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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

risperidone

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette syndrome, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

7 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004393

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT00004393

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2001

Overall Recruitment Status

Completed

Study Start Date

July 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Yale University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tourette Syndrome

Keywords

Tourette syndrome, neurologic and psychiatric disorders, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

50 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

risperidone

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bradley S. Peterson

Organizational Affiliation

Yale University

Official's Role

Study Chair

Tourette Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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