Assessment and pharmacotherapy for mental state in children considering biochemical examination.

JRCT ID: jRCTs031240317

Registered date:04/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with decreased serum ferritin levels
• Date of first enrollment: 04/09/2024
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Patients with decreased serum ferritin levels (<30 ng/mL) are given iron orally.

Outcome(s)

Primary Outcome

1. CGI-I: 4-9 weeks,12 weeks,24 weeks
2. CSHQ-J: before drug administration,12 weeks,24 weeks
3. Japanese version of Brief Fatigue Inventory: before drug administration,12 weeks,24 weeks

Secondary Outcome

1. Hematology (Hb, MCV): Baseline (0 week),12 wee ks (including 3 weeks before and after),24 weeks (including 3 weeks before and after)
2. Hematology (Fe, TIBC, ferritin): Baseline (0 week),12 weeks (including 3 weeks before and after ), 24 weeks (including 3 weeks before and after)
3. QCD:4-9 weeks,12 weeks,24 weeks
4. CGI-S: before drug administration, 4-9 weeks,12 weeks,24 weeks
5. POMS2: before drug administration,12 weeks,24 weeks

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 12age 11month 3weeks old
• Gender: Both

Include criteria

1. Patients visiting the outpatient psychiatry department of Tokai University Hospital or Aikou Hospital.
2. Age between 6 and 12 years old.
3. Ease of fatigue (moderate or severe on the Japanese version of the Brief Fatigue Inventory) or insomnia (42 or more points on the Japanese version of the Children's Sleep Habits Questionnaire (CSHQ-J))
4. Serum ferritin level less than 30 ng/mL.
5. Patients who have received a full explanation of their participation in this study and have obtained written consent from the research subjects and their guardians.

Exclude criteria

1. those taking psychotropic drugs (antipsychotics and antidepressants, anxiolytics, sleep medications, antiepileptic drugs) or steroids
2. have an active malignancy or known infectious, autoimmune, or inflammatory disease
3. Hb less than 12 g/dl
4. other patients who are deemed inappropriate by the physician in charge.

Related Information

• Primary Sponsor: Yuki Takahashi
• Source(s) of Monetary Support: The Institute of Seizon and Life Sciences