Protocol summary

Summary
N-acetylcysteine (NAC) had been administered for treatment of different psychiatric disorders. NAC increases GSH level. It is supposed that NAC may decrease the symptoms of autism. 40 children and adolescents with autism are allocated to one of the two groups. One group will receive NAC and the other group will receive placebo. Both group will receive risperidone for 8 weeks. Outcome will be assessed using Aberrant Behavior Checklist.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106103930N6
Registration date: 2011-07-08, 1390/04/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-08, 1390/04/17
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-04-22, 1390/02/02
Expected recruitment end date
2012-04-21, 1391/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
N-Acetylcysteine augmentation with Rispridone in treatment of Autism in children: A double blind randomized placebo controlled clinical trial
Public title
N-Acetylcysteine augmentation with Rispridone in treatment of Autism in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: DSM-IV diagnosis of autism spectrum disorders; both gender, aged 3 to 16 years. Exclusion Criteria: primary diagnosis of a psychotic disorder; active substance abuse or dependence; unstable medical condition; prior exposure to N-Acetylcysteine; evidence of active liver disease; seizure disorder; unstable hypertension or cardiac disease; unstable asthma; and kidney disease as determined by the investigator; Weight < 15 kg.
Age
From 3 years old to 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Chamran street- Hafez hospital
City
Shiraz
Postal code
--
Approval date
2011-04-21, 1390/02/01
Ethics committee reference number
CT-90-5545

Health conditions studied

1

Description of health condition studied
Pervasive developmental disorders
ICD-10 code
F84.0
ICD-10 code description
Childhood autism

Primary outcomes

1

Description
Abbrant Behavior Checklist
Timepoint
every 4 week
Method of measurement
interview

Secondary outcomes

1

Description
adverse effects
Timepoint
evey 4 week
Method of measurement
interview

Intervention groups

1

Description
risperidone (0.5 to 3 mg/day)+ Placebo
Category
Placebo

2

Description
N-Acetylcysteine (up to 3000mg/day)+ risperidone (0.5 to 3 mg/day)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Ebrahim Moghimi
Street address
Chamran Street, Hafez hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Zand Street, Shiraz University of Medical sciences- Vice-chancellery of Research Affairs
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
M.D.
Other areas of specialty/work
Street address
Hafez Hospital, Chamran street
City
Fars
Postal code
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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