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Oral Risperidone and Clonidine in children with tics

Not Applicable
Conditions
Health Condition 1: G968- Other specified disorders of central nervous system
Registration Number
CTRI/2020/07/026505
Lead Sponsor
All India Institute of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Aged 6 to 18 years and weight of at least 15 kg

2. Has motor and/or vocal tics and requiring medication

3. If female, not sexually active

4. Medication free or adequate washout period (2 weeks prior to enrollment) of psychoactive drugs

Exclusion Criteria

1. Any other co-morbid neuropsychiatric problems other than ADHD and OCD

2. Prior use of risperidone or clonidine for more than 2 weeks in last one month

3. Seizure during the past 6 months

4. History or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments during the trial including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, hematologic or immunologic disease as determined by the clinical judgment of the investigator

5. Current suicidal or homicidal risk

6. Dependent on other substances, with the exception of nicotine or caffeine

7. Females who are found to be sexually active and are not willing to use oral contraceptives

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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