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Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents Clinical research trials and Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents. Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents clinical trial. Participants oftentimes recieve the most expert healthcare available for their Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents



Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents

For Condition: Bipolar Disorder
Status: Recruiting
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ,
Synopsis: The purpose of this study is to determine the safety and effectiveness of Risperidone compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Safety/Efficacy Study
Minimum Age/Maximum Age: 10 Years/17 Years
Genders: Both
Protocol Entry Criteria: KEY INCLUSION CRITERIA - Current primary diagnosis of bipolar I disorder, mania or mixed type - Aged between 10 and 17 years of age - Young Mania Rating Scale score greater than or equal to 20 at screening and baseline KEY EXCLUSION CRITERIA - Known or suspected history of substance dependence - Significant risk for suicidal or violent behavior - Antidepressant or clozapine treatment within 4 weeks of baseline - Received a depot antipsychotic within 1 treatment cycle before baseline - Is unable to swallow medication taken in the form of tablets - Has a positive result for a urine drug screen done at baseline - Known or suspected seizure disorder - Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening - Known or suspected history of hypersensitivity or intolerance to risperidone - History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent
Total Enrollment: 

Location and Contact Information:

LSU Health Sciences Center *Recruiting*
Shreveport,  Louisiana,  14760
United States
Recruiting Barbara  Roggero 318-675-6062

Mercy Medical Group *Recruiting*
St. Louis,  Missouri,  63017
United States
Recruiting Elizabeth  Ganser 314-205-0007

Institution for Neuropsychiatry *Recruiting*
Lake Charles,  Louisiana,  70601
United States
Recruiting Susan  Day 337-477-7091

Global Research and Consulting *Recruiting*
Olean,  New York,  14760
United States
Recruiting Kari  Lockwood 716-373-1094

MedLabs Research of Houston *Recruiting*
Houston,  Texas,  77057
United States
Recruiting Julie  Feldott 713-783-8889

Ted Broeck Hospital *Recruiting*
Jacksonville,  Florida,  32216
United States
Recruiting Teresa  Thode 904-724-9203

Cutting Edge Research Group *Recruiting*
Oklahoma City,  Oklahoma,  73120
United States
Recruiting Brooke  Gwynn 405-751-8113

Psychiatric Professional Services *Recruiting*
Cincinnati,  Ohio,  45267
United States
Recruiting Holly  Bryan 513-558-5847

Segal Institute for Clinical Research *Recruiting*
Miami,  Florida,  33161
United States
Recruiting Toby  Harden 305-891-0050

CRCA *Recruiting*
Stone Mountain,  Georgia,  300087
United States
Recruiting Ericka  Copeland 770-465-2459

Millennium Psychiatric Associates *Recruiting*
St. Louis,  Missouri,  63044
United States
Recruiting Kathy  Zervis 314-344-7391

University Hospitals of Cleveland *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Denise  Beyoda 216-844-3881

Centers for Behavioral Health at Maryview *Recruiting*
Portsmouth,  Virginia,  23703
United States
Recruiting Janet  McNiff 757-398-2386


Additional Information:
Study ID Numbers:
  RIS-BIM-301; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076115

Other Bipolar Disorder Studies:
1. Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness

2. Treatment of Depression in Youth with Bipolar Disorders

3. Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients with Bipolar Depression

4. Clinical Trial of Felbamate for Treatment-Resistant Bipolar Depression

5. Brain Tissue Collection for Neuropathological Studies

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Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents

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