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

NCT07198477 | Not Yet Recruiting

• 1 other identifier: Mg levels in major depression
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depressive Disorder; Sleep Disturbances

Keywords

sleep disturbances

Outcome Measures

Primary Outcomes (1)

• change in the level of serum magnesium level

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

  Baseline

Study Arms (1)

Adult patients with major depressive disorder

The study sample will include 90 psychiatric patients recruited from the outpatient and inpatient clinics of Assiut University Hospital, representing males and females aged 18-60 years. All participants will have a confirmed diagnosis of major depressive disorder based on clinical criteria and will be evaluated using standardized psychiatric assessment tools.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study sample will include 90 psychiatric patients recruited from the outpatient and inpatient clinics of Assiut University Hospital, representing males and females aged 18-60 years. All participants will have a confirmed diagnosis of major depressive disorder based on clinical criteria and will be evaluated using standardized psychiatric assessment tools. Exclusion criteria were designed to rule out metabolic comorbidities, chronic renal conditions, and medication effects that may confound serum magnesium interpretation. Patients unable to complete questionnaires due to cognitive or language difficulties, as well as those with other psychiatric disorders, will also be excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Depressive Disorder; Parasomnias

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the Neuropsychiatry department

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: September 30, 2025
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09