Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
Summary
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Bipolar Disorder
Intervention
Olanzapine, Placebo
Location
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
Indianapolis
Indiana
United States
Status
Completed
Source
Eli Lilly and Company
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00050206
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:52:34-0400
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Medical and Biotech [MESH] Definitions
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Quetiapine Fumarate
A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.
Lithium
An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight 6.94. Salts of lithium are used in treating BIPOLAR DISORDER.
Retinal Bipolar Cells
INTERNEURONS of the vertebrate RETINA containing two processes. They receive inputs from the RETINAL PHOTORECEPTOR CELLS and send outputs to the RETINAL GANGLION CELLS. The bipolar cells also make lateral connections in the retina with the RETINAL HORIZONTAL CELLS and with the AMACRINE CELLS.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
