Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04880460|
Recruitment Status : Completed
First Posted : May 10, 2021
Last Update Posted : March 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|MDD||Dietary Supplement: Magnesium Glycinate tablet 200mg Dietary Supplement: Placebo tablet 200mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Investigator)|
|Masking Description:||A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. The type of masking was double-blind masking.|
|Official Title:||Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients: A Randomized, Double-Blind, Placebo-Controlled Trial|
|Actual Study Start Date :||March 18, 2021|
|Actual Primary Completion Date :||November 21, 2021|
|Actual Study Completion Date :||November 21, 2021|
Active Comparator: Experimental
45 MDD patients were included in this arm who were received SSRIs and Magnesium tablets
Dietary Supplement: Magnesium Glycinate tablet 200mg
Magnesium glycinate tablet 200mg twice daily orally for 8 weeks along with SSRIs
Placebo Comparator: Control
45 MDD patients were included in this arm who were received SSRIs and placebo tablets
Dietary Supplement: Placebo tablet 200mg
Placebo tablet 200mg twice daily orally for 8 weeks along with SSRIs
- 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.
- Biochemical assessment [ Time Frame: 8 weeks ]
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.
- Side effects assessment [ Time Frame: 8 weeks ]Participants were asked about the side effects using a preformed checklist. And compare the effects between two arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04880460
|Basic Science and Paraclinical Science of BSMMU|
|Study Chair:||Prof. Md. Sayedur Rahman, MBBS, MPhil, FCPS||Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh|