Oral Thiamine (Vitamin B1) for Depression in Children and Adolescents
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-17
SponsorMassachusetts General Hospital
About this trial
The goal of this study is to examine the effectiveness of thiamine in reducing depressive symptoms in children and adolescents. The investigators hypothesize that thiamine administration will alleviate depressive symptoms in children and adolescents and will have a favorable safety profile.
Participants will complete a baseline virtual visit with a study clinician and parent/guardian questionnaires to assess depression symptoms, medical history, current medications, and study eligibility.
Participants will complete fasting blood draws before and after the 4-week study period and, if eligible, receive study thiamine capsules by mail to take daily during the study.
Participants will attend weekly virtual visits for 4 weeks to monitor depression symptoms, safety, medication adherence, side effects, and any changes in medications or treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 8 to 17.5 years (inclusive) at the time of enrollment
Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Evidence of clinically significant symptoms of depression as indicated by a T score> 60 on the Children's Depression Inventory 2 (CDI-2) parent form at prescreening
Evidence of clinically significant symptoms of depression in the mild to moderate range as indicated by a score between 40 and 70 on the Children's Depression Rating Scale--Revised (CDRS-R) at screening
Disqualifiers
Recent history or active clinically significant manifestations of infectious, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, neurological, endocrinological or eyes, ears, nose, and throat disorders, or any other acute or chronic condition that, in the Investigator's opinion, would limit the participant's ability to complete or participate in this clinical study.
History of sensitivity to thiamine
Severe allergies or multiple adverse drug reactions.
History of nutritional deficiencies other than thiamine deficiency that could interfere with the study protocol or confound results.
Trial design
Design model
Single group
Treatments tested in this trial
thiamine hydrochloride 100 mg
DrugParticipants will receive 100 mg HCl oral thiamine capsules, which will be swallowed whole.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: ThiamineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
Change in depressive symptom severity from baseline to Week 4 as measured by the Children's Depression Rating Scale-Revised (CDRS-R). Lower scores indicate reduced depression severity and improvement in depressive symptoms over the course of thiamine treatment.
Time frame
28 daysSecondary outcomes
1
Number of Participants Demonstrating Clinical Improvement on the Clinical Global Impressions-Improvement (CGI-I) Scale
Number of participants demonstrating clinical improvement on the Clinical Global Impressions-Improvement (CGI-I) Scale at Week 4. The proportion of participants meeting the predefined improvement threshold will be reported along with the corresponding 95% confidence interval.
Time frame
28 daysOther outcomes
1
Concentration of End-of-Treatment Whole Blood Thiamine Diphosphate (TDP) and Depression Severity Measured by the Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Day 28
The association between whole blood thiamine diphosphate (TDP) concentration and depression severity at the end of treatment (Day 28) will be evaluated. Thiamine status will be assessed by measurement of TDP concentration in whole blood samples collected at Day 28. Depression severity will be assessed using the Children's Depression Rating Scale-Revised (CDRS-R) total score (range: 17 to 113; higher scores indicate greater depression severity). Regression models will be used to evaluate the relationship between Day 28 TDP concentration and Day 28 CDRS-R total score.
Time frame
28 days2
Change in Blood Concentrations of C-Reactive Protein (CRP), Tumor Necrosis Factor-Alpha (TNF-α), Interleukin-6 (IL-6), and Leptin From Baseline to Day 28
Blood concentrations of C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and leptin will be measured at baseline and Day 28. Change from baseline to Day 28 in each biomarker concentration will be assessed to characterize changes in inflammatory and metabolic biomarkers during thiamine supplementation. Changes over time will be evaluated using effect estimates and 95% confidence intervals.
Time frame
28 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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