Study Information: Bipolar Disorder in Children and Teens
Thank you for your interest in this clinical trial.
Finger Lakes Clinical Research (FLCR) is conducting a clinical research trial to study an investigational medication for children and teens, ages 10-17, with Bipolar I Disorder, also known as manic-depressive disorder.
If your child – or the child of a relative or friend – suffers from Bipolar I Disorder, we hope you’ll continue reading, and consider contacting us or informing others who might be interested.You can learn more about bipolar disorder here.
This study, sponsored by Pfizer, will compare the investigational medication with a placebo.
The study drug is ziprazidone, an antipsychotic medication approved by the FDA for treating Bipolar I Disorder and schizophrenia in adults. The purpose of this research study is to determine the safety and efficacy of ziprasidone for treating the same disorder in children.
The study will be placebo-controlled, which means that some participants will receive ziprasidone while others, randomly assigned, will get a placebo, which contains no medication.
Dr. Sarah Atkinson is the principal investigator (PI) for this study. Dr. Atkinson is a board certified psychiatrist with over twenty years’ experience in the field of central nervous system disorders in children and adults.
Participants will come to Finger Lakes Clinical Research (at Twelve Corners in Brighton) for up to 7 visits over approximately 8 weeks. In the first part of the trial, Dr. Atkinson will discuss the study with you or the child’s caregiver, and determine whether this clinical trial is appropriate. If so, the child may be eligible to join the trial.
The final visit at the end of the study will be for follow-up and health checks.
There is no cost to the family, and no insurance is required. Study participants are paid a stipend for each visit, for their time and travel.
Please see the patient information booklet for more information on the study process.
Does the child qualify for this study?
Every clinical study requires that participants meet certain criteria. Dr. Atkinson will need to see potential participants to make a medical determination as to whether the child is able to participate in the study, but you can get a quick idea of whether or not he or she may qualify by answering three questions: