MDDPhase 2NCT04880460
Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients
A Phase 2 study testing Magnesium Glycinate tablet 200mg in people with MDD, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
A randomized, double-blind, placebo-controlled trial was conducted to assess the effect of magnesium glycinate on symptoms of moderate to severe depression in 90 patients. Patients were assessed at baseline, end of the 4 weeks, and end of the 8 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MDD
- What is being tested?
- Magnesium Glycinate tablet 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBangladesh
- Study dates
- 18 Mar 2021to 21 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Newly diagnosed 18 years or older MDD patients of both gender according to DSM-5 at the Outpatient Department of Psychiatry, BSMMU
- Moderate to severe MDD according to DASS-21 (scores of 14-27)
- Patients prescribed only SSRIs
Who cannot join
- Patients having any other psychiatric disease, kidney disease, or gastrointestinal disease
- Taking dietary supplements in the last two months
- Taking fluoroquinolones, aminoglycosides, tetracyclines, calcium channel blockers, bisphosphonates, and skeletal muscle relaxants
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients: A Randomized, Double-Blind, Placebo-Controlled Trial
A randomized, double-blind, placebo-controlled trial was conducted to assess the effect of magnesium glycinate on symptoms of moderate to severe depression in 90 patients. Patients were assessed at baseline, end of the 4 weeks, and end of the 8 weeks of treatment. Patients were randomized to receive either 200 mg elemental magnesium or 200 mg placebo tablet twice daily for 8 weeks. The primary outcome measure was depression severity score assessment using Depression Anxiety Stress Scale 21 items Bangla Version (DASS-21 BV) and the secondary outcome measure was serum magnesium level estimation and side effects assessment using a preformed checklist.
Read the detailed description
Major depressive disorder (MDD), is a mood disorder affecting 300 million people worldwide with a prevalence of 6.7% in Bangladesh. Depression is the main contributor to suicidal deaths and is globally ranked as the single largest contributor to non-fatal health loss. Various psychological, genetic, environmental, and biochemical factors are presumed to be involved in the causation of MDD. About 30% to 50% of patients do not respond to initial antidepressant medication, and 15% of them continue to suffer from symptoms despite the completion of multiple antidepressants and more aggressive treatment regimens, in addition to facing untoward adverse drug reactions with increasing dose. Recent trials attempted to assess the effect of magnesium in reducing depressive symptoms in MDD patients. This study evaluates whether there was any role of magnesium in reducing depressive symptoms between those who did and did not receive magnesium in 8 weeks period. Patients attending the Outpatient Department of Psychiatry, BSMMU, and diagnosed with MDD were evaluated using the DASS-21 BV for assessment of severity. Those patients who were experiencing moderate to severe symptoms (scores of 14-27) were enrolled according to inclusion and exclusion criteria. Total enrolled 90 MDD patients who have received either 200 mg elemental magnesium twice daily in the form of magnesium glycinate tablet or 200 mg placebo tablet twice daily for 8 weeks. A baseline depression severity score assessment was done using DASS-21 items and again repeated at the end of the 4 weeks and 8 weeks of treatment. Initially, baseline serum magnesium level (mg/dL) was measured and repeated again at the end of the 8 weeks of treatment. DASS-21 is a validated set of three self-report scales to measure the state of depression, anxiety, and stress, where each of the three scales contains 7 items, and each item is rated from 0 to 3. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest, anhedonia, and inertia.
- Conditions
- MDD
- Being tested
- Magnesium Glycinate tablet 200mg, Placebo tablet 200mg
- Keywords
- MDD, Magnesium, DASS-21, Serum magnesium level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Glycinate tablet 200mgDietary supplement
Magnesium glycinate tablet 200mg twice daily orally for 8 weeks along with SSRIs
Placebo tablet 200mgDietary supplement
Placebo tablet 200mg twice daily orally for 8 weeks along with SSRIs
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | 45 MDD patients were included in this arm who were received SSRIs and Magnesium tablets Receives: Dietary Supplement: Magnesium Glycinate tablet 200mg |
| Control | Placebo comparator | 45 MDD patients were included in this arm who were received SSRIs and placebo tablets Receives: Dietary Supplement: Placebo tablet 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity score assessment
Assessed the severity score of depressive symptoms using DASS-21 at baseline, end of the 4 weeks, and end of the 8 weeks treatment.
Compared the score between before and after treatment. Compared the score between two arms. DASS21 score range from 0-28+ with the following scores: 0-9 Normal, 10-13 Mild, 14-20 Moderate, 21-27 Severe, 28+ Extremely severe.
Measured: 8 weeks
Secondary outcomes (2)
Biochemical assessment
Serum magnesium level (mg/dL) was measured at baseline and end of the 8 weeks treatment.
Compared the serum magnesium level (mg/dL) between before and after treatment. Compare the serum magnesium level (mg/dL) between two arms.
