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Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder Clinical research trials and Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder. Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder
For Condition: Bipolar Disorder
Status: Recruiting
Sponsor(s): Eli Lilly and Company ,
Synopsis: The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 13 Years/17 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained. - Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode. - Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent. - Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Exclusion Criteria: - Female patients who are either pregnant or nursing. - Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder. - Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months. - Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment. - Patients who have been judged clinically to be serious suicidal risks.
Total Enrollment: 130
Location and Contact Information:
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
New York City, New York,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Washington D.C., District of Columbia,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Olean, New York,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Madison, Tennessee,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Little Rock, Arkansas,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Lake Charles, Louisiana,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Beachwood, Ohio,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Chesterfield, Missouri,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Rochester, New York,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician. *Recruiting*
Rio Piedras, ,
Puerto Rico
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Cidra, ,
Puerto Rico
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Vista, California,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Albuquerque, New Mexico,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
San Diego, California,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Atlanta, Georgia,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
San Juan, ,
Puerto Rico
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Las Vegas, Nevada,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Cherry Hill, New Jersey,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Jacksonville, Florida,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Houston, Texas,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Bangor, Maine,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Cerritos, California,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Cincinnati, Ohio,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Boise, Idaho,
United States
Recruiting
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician *Recruiting*
Bellevue, Washington,
United States
Recruiting
Additional Information:
Study ID Numbers: 4360;
Study Start Date: November 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050206
Other Bipolar Disorder Studies:
1. Brain Tissue Collection for Neuropathological Studies
2. Examination of Tamoxifen in Acute Mania in Patients with Bipolar I Disorder
3. Genetic Aspects of Neurologic and Psychiatric Disorders
4. Evaluation of the Genetics of Bipolar Disorder
5. Treatment of Early Age Mania
Related Studies:
Other Bipolar Disorder Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder
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