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Protocol summary
Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder children between the ages of 12 and 17 years old; presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone). Exlusion criteria: presence of any active medical problem other psychiatric diagnosis except for mild to moderate Intellectual disability receiving any antipsychotic medications during past monthprior to the trial severe hepatic disease history of allergy to risperidone and intolerance of it; history of seizure requiring change of antiepileptic dose during the last month seizure during the last 6 months.
Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder children between the ages of 11 and 17 years old; presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone). Exlusion criteria: presence of any active medical problem other psychiatric diagnosis except for mild to moderate Intellectual disability receiving any antipsychotic medications during past monthprior to the trial severe hepatic disease history of allergy to risperidone and intolerance of it; history of seizure requiring change of antiepileptic dose during the last month seizure during the last 6 months.
Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder children between the ages of 1211 and 17 years old; presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone). Exlusion criteria: presence of any active medical problem other psychiatric diagnosis except for mild to moderate Intellectual disability receiving any antipsychotic medications during past monthprior to the trial severe hepatic disease history of allergy to risperidone and intolerance of it; history of seizure requiring change of antiepileptic dose during the last month seizure during the last 6 months.
ملاکهای ورود: داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک سن 12 تا 17سال وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد، ملاکهای خروج: هر گونه بیماری مدیکال فعال وجود تشخیص روانپزشکی دیگری بغیر از عقب ماندگی ذهنی خفیف تا متوسط مصرف هر گونه داروی آنتی سایکوتیک حداقل یک ماه قبل از پژوهش اختلال کبدی شدید سابقه حساسیت قبلی به ریسپریدون وعدم تحمل دارو سابقه تشنجی که در یکماه اخیر دوز دارو جهت کنترل تشنج تغییر کرده باشد در 6ماه اخیر تشنج داشته باشد
ملاکهای ورود: داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک سن 11 تا 17سال وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد، ملاکهای خروج: هر گونه بیماری مدیکال فعال وجود تشخیص روانپزشکی دیگری بغیر از عقب ماندگی ذهنی خفیف تا متوسط مصرف هر گونه داروی آنتی سایکوتیک حداقل یک ماه قبل از پژوهش اختلال کبدی شدید سابقه حساسیت قبلی به ریسپریدون وعدم تحمل دارو سابقه تشنجی که در یکماه اخیر دوز دارو جهت کنترل تشنج تغییر کرده باشد در 6ماه اخیر تشنج داشته باشد
ملاکهای ورود: داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک سن 1211 تا 17سال وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد، ملاکهای خروج: هر گونه بیماری مدیکال فعال وجود تشخیص روانپزشکی دیگری بغیر از عقب ماندگی ذهنی خفیف تا متوسط مصرف هر گونه داروی آنتی سایکوتیک حداقل یک ماه قبل از پژوهش اختلال کبدی شدید سابقه حساسیت قبلی به ریسپریدون وعدم تحمل دارو سابقه تشنجی که در یکماه اخیر دوز دارو جهت کنترل تشنج تغییر کرده باشد در 6ماه اخیر تشنج داشته باشد
General information
12
11
1211
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change age
change age
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تغییر سن
تغییر سن
DSM-5 clinical diagnosis of autistic disorder
Teenagers between the ages of 12and 17 years old
Presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
DSM-5 clinical diagnosis of autistic disorder
Teenagers between the ages of 11and 17 years old
Presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
DSM-5 clinical diagnosis of autistic disorder Teenagers between the ages of 12and11and 17 years old Presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک
سن 12 تا 17 سال
وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد
داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک
سن 11 تا 17 سال
وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد
داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک سن 1211 تا 17 سال وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد
Primary outcomes
#1
Baseline and weeks 4, 8 and 10
Baseline and weeks 5, and 10
Baseline and weeks 45, 8 and 10
ابتدای مطالعه و هفته 4 و 8 و 10
ابتدای مطالعه و هفته 5 و 10
ابتدای مطالعه و هفته 4 و 85 و 10
By Aberrant Behavior Checklist-Community( ABC-C) and Childhood Autism Rating scale( CARS)
By Aberrant Behavior Checklist-Community( ABC-C)
By Aberrant Behavior Checklist-Community( ABC-C) and Childhood Autism Rating scale( CARS)
بوسیله مقیاس چک لیست رفتارهای نابهنجار(ABC-C) و مقیاس درجه بندی اوتیسم( CARS)
بوسیله مقیاس چک لیست رفتارهای نابهنجار(ABC-C)
بوسیله مقیاس چک لیست رفتارهای نابهنجار(ABC-C) و مقیاس درجه بندی اوتیسم( CARS)
Recruitment centers
#1
Name of recruitment center - English: Roozbeh hospital
Name of recruitment center - Persian: بيمارستان روزبه
Full name of responsible person - English: Prof. M.R. Mohammadi
Full name of responsible person - Persian: دکتر محمد رضا محمدی
Street address - English: Roozbeh Hospital, South Kargar Street,
Street address - Persian: کارگر جنوبی بیمارستان روزبه
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1333715914
Phone: +98 21 5541 2222
Fax:
Email: mohammadimr@tums.ac.ir
Web page address:
Name of recruitment center - English: Roozbeh hospital
Name of recruitment center - Persian: بيمارستان روزبه
Full name of responsible person - English: Prof. Mohammad Reza Mohammadi
