Iron Supplementation on Treatment-Resistant Depressed Patients with Iron-Deficiency: A Randomized, Double-Blind, Placebo-Controlled Study
- Conditions
- Depression
- Registration Number
- JPRN-UMIN000032639
- Lead Sponsor
- Asahi General Hospital, Department of Neuropsychiatry
- Brief Summary
As the continuation of the research became difficult, the exam was discontinued. There was no participant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1) Iron-containing preparations (iron supplements, liver contrast agents for MRI, etc) within 4 weeks before providing informed consent 2) Electro-Convulsive Therapy within 4 weeks before providing informed consent 3) Unstable anti-depressant treatment for 4 weeks before providing informed consent 4) Suicide thought or attempt within six months before providing informed consent 5) With hallucinations, delusions 6) Serum hemoglobin < 10 g/dl 7) Hypersensitivity to iron-containing preparations 8) Hereditary hemochromatosis, paroxysmal nocturnal hemoglobinuria 9) Rheumatoid arthritis, thalassemia, hemolytic anemia, aplastic anemia 10) Serious infectious diseases, inflammatory diseases, cardiovascular diseases, liver diseases, renal diseases, cerebral organic diseases, blood diseases, endocrine diseases, spastic diseases, malignant tumors 11) Diagnosed as drug abuse, drug dependence, alcohol abuse, alcohol dependence 12) Pregnant women or under breast-feeding 13) HIV, HBV, HCV infection 14) The main psychotic state at the start of the test is excited or stupor 15) The doctor in charge judges he/she is ineligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in total score of the Hamilton Depression Rating Scale 17 items(HDRS17) between baseline and endpoint (12 weeks) cf. Primary outcomes changed from BDI-II to HDRS17 on 2018.7.20. The reason of this change is that HDRS17 may more suitable for the accessment of depression symptoms than BDI-II
- Secondary Outcome Measures
Name Time Method