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Oral Thiamine (Vitamin B1) for Depression in Children and Adolescents

NCT07793071 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Major Depressive Disorder (MDD)
  • Thiamine
  • Vitamin B1
  • Thiamine Diphosphate (TDP)
  • Pediatrics

Interventions

DRUG

thiamine hydrochloride 100 mg

Participants will receive 100 mg HCl oral thiamine capsules, which will be swallowed whole.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-01-01
Completion
2029-01-01
FDA Drug
Yes

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793071 on ClinicalTrials.gov