Health Condition 1: G968- Other specified disorders of central nervous system
Conditions
Interventions
Intervention1: Arm A oral Risperidone: 1. 2 weeks placebo phase followed by 8 weeks intervention phase
2. If the patient responds to the placebo trial, than he will be excluded from enrolment in the s
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in YGTSS score from baseline after 8 weeks of drug treatment in both armsTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Yale-Brown obsessive compulsive scale (Y-BOCS)Timepoint: 8 weeks;b. Connorâ??s parent rating scale-revised, 3rd edition (CPRS-R)Timepoint: 8 weeks;c. Tic-CGI-S scoreTimepoint: 8 weeks;d. TS-CGI-S scoreTimepoint: 8 weeks;e. OCD-CGI-S scoreTimepoint: 8 weeks;f. MOVES scoreTimepoint: 8 weeks;g. PUTS scoreTimepoint: 8 weeks;h. Simpson Angus rating scale-EPSTimepoint: 8 weeks;i. Childhood Depression Rating Scale-revised (CDRS-R)Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Indar Kumar Sharawat
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed