Short-term visual memory Description: Short-term visual memory is measured using the Colour Wheel Test. This variable refers to the patients' ability to recall and reproduce colours within a short time frame (a few seconds to a few minutes), with evaluation criteria including error rate, response time, and confidence in colour selection. Timepoint: Measurement of outcome variables will be conducted at two time points: initially, before the intervention (pre-test) and then 12 weeks after the start of melatonin use (post-test). Method of measurement: Short-term visual memory: Measured using the Colour Wheel Test, which involves selecting colours on a simulated display screen, with criteria including error rate, response time, and confidence in selection.;Potential side effects of melatonin are recorded through patient reports and clinical examinations by healthcare staff. This variable includes any physical or psychological symptoms reported by patients during the intervention period. Timepoint: Measurement of outcome variables will be conducted at two time points: initially, before the intervention (pre-test) and then 12 weeks after the start of melatonin use (post-test). Method of measurement: Recorded through patient verbal reports and clinical examinations by healthcare staff.;Changes in quality of life are assessed using standard questionnaires (such as health-related quality of life questionnaires). This variable reflects improvements or reductions in general well-being, daily functioning, and patient satisfaction with life. Timepoint: Measurement of outcome variables will be conducted at two time points: initially before the intervention (pre-test) and then 12 weeks after the start of melatonin use (post-test). Method of measurement: Changes in quality of life: Assessed using standard health-related quality of life questionnaires (e.g., SF-36).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKavosh Ansari Dezfoli

Qazvin University of Medical Sciences

k.ansaridezfoli@qums.ac.ir+98 937 538 6185

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026