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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031240317

Registered date:04/09/2024

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPatients with decreased serum ferritin levels
Date of first enrollment04/09/2024
Target sample size42
Countries of recruitment
Study typeInterventional
Intervention(s)Patients with decreased serum ferritin levels (<30 ng/mL) are given iron orally.

Outcome(s)

Primary OutcomeCGI-I. Evaluated at 12 weeks (including 3 weeks before and after) after administration.
Secondary Outcome1.Hematology (Hb, MCV) at baseline and 12 weeks (including 3 weeks before and after) and 24 weeks (including 3 weeks before and after)blood biochemical tests (Fe, TIBC, ferritin) 2.CGI-S, CSHQ-J, QCD, POMS2, Japanese Brief Fatigue Inventory, CSHQ-J 3.4-9 and 24 weeks (including 3 weeks before and after) CGI-I

Key inclusion & exclusion criteria

Age minimum>= 6age old
Age maximum<= 12age 11month 3weeks old
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Takahashi Yuki
Address 143 Shimokasuya Isehara City, Kanagawa, Japan Kanagawa Japan 259-1193
Telephone +81-463-93-1121
E-mail y-takahashi@tokai.ac.jp
Affiliation Tokai University Hospital
Scientific contact
Name Takahashi Yuki
Address 143 Shimokasuya Isehara City, Kanagawa, Japan Kanagawa Japan 259-1193
Telephone +81-463-93-1121
E-mail y-takahashi@tokai.ac.jp
Affiliation Tokai University Hospital