UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Iron Supplementation on Treatment-Resistant Depressed Patients with Iron-Deficiency: A Randomized, Double-Blind, Placebo-Controlled Study
Title of the study (Brief title)	Iron for Depression Study (ID Study)
Region	Japan

Condition
Condition	Depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of iron supplementation in treatment-resistant depressed patients with iron-deficiency
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ferrochel Iron Bisglycinate as add-on therapy
Interventions/Control_2	Placebo as add-on therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	60

Research contact person
Name of lead principal investigator	Yukitsugu Imamura
Organization	Asahi General Hospital
Division name	Department of Neuropsychiatry
Address	i-1326, Asahi, Chiba, Japan
TEL	+81-(0)479-63-8111
Email	y_imamura@hospital.asahi.chiba.jp

Public contact
Name of contact person	Yukitsugu Imamura
Organization	Asahi General Hospital
Division name	Department of Neuropsychiatry
Address	i-1326, Asahi, Chiba, Japan
TEL	+81-(0)479-63-8111
Homepage URL
Email	y_imamura@hospital.asahi.chiba.jp

Sponsor
Institute	Asahi General Hospital, Department of Neuropsychiatry
Institute
Department

Funding Source
Organization	Asahi General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 04 Month 25 Day
Anticipated trial start date	2018 Year 07 Month 20 Day
Last follow-up date	2018 Year 11 Month 26 Day
Date of closure to data entry	2018 Year 11 Month 26 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	As the continuation of the research became difficult, the exam was discontinued. There was no participant.
Other related information

Management information
Registered date	2018 Year 05 Month 18 Day
Last modified on	2018 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037218