UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of N-acetylcysteine in subjects with at-risk mental state
Title of the study (Brief title)	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	Nobumi Miyake
Organization	St. Marianna University School of Medicine
Division name	Department of neuropsychiatry
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	Nobumi Miyake
Organization	St. Marianna University School of Medicine
Division name	Department of neuropsychiatry
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 07 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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