- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458022
MAGNESIUM & SSRI VS SSRI ALONE AMONG PATIENTS OF MAJOR DEPRESSIVE DISORDER
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Punjab Province
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Multan, Punjab Province, Pakistan, 60000
- Combined Military Hospital (CMH)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
All patients of above 18 years diagnosed with DSM who had MDD and receiving SSRI alone and SSRI plus magnesium.
Exclusion Criteria:
Individuals who recently underwent treatment with electroconvulsive therapy, have a history of epilepsy or other severe neurological problems, have experienced a head injury, are cognitively impaired, and have comorbid conditions such as liver, renal, cardiovascular, neurological, or endocrine, or respiratory problems, or are pregnant or nursing mothers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional Arm
Patients in this group will be treated with SSRI and magnesium therapy for four weeks
|
Impact of combination of SSRI and Magnesium in Major Depressive Disorder
|
|
Placebo Comparator: Placebo
Patients in this group will be treated with SSRI as a placebo in interventional treatment.
|
Only SSRI will be given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in severity of depressive symptoms
Time Frame: Four Weeks
|
Change in severity of depressive symptoms, measured by the difference in mean scores on the Beck Depression Inventory-II (BDI-II) from baseline to 4 weeks post-intervention
|
Four Weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Atif Najum, MBBS, FCPS, CMH Multan
Publications and helpful links
Helpful Links
- Older adults with hypertension have an increased risk of depression compared to their younger counterparts
- Management of treatment-resistant depression: challenges and strategies. Neuropsychiatric disease and treatment.
- Dietary magnesium intake and risk of depression. Journal of affective disorders.
- Possible relation between consumption of different food groups and depression.
- The way to a human's brain goes through their stomach: dietary factors in major depressive disorder
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERC No. 31/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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