UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032639 |
|---|---|
| Receipt number | 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 11:38:31 |
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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
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
y_imamura@hospital.asahi.chiba.jp
Sponsor or person
Institute
Asahi General Hospital, Department of Neuropsychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037218
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
