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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032639
Receipt No. R000037218
Scientific Title Iron Supplementation on Treatment-Resistant Depressed Patients with Iron-Deficiency: A Randomized, Double-Blind, Placebo-Controlled Study
Date of disclosure of the study information 2018/05/18
Last modified on 2018/11/26

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Basic information
Public title Iron Supplementation on Treatment-Resistant Depressed Patients with Iron-Deficiency: A Randomized, Double-Blind, Placebo-Controlled Study
Acronym Iron for Depression Study (ID Study)
Scientific Title Iron Supplementation on Treatment-Resistant Depressed Patients with Iron-Deficiency: A Randomized, Double-Blind, Placebo-Controlled Study
Scientific Title:Acronym 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
1st name
Middle name
Last name Yukitsugu Imamura
Organization Asahi General Hospital
Division name Department of Neuropsychiatry
Zip code
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
1st name
Middle name
Last name Yukitsugu Imamura
Organization Asahi General Hospital
Division name Department of Neuropsychiatry
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
As the continuation of the research became difficult, the exam was discontinued. There was no participant.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 04 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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