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Investigation of the efficacy of Risperidone in the treatment of developmental stuttering in Persian-speaking children aged 5 to 10 years

Investigation of the efficacy of Risperidone in the treatment of developmental stuttering in Persian-speaking children aged 5 to 10 years

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240527061909N1
Enrollment
30
Registered
2024-07-29
Start date
2024-08-22
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stuttering. Childhood onset fluency disorder

Interventions

Intervention 1: Intervention group:Intervention group: Patients in the drug group were treated with risperidone with a nightly unit dose of half a milligram and a maximum nightly unit dose of up to tw

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Age range from 5 to 10 years 2. Having a diagnosis of developmental stuttering disorder based on the score of the SSI-3 test and the therapist's speech diagnosis 3. Absence of any language, speech or reading disorders other than stuttering 4. Absence of any kind of neurological, movement, vision, hearing, mental-cognitive problems in the past or present 5. Not taking drugs affecting cognitive function or stuttering, in the last month or during research 6. Absence of history of speech therapy treatment at least in the last 3 months

Exclusion criteria

Exclusion criteria: The individual's unwillingness to cooperate in any stage of the research.

Design outcomes

Primary

MeasureTime frame
Assessment of stuttering severity using the SSI-3 measurement tool by an evaluator (experienced speech therapist) and the SR score by the individual at the beginning of the study, 4 weeks and 10 weeks after the start of treatment during a visit to the clinic. Timepoint: Zero, 4 and 10 weeks. Method of measurement: SSI-3 SR self-report form, AIMS, Connors hyperactivity test.

Secondary

MeasureTime frame
Investigating the severity of stuttering using the SSI-3 measurement tool and the SR score. Timepoint: zero, four and ten weeks after the start of treatment. Method of measurement: Stuttering Severity Instrument-3.;Investigating the duration of recovery of stuttering based on SR and SSI-3 scores. Timepoint: zero, four and ten weeks after the start of treatment. Method of measurement: Self-Report Self-Report Form - Connors Hyperactivity.;Investigating age and gender differences in the group receiving risperidone. Timepoint: zero, four and ten weeks after the start of treatment. Method of measurement: Abnormal Involuntary Movement Scale (AIMS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Arman Masoodi

Babol University of Medical Sciences

armonmasoodi@mubabol.ac.ir+98 11 3222 3594

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026