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The Efficacy of Risperidone in treatment of Developmental stuttering in Persian adolescents aged 12-18 years old

Protocol summary

Study aim
The Efficacy of Risperidone in treatment of Developmental stuttering in Persian adolescents aged 12-18 years old
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 30 patients, with baseline, two-week and six-week follow-up
Settings and conduct
Method: Patients are divided into two groups receiving risperidone and placebo. The method of assigning patients to two groups will be randomly using permutation blocks. It starts with a dose of 0.25 mg at night, then after a week it is increased to 1 mg at night. The duration of treatment is 6 weeks. The stuttering severity of the patients before starting the medication, two weeks and 6 weeks after starting the medication is measured, recorded and collected using the SSI-3 stuttering severity tool and the SR score. Place: psychiatric clinics affiliated to Babol University of Medical Sciences Blinding: risperidone and placebo tablets (one gram of maltodextrin) will be prepared with the same color, smell and shape.
Participants/Inclusion and exclusion criteria
log in: 1. Age = 12 to 18 years 2. Farsi language 3. Be literate in reading and writing 4. Having a diagnosis of permanent developmental stuttering disorder 5. Absence of any language disorder, speech other than stuttering 6. Absence of any kind of neurological, movement, vision, hearing, mental retardation and autism spectrum disorders in the past or present, except for hyperactivity and attention deficit 7. Not taking drugs affecting cognitive function before or during the research Exit: 1. Loss of entry requirements 2. The person's unwillingness to cooperate in every stage of the research
Intervention groups
case group: receiving Risperidone drug control group:receiving Placebo drug(Maltodextrin)
Main outcome variables
Overall score of stuttering severity, stuttering frequency, stuttering duration, stuttering behaviors, SR score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240410061463N1
Registration date: 2024-05-25, 1403/03/05
Registration timing: prospective

Last update: 2024-05-25, 1403/03/05
Update count: 0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Mahsa Mahdiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7795 1964
Email address
mahdianimahsa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Risperidone in treatment of Developmental stuttering in Persian adolescents aged 12-18 years old
Public title
The Efficacy of Risperidone in treatment of Developmental stuttering in Persian adolescents aged 12-18 years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 12 to 18 years Persian language Be literate in reading and writing Having a diagnosis of permanent developmental stuttering disorder based on the following criteria, the presence of both criteria is necessary: ​​• Diagnosis of developmental stuttering by an experienced speech and language pathologist at the time of study • Obtaining a total score of 12 or higher in Riley's Stuttering Severity Test (SSI- 3) Absence of any language or speech disorder other than stuttering in the past or present (will be checked by self-reporting by each participant) Absence of any type of neurological, movement, vision, hearing, mental retardation, and autism spectrum disorders in the past or present, except for attention deficit hyperactivity disorder (ADHD) (with a clinical diagnosis by a psychiatrist) Not taking drugs affecting cognitive function before or during the research (self-reporting will be checked by each participant)
Exclusion criteria:
The person's unwillingness to cooperate in every stage of the research
Age
From 12 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups receiving risperidone and placebo. The randomization sequence will be done using the seadenvelop.com website and by the design methodologist. The method of assigning patients to two groups will be randomly with permutation blocks. The size of the blocks is 4 and 2, the ratio of drug and placebo in each block is considered 1:1.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to hide the treatment process, a random code is assigned to each of the two drug or placebo groups in the generated sequence list. When each person enters the study, a code is announced to the researcher, and the drug or placebo corresponding to that random code is given to the patient, and the said random code is recorded on the patient's file. If side effects are observed, the random code will be unlocked. Otherwise, the codes will be unlocked at the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
address Modares Street, Shahid Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713655647
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.189

Health conditions studied

1

Description of health condition studied
stuttering
ICD-10 code
F98.5
ICD-10 code description
Adult onset fluency disorder

Primary outcomes

1

Description
- The primary outcome of the study includes the improvement of stuttering severity using the SSI-3 measurement tool and the SR score by the individual at the beginning of the study, two weeks and six weeks after the start of treatment during a visit to the clinic.
Timepoint
At the beginning of the study, two weeks and six weeks after the start of the treatment, it is during a visit to the clinic.
Method of measurement
The primary outcome of the study includes the improvement of stuttering severity using the SSI-3 measurement tool and the SR score by the individual at the beginning of the study, two weeks and six weeks after the start of treatment during a visit to the clinic.

Secondary outcomes

1

Description
- Secondary outcome is determined by measuring the side effects of drug use based on the AIMS questionnaire by a psychiatric assistant in two weeks and six weeks after the start of treatment.
Timepoint
in two weeks and six weeks after the start of treatment.
Method of measurement
is determined by measuring the side effects of drug use based on the AIMS questionnaire by a psychiatric assistant

Intervention groups

1

Description
Intervention group: Resperidone 1 mg tablet of Sobhan company starts with a dose of 0.25 mg at night, then after a week it is increased to 1 mg at night. The duration of treatment is 6 weeks.
Category
Treatment - Drugs

2

Description
Control group: Placebo in the form of maltodextrin, which is a kind of harmless starch, and is prepared in the form of 1 mg tablets with the same taste and smell as risperidone tablets, and it starts with a dose of 0.25 mg at night, then after a week to 1 mg is given at night. The duration of treatment is 6 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Yahyanejad Hospital
Full name of responsible person
Dr Mahsa Mahdiani
Street address
addresModares Street, Shahid Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713655647
Phone
+98 11 3229 1951
Fax
+98 11 3229 1951
Email
mahdianimahsa@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahdi Rajabnia
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
ramazan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Arman Masoudi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Modares Street, Shahid Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713655647
Phone
+98 11 3229 1951
Fax
+98 11 3229 1951
Email
armonmassoodi@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Arman Masoudi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Modares Street, Shahid Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713655647
Phone
+98 11 3229 1951
Fax
+98 11 3229 1951
Email
armonmassoodi@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahsa Mahdiani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Modares Street, Shahid Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713655647
Phone
+98 11 3229 1951
Fax
+98 11 3229 1951
Email
mahdianimahsa@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document
There is no further information
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