UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013736 |
|---|---|
| Receipt number | R000016026 |
| Scientific Title | Effects of N-acetylcysteine in subjects with at-risk mental state |
| Date of disclosure of the study information | 2014/04/16 |
| Last modified on | 2017/08/21 15:46:50 |
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Basic information
Public title
Effects of N-acetylcysteine in subjects with at-risk mental state
Acronym
Effects of N-acetylcysteine in subjects with at-risk mental state
Scientific Title
Effects of N-acetylcysteine in subjects with at-risk mental state
Scientific Title:Acronym
Effects of N-acetylcysteine in subjects with at-risk mental state
Region
| Japan |
Condition
Condition
At-risk mental state
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safer preventive intervention of psychosis in subjects with at-risk mental state (ARMS) is warranted. Given that N-acetylcysteine (NAC), a glutathione precursor, has neuroprotective effects, its preventive use in psychosis merits investigation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the Scale of Prodromal Symptoms (SOPS)
Clinical evaluations: baseline, 12- and 24-weeks
Key secondary outcomes
Magnetic resonance spectroscopy, Brief Assessment of Cognition in Schizophrenia-Japanese language version (BACS-J), Schizophrenia Cognition Rating Scale (SCoRS), UCSD Performance-based Skills Assessment-Brief (UPSA-B), Schizophrenia Quality of Life Scale-Japanese version (SQLS-J), Drug-Induced Extrapyramidal Symptoms Scale(DIEPSS), laboratory tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Control group with subthreshold psychosis are given normal treatment (supportive psychotherapy) including minimum use of the psychotropic drugs.
Interventions/Control_2
Subjects with subthreshold psychosis are given normal treatment with NAC (2000mg/day) as supplementation for 12 weeks.
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
| 16 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals meeting criteria of prodromal syndromes based on the structural interview for prodromal symptoms are recruited from St. Marianna University School of Medicine Hospital.
Key exclusion criteria
i) comorbid central nervous system disorder
ii) meeting the DSM-IV-TR criteria for current and/or past alcohol or other substance dependence or abuse
iii) meeting the DSM-IV-TR criteria for mental retardation
iv) taking tricyclic antidepressants
v) treatment with electroconvulsive therapy within the 12 weeks preceding the study
vi) treatment with lithium, valproic acid, carbamazepine
vii) patients who were not voluntarily hospitalized
viii) active expression of suicidal ideation
ix) pregnancy or breast feeding
x) inability to understand the study protocol or being judged as uncooperative by the rater.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobumi Miyake |
Organization
St. Marianna University School of Medicine
Division name
Department of neuropsychiatry
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
nobumiyake@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobumi Miyake |
Organization
St. Marianna University School of Medicine
Division name
Department of neuropsychiatry
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
Homepage URL
nobumiyake@marianna-u.ac.jp
Sponsor or person
Institute
Department of neuropsychiatry, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS Grant-in-Aid for Young Scientists (B) 24791239
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 16 | 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
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
| 2012 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016026
