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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013736
Receipt No. 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

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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
Email 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
Email nobumiyake@marianna-u.ac.jp

Sponsor
Institute Department of neuropsychiatry, St. Marianna University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016026

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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