Full name of responsible person - Persian: دکتر محمد رضا محمدی
Street address - English: Roozbeh Hospital, South Kargar Street,
Street address - Persian: کارگر جنوبی بیمارستان روزبه
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1333715914
Phone: +98 21 5541 2222
Fax:
Email: mohammadimr@tums.ac.ir
Web page address:
Name of recruitment center - English: Roozbeh hospital Name of recruitment center - Persian: بيمارستان روزبه Full name of responsible person - English: Prof. M.R.Mohammad Reza Mohammadi Full name of responsible person - Persian: دکتر محمد رضا محمدی Street address - English: Roozbeh Hospital, South Kargar Street, Street address - Persian: کارگر جنوبی بیمارستان روزبه City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1333715914 Phone: +98 21 5541 2222 Fax: Email: mohammadimr@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Ali Sahraian
Full name of responsible person - Persian: دکتر محمدعلی صحراییان
Street address - English: Keshavarz Blvd
Street address - Persian: بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8898 7381
Fax:
Email: msahrai@tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Ali Sahraian
Full name of responsible person - Persian: دکتر محمدعلی صحراییان
Street address - English: Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
Street address - Persian: بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8898 7381
Fax:
Email: msahrai@tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Mohammad Ali Sahraian Full name of responsible person - Persian: دکتر محمدعلی صحراییان Street address - English: Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Street address - Persian: بلوار کشاورز City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 8898 7381 Fax: Email: msahrai@tums.ac.ir Web page address:
Protocol summary
Study aim
The objective of this study is to assess the efficacy of pregnenolon in the treatment of autism
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be conducted among children with autistic disorder attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder children between the ages of 11 and 17 years old; presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone). Exlusion criteria: presence of any active medical problem other psychiatric diagnosis except for mild to moderate Intellectual disability receiving any antipsychotic medications during past monthprior to the trial severe hepatic disease history of allergy to risperidone and intolerance of it; history of seizure requiring change of antiepileptic dose during the last month seizure during the last 6 months.
Intervention groups
The participants will be randomly allocated into two groups. Intervention group(20 persons) will receive pregnenolon (100 mg BID) and risperidone ( 2.5 to 3.5 mg per day) and control group( 20 persons) will receive risperidone( 2.5 to 3.5 mg per day) for 10 weeks.
Main outcome variables
Severity of autism
General information
Reason for update
change age
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N112
Registration date:2018-07-25, 1397/05/03
Registration timing:prospective
Last update:2020-04-10, 1399/01/22
Update count:1
Registration date
2018-07-25, 1397/05/03
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-05, 1397/05/14
Expected recruitment end date
2021-08-05, 1400/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of pregnenolon in treatment of irritability in teeanagers with autism;A double blind and placebo controlled triall
Public title
Efficacy of pregnenolon in treatment of irritability inteeanagers with autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
DSM-5 clinical diagnosis of autistic disorder
Teenagers between the ages of 11and 17 years old
Presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
Exclusion criteria:
Presence of any active medical problem
Other psychiatric diagnosis except for mild to moderate Intellectual disability
Receiving any antipsychotic medications during past monthprior to the trial
Severe hepatic disease
History of allergy to risperidone and intolerance of it
History of seizure requiring change of antiepileptic dose during the last month
Seizure during the last 6 months
Age
From 11 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random permuted block
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome raters will be blind regarding grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
IR.TUMS.VCR.REC.1397.221
Health conditions studied
1
Description of health condition studied
Autistic disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Severity of autism
Timepoint
Baseline and weeks 5, and 10
Method of measurement
By Aberrant Behavior Checklist-Community( ABC-C)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cap. ُ( 100 BID) plus Risperidone ( 2.5 to 3.5 mg per day) for 10 weeks
Category
Treatment - Drugs
2
Description
Control group: tablet placebo plus Risperidone( 2.5 to 3.5 mg per day) for 10 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Prof. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street,
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
شاهین آخوندزاده
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
En 5 years from 2021 to 2026
To whom data/document is available
academic researchers
Under which criteria data/document could be used
users should cite the resource of data
From where data/document is obtainable
Prof Shahin Akhondzadeh
What processes are involved for a request to access data/document