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 |
Effects of N-acetylcysteine in subjects with at-risk mental state
Effects of N-acetylcysteine in subjects with at-risk mental state
Effects of N-acetylcysteine in subjects with at-risk mental state
Effects of N-acetylcysteine in subjects with at-risk mental state
Japan |
At-risk mental state
Psychiatry |
Others
NO
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.
Efficacy
Exploratory
Pragmatic
Not applicable
Changes in the Scale of Prodromal Symptoms (SOPS)
Clinical evaluations: baseline, 12- and 24-weeks
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is considered as a block.
NO
Pseudo-randomization
2
Treatment
Medicine | Food |
Control group with subthreshold psychosis are given normal treatment (supportive psychotherapy) including minimum use of the psychotropic drugs.
Subjects with subthreshold psychosis are given normal treatment with NAC (2000mg/day) as supplementation for 12 weeks.
16 | years-old | <= |
40 | years-old | > |
Male and Female
Individuals meeting criteria of prodromal syndromes based on the structural interview for prodromal symptoms are recruited from St. Marianna University School of Medicine Hospital.
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.
60
1st name | |
Middle name | |
Last name | Nobumi Miyake |
St. Marianna University School of Medicine
Department of neuropsychiatry
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
044-977-8111
nobumiyake@marianna-u.ac.jp
1st name | |
Middle name | |
Last name | Nobumi Miyake |
St. Marianna University School of Medicine
Department of neuropsychiatry
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
044-977-8111
nobumiyake@marianna-u.ac.jp
Department of neuropsychiatry, St. Marianna University School of Medicine
JSPS Grant-in-Aid for Young Scientists (B) 24791239
Japanese Governmental office
Japan
NO
聖マリアンナ医科大学病院(神奈川県)
2014 | Year | 04 | Month | 16 | Day |
Unpublished
Terminated
2012 | Year | 07 | Month | 09 | Day |
2012 | Year | 10 | Month | 23 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2014 | Year | 04 | Month | 16 | Day |
2017 | Year | 08 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016026