Study information: Bipolar Depression (Allergan)
This clinical trial is for adults who have been diagnosed with bipolar I disorder.
We are conducting a clinical research study to look at whether an investigational medication can improve the symptoms of bipolar depression (bipolar I disorder). If you or a loved one suffers from this illness, we hope you’ll continue reading, and consider speaking with us.
Allergan wants to determine whether this study drug will help improve symptoms of bipolar I depression in adults. The study drug is currently approved by the FDA for treatment of other disorders and symptoms, but not yet for treating bipolar 1 depression. This clinical trial will compare the investigational medication to a placebo, which has no active ingredients.
Finger Lakes Clinical Research (FLCR) is one of approximately 85 worldwide sites selected by Allergan to conduct this study. Dr. Sarah Atkinson is the principal investigator (PI) for this trial. She is a board certified psychiatrist with over twenty years’ experience in the field of central nervous system disorders.
How is the clinical trial conducted?
Participants will come to our office (at Twelve Corners in Brighton) for seven visits over approximately nine weeks. The first visit will be to determine whether one qualifies for the study. If so – and if he or she wishes to continue – the participant will begin taking either the (oral) study medication, or a placebo. Approximately two-thirds of participants will get the investigational drug, and one-third will get a placebo. Neither the study team, nor participants, know who is taking the investigational medication and who is taking the placebo.
During clinic visits, participants will have their health and condition monitored with medical/laboratory tests and questionnaires.
There is no cost to the participant and no insurance is required. Study participants are paid a stipend for their time and travel.
Do you qualify for this study?
Every clinical study requires that participants meet certain criteria. Dr. Atkinson will need to see you to make a medical determination as to whether you are able to participate in the study, but you can get a quick idea of whether or not you may qualify by taking this short self-quiz: