Depressive DisorderNCT07198477
Sleep Disturbances and Their Association With Serum Magnesium Level in Patients With Major Depressive Disorder
An observational study of Depressive Disorder and Sleep Disturbances, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Sleep Disturbances
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
This cross-sectional study investigates the relationship between serum magnesium levels and the presence of sleep disturbances among patients with major depressive disorder (MDD).
Read the detailed description
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.
- Conditions
- Depressive Disorder, Sleep Disturbances
- Keywords
- sleep disturbances
- Medical subject headings
- Depressive Disorder, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the level of serum magnesium level
Serum magnesium concentration (mmol/L) measured by atomic absorption spectrophotometry for the patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start30 Aug 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alzahraa Aref Fouad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198477
- Sponsor's protocol ID
- Mg levels in major depression
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbances and Their Association With Serum Magnesium Level in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07198477
- Acronym / sponsor ID
- Mg levels in major depression
- Conditions
- Depressive Disorder, Sleep Disturbances
- Keywords
- sleep disturbances
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cross-sectional study investigates the relationship between serum magnesium levels and the presence of sleep disturbances among patients with major depressive disorder (MDD).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in the level of serum magnesium level
Time frame: Baseline
Serum magnesium concentration (mmol/L) measured by atomic absorption spectrophotometry for the patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Sleep Disturbances, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the level of serum magnesium level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.