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Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome Clinical research trials and Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome. Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome clinical trial. Human subjects often receive the most effective healthcare possible for their Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome  Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome
Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome
For Condition: Tourette Syndrome
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Yale University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: 7 Years/60 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
BradleyPeterson, Study Chair, Yale University
Additional Information:
Study ID Numbers: 199/12217; YALESM-7764
Study Start Date: July 1997
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004393
Other Tourette Syndrome Studies:
1. Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome
2. Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents
3. Magnetic Resonance Spectroscopy to Evaluate Tourette's Syndrome
4. Brain Tissue Collection for Neuropathological Studies
5. Study of the Neurobiology of Tourette Syndrome and Related Disorders
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Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome
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