Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07198477

Sleep Disturbances and Their Association With Serum Magnesium Level in Patients With Major Depressive Disorder

This cross-sectional study investigates the relationship between serum magnesium levels and the presence of sleep disturbances among patients with major depressive disorder (MDD).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Major depressive disorder is a highly prevalent psychiatric condition often accompanied by disabling sleep disturbances, including insomnia and hypersomnia. Evidence suggests that magnesium, a vital trace element involved in neurotransmission, stress response, and circadian regulation, may play a crucial role in both mood and sleep. Low serum magnesium levels have been linked to increased depressive symptom severity and disturbed sleep quality. This study seeks to explore whether hypomagnesemia can serve as a biological contributor to sleep dysfunction in MDD. By employing the Beck Depression Inventory-II (BDI-II) and the Pittsburgh Sleep Quality Index (PSQI), as well as laboratory measurement of serum magnesium levels, the study aims to determine whether lower magnesium is significantly associated with greater depressive burden and poor sleep outcomes. The findings may help validate magnesium as a biomarker for early screening and risk stratification in psychiatric care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of major depressive disorder

age 18 years and older

Ability to complete questionnaires (BDI-II and PSQI; validated Arabic versions)

Willing to participate and provide informed consent

Exclusion criteria

  • hronic renal failure or metabolic disorders affecting magnesium balance

Current use of medications known to significantly interfere with serum magnesium (e.g., long-term diuretics, proton pump inhibitors) unless stable and documented

Presence of other comorbid psychiatric disorders

Cognitive impairment or language difficulties preventing questionnaire completion

Treatment and study plan

Primary outcomes

  1. change in the level of serum magnesium level

    Time frame: Baseline

    Serum magnesium concentration (mmol/L) measured by atomic absorption spectrophotometry for the patients.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.