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

Sponsor
Massachusetts General Hospital
Study ID
NCT07793071
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • thiamine hydrochloride 100 mg — DRUG
    Participants will receive 100 mg HCl oral thiamine capsules, which will be swallowed whole.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Thiamine
    Participants will receive 100 mg HCl oral thiamine capsules, which will be swallowed whole.

Primary Outcome Measure

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score [ Time Frame: 28 days ]

Central Contacts

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