Iron Supplementation on Treatment-Resistant Depressed Patients with Iron-Deficiency: A Randomized, Double-Blind, Placebo-Controlled Study

Iron Supplementation on Treatment-Resistant Depressed Patients with Iron-Deficiency: A Randomized, Double-Blind, Placebo-Controlled Study - Iron for Depression Study (ID Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032639

Enrollment

Registered

2018-05-18

Start date

2018-07-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Ferrochel Iron Bisglycinate as add-on therapy Placebo as add-on therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed as a depression (DSM-5) 2) [Criteria for Treatment-Resistant Depressed Patient] Treated with at least two anti-depressants for 4 weeks or more, respectively 3) Between 18 and 65 years old 4) Serum ferritin < 25 ng/ml 5) Total score of HDRS17 at baseline >= 14 6) Providing an informed consent

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactYukitsugu Imamura

Asahi General Hospital Department of Neuropsychiatry

y_imamura@hospital.asahi.chiba.jp+81-(0)479-63-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026