Combination Therapy of Different Antidepressants With Dietary Supplements
NCT ID: NCT05931965
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2022-10-05
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Antidepressant
Participants receive either escitalopram 10-20mg, sertraline 50-100mg, fluoxetine 20-40mg, duloxetine 30-60mg, mirtazapine 15-30mg, venlafaxine 75-150mg, trazodone 50-100mg, amitriptyline 25-75mg, or clomipramine 25-75mg orally daily for 4 weeks.
No interventions assigned to this group
Antidepressant and L-methylfolate
Participants receive a combination of antidepressant and L-methylfolate 400µg twice daily orally for 4 weeks
L-methylfolate
Participants receive L-methylfolate 400µg orally twice daily for 4 weeks
Antidepressant and injectable mecobalamin
Participants receive a combination of antidepressant and mecobalamin 500µg intramuscularly stat on alternate days (6 total injections)
Vitamin B12
Participants receive mecobalamin 500µg intramuscularly stat on alternate days (6 total injections)
Antidepressant and Magnesium
Participants receive a combination of antidepressant and magnesium glycinate 400mg (Elemental: ≈120mg) twice daily orally for 4 weeks
magnesium
Participants receive magnesium glycinate 400mg twice daily orally for 4 weeks (elemental 120mg approx.)
Interventions
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L-methylfolate
Participants receive L-methylfolate 400µg orally twice daily for 4 weeks
Vitamin B12
Participants receive mecobalamin 500µg intramuscularly stat on alternate days (6 total injections)
magnesium
Participants receive magnesium glycinate 400mg twice daily orally for 4 weeks (elemental 120mg approx.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 12 and above
* Patients having low/marginal and low normal levels for arms 2 and 3 of respective supplements
* Patients having low/normal serum magnesium for arm 4
Exclusion Criteria
* History of kidney disease, myasthenia gravis
* Mentally handicapped or terminally ill patients
* Age less than 12 years
* Patients already taking multiple nutritional supplements
* Patients on polypharmacy with potential interactions with antidepressants and supplements in this study.
12 Years
ALL
No
Sponsors
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Riphah International University
OTHER
Responsible Party
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Principal Investigators
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Afifa Siddique, MBBS
Role: PRINCIPAL_INVESTIGATOR
IIMC-T, Riphah International University, Rawalpindi
Locations
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Pakistan Railway Hospital, IIMC-T, Riphah International University
Rawalpindi, Punjab Province, Pakistan
Countries
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References
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Serefko A, Szopa A, Poleszak E. Magnesium and depression. Magnes Res. 2016 Mar 1;29(3):112-119. doi: 10.1684/mrh.2016.0407.
Tarleton EK, Littenberg B, MacLean CD, Kennedy AG, Daley C. Role of magnesium supplementation in the treatment of depression: A randomized clinical trial. PLoS One. 2017 Jun 27;12(6):e0180067. doi: 10.1371/journal.pone.0180067. eCollection 2017.
Sun C, Wang R, Li Z, Zhang D. Dietary magnesium intake and risk of depression. J Affect Disord. 2019 Mar 1;246:627-632. doi: 10.1016/j.jad.2018.12.114. Epub 2018 Dec 27.
Noah L, Dye L, Bois De Fer B, Mazur A, Pickering G, Pouteau E. Effect of magnesium and vitamin B6 supplementation on mental health and quality of life in stressed healthy adults: Post-hoc analysis of a randomised controlled trial. Stress Health. 2021 Dec;37(5):1000-1009. doi: 10.1002/smi.3051. Epub 2021 May 6.
Chaban capital O, CyrillicS, Khaustova OO, Assonov DO, Sak LV. SAFETY AND EFFICACY OF THE COMPLEX DEPRILIUM(R) IN REDUCING SUBCLINICAL SYMPTOMS OF DEPRESSION IN PATIENTS WITH CHRONIC NON-COMMUNICABLE DISEASES: DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY. Wiad Lek. 2023;76(1):136-144. doi: 10.36740/WLek202301119.
Maruf AA, Poweleit EA, Brown LC, Strawn JR, Bousman CA. Systematic Review and Meta-Analysis of L-Methylfolate Augmentation in Depressive Disorders. Pharmacopsychiatry. 2022 May;55(3):139-147. doi: 10.1055/a-1681-2047. Epub 2021 Nov 18.
Hardin A, Baldwin-Sayre C. L-Methylfolate as a Monotherapy for Treatment-Resistant Depression: A Case Study. Integr Med (Encinitas). 2020 Aug;19(4):14-18.
Dartois LL, Stutzman DL, Morrow M. L-methylfolate Augmentation to Antidepressants for Adolescents with Treatment-Resistant Depression: A Case Series. J Child Adolesc Psychopharmacol. 2019 Jun;29(5):386-391. doi: 10.1089/cap.2019.0006. Epub 2019 May 6.
Markun S, Gravestock I, Jager L, Rosemann T, Pichierri G, Burgstaller JM. Effects of Vitamin B12 Supplementation on Cognitive Function, Depressive Symptoms, and Fatigue: A Systematic Review, Meta-Analysis, and Meta-Regression. Nutrients. 2021 Mar 12;13(3):923. doi: 10.3390/nu13030923.
Carter B, Zenasni Z, Moat SJ, Hudson PR, Russell IT, McCaddon A; FolATED group consists of the following authors. Plasma Methylmalonic Acid Concentration in Folic Acid-Supplemented Depressed Patients with Low or Marginal Vitamin B-12: A Randomized Trial. J Nutr. 2021 Dec 3;151(12):3738-3745. doi: 10.1093/jn/nxab280.
Siddique A, Khokhar MM, Waheed A, Naeem U, Aziz SA. Effect of combination therapy of methylfolate with antidepressants in patients with depressive disorder. BMC Pharmacol Toxicol. 2025 Jan 22;26(1):14. doi: 10.1186/s40360-025-00846-x.
Other Identifiers
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Riphah/IIMC/IRC/22/2069
Identifier Type: -
Identifier Source: org_study_id
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