JRCT ID: jRCTs031240317
Registered date:04/09/2024
Assessment and pharmacotherapy for mental state in children considering biochemical examination.
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Patients with decreased serum ferritin levels |
Date of first enrollment | 04/09/2024 |
Target sample size | 42 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Patients with decreased serum ferritin levels (<30 ng/mL) are given iron orally. |
Outcome(s)
Primary Outcome | CGI-I. Evaluated at 12 weeks (including 3 weeks before and after) after administration. |
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Secondary Outcome | 1.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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | The Institute of Seizon and Life Sciences |
Secondary ID(s) |
Contact
Public contact | |
Name | Takahashi Yuki |
Address | 143 Shimokasuya Isehara City, Kanagawa, Japan Kanagawa Japan 259-1193 |
Telephone | +81-463-93-1121 |
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 |
y-takahashi@tokai.ac.jp | |
Affiliation | Tokai University Hospital |