Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004393

Enrollment

Registered

1999-10-19

Start date

1997-07-31

Completion date

2000-09-30

Last updated

2005-06-24

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

Conditions

Tourette Syndrome

Keywords

Tourette syndrome, neurologic and psychiatric disorders, rare disease

Brief summary

OBJECTIVES: I. Conduct a randomized, double blind, placebo controlled, parallel study of the atypical neuroleptic risperidone (RIS) in the treatment of children and adults with moderate to severe Tourette Syndrome. II. Evaluate further the safety of RIS in this population.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Initially, all patients receive placebo capsules twice daily in a single blind fashion during the first 2 weeks of study. Then, patients are randomized to receive either risperidone (RIS) or placebo for 8 weeks. The dose of RIS is increased weekly over the first 4 weeks of treatment, as tolerated. Patients continue RIS for 4 additional weeks at the dose prescribed during week 4. All patients receive diagnostic evaluations at the beginning and end of the 2 week initial single blind phase, and at the end of weeks 2, 4, 6, and 8 of the active treatment phase.

Interventions

DRUGrisperidone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

7 Years to 60 Years

Healthy volunteers

Inclusion criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- DSM-IV diagnosis of Tourette Syndrome (TS) Tic symptoms greater than 3 (moderate or worse) on the Global Clinical Impression Scale for TS --Prior/Concurrent Therapy-- No concurrent use of other medications during study A minimum of 4 weeks since prior use of other medications and 8 weeks for neuroleptics or fluoxetine --Patient Characteristics-- Hepatic: No hepatic disease Renal: No renal disease Cardiovascular: * No heart disease * No hypertension Pulmonary: No pulmonary disease Other: * Not pregnant * IQ at least 70 required * No other movement disorder allowed, such as tardive dyskinesia * No major depression * No pervasive developmental disorder * No autism or psychotic disorder based on DSM-IV * No alcohol or substance abuse * No hypersensitivity to risperidone * All subjects must be in good health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026