UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050200 |
|---|---|
| Receipt number | R000057171 |
| Scientific Title | Association of serum ferritin levels with akathisia symptom in schizophrenia: a randomized controlled trial |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/05/17 09:49:12 |
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Basic information
Public title
Association of serum ferritin levels with akathisia symptom in schizophrenia: a randomized controlled trial
Acronym
Association of serum ferritin levels with akathisia symptom in schizophrenia: a randomized controlled trial
Scientific Title
Association of serum ferritin levels with akathisia symptom in schizophrenia: a randomized controlled trial
Scientific Title:Acronym
Association of serum ferritin levels with akathisia symptom in schizophrenia: a randomized controlled trial
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the association between akathisia symptoms and serum ferritin levels in schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A rating scale for drug-induced akathisia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 100 mg/day of sodium-ferrous-citrate
Interventions/Control_2
Placebo administration
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Schizophrenic patients with Barns' akathisia scale of 6 or more points and being treated with atypical antipsychotics.
Key exclusion criteria
1)Serum ferritin level of 50 or higher prior to intervention
2)Chlorpromazine equivalent of antipsychotic medication is 1000 mg/day or more
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Kurita hospital
Division name
Department of Psychiatry
Zip code
380-0921
Address
695 Kurita, Nagano City
TEL
026-226-1311
soundofdistiny@icloud.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Kurita hospital
Division name
Department of Psychiatry
Zip code
380-0921
Address
695 Kurita, Nagano City
TEL
026-226-1311
Homepage URL
soundofdistiny@icloud.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurita hospital
Address
695 Kurita, Nagano City
Tel
026-226-1311
soundofdistiny@icloud.com
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
| 2023 | Year | 03 | Month | 01 | 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
0
Results
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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057171