Measured: 8 weeks
Side effects assessment
Participants were asked about the side effects using a preformed checklist. And compare the effects between two arms.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start18 Mar 2021
- Primary completion21 Nov 2021
- Study completion21 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sarmin Sultana, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Prof. Md. Sayedur Rahman, MBBS, MPhil, FCPS, Study chair, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880460
- Sponsor's protocol ID
- BSMMU/2021/257
- Status last verified
- Nov 2021
- First submitted
- 4 May 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04880460
- Acronym / sponsor ID
- BSMMU/2021/257
- Conditions
- MDD
- Keywords
- MDD, Magnesium, DASS-21, Serum magnesium level
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 21 Nov 2021 (actual)
- Study completion
- 21 Nov 2021 (actual)
- First posted
- 10 May 2021 (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.
A randomized, double-blind, placebo-controlled trial was conducted to assess the effect of magnesium glycinate on symptoms of moderate to severe depression in 90 patients. Patients were assessed at baseline, end of the 4 weeks, and end of the 8 weeks of treatment. Patients were randomized to receive either 200 mg elemental magnesium or 200 mg placebo tablet twice daily for 8 weeks. The primary outcome measure was depression severity score assessment using Depression Anxiety Stress Scale 21 items Bangla Version (DASS-21 BV) and the secondary outcome measure was serum magnesium level estimation and side effects assessment using a preformed checklist.
Detailed description
Major depressive disorder (MDD), is a mood disorder affecting 300 million people worldwide with a prevalence of 6.7% in Bangladesh. Depression is the main contributor to suicidal deaths and is globally ranked as the single largest contributor to non-fatal health loss. Various psychological, genetic, environmental, and biochemical factors are presumed to be involved in the causation of MDD. About 30% to 50% of patients do not respond to initial antidepressant medication, and 15% of them continue to suffer from symptoms despite the completion of multiple antidepressants and more aggressive treatment regimens, in addition to facing untoward adverse drug reactions with increasing dose. Recent trials attempted to assess the effect of magnesium in reducing depressive symptoms in MDD patients. This study evaluates whether there was any role of magnesium in reducing depressive symptoms between those who did and did not receive magnesium in 8 weeks period. Patients attending the Outpatient Department of Psychiatry, BSMMU, and diagnosed with MDD were evaluated using the DASS-21 BV for assessment of severity. Those patients who were experiencing moderate to severe symptoms (scores of 14-27) were enrolled according to inclusion and exclusion criteria. Total enrolled 90 MDD patients who have received either 200 mg elemental magnesium twice daily in the form of magnesium glycinate tablet or 200 mg placebo tablet twice daily for 8 weeks. A baseline depression severity score assessment was done using DASS-21 items and again repeated at the end of the 4 weeks and 8 weeks of treatment. Initially, baseline serum magnesium level (mg/dL) was measured and repeated again at the end of the 8 weeks of treatment. DASS-21 is a validated set of three self-report scales to measure the state of depression, anxiety, and stress, where each of the three scales contains 7 items, and each item is rated from 0 to 3. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest, anhedonia, and inertia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Dietary Supplement: Magnesium Glycinate tablet 200mg45 MDD patients were included in this arm who were received SSRIs and Magnesium tablets |
| Control | Placebo comparator | Dietary Supplement: Placebo tablet 200mg45 MDD patients were included in this arm who were received SSRIs and placebo tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed 18 years or older MDD patients of both gender according to DSM-5 at the Outpatient Department of Psychiatry, BSMMU
- Moderate to severe MDD according to DASS-21 (scores of 14-27)
- Patients prescribed only SSRIs
Key exclusion criteria (4 listed)
- Patients having any other psychiatric disease, kidney disease, or gastrointestinal disease
- Taking dietary supplements in the last two months
- Taking fluoroquinolones, aminoglycosides, tetracyclines, calcium channel blockers, bisphosphonates, and skeletal muscle relaxants
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Glycinate tablet 200mgMagnesium glycinate tablet 200mg twice daily orally for 8 weeks along with SSRIs | Dietary supplement | Experimental |
| Placebo tablet 200mgPlacebo tablet 200mg twice daily orally for 8 weeks along with SSRIs | Dietary supplement | Control |
Primary outcome
Depression severity score assessment
Time frame: 8 weeks
Assessed the severity score of depressive symptoms using DASS-21 at baseline, end of the 4 weeks, and end of the 8 weeks treatment. Compared the score between before and after treatment. Compared the score between two arms. DASS21 score range from 0-28+ with the following scores: 0-9 Normal, 10-13 Mild, 14-20 Moderate, 21-27 Severe, 28+ Extremely severe.
2 secondary outcomes
Biochemical assessment
Time frame: 8 weeks
Side effects assessment
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Prof. Md. Sayedur Rahman, MBBS, MPhil, FCPS study chair
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium Glycinate tablet 200mg in people with MDD, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 3 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: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression severity score assessment (time frame: 8 weeks). 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 21 Mar 2022.