Study information: Bipolar Depression (Intracellular)
We appreciate your interest in learning more about participating in this clinical trial.
Finger Lakes Clinical Research (FLCR) is conducting a clinical research study to look at whether an investigational medication can improve the symptoms of bipolar depression (both bipolar I or bipolar II disorders). If you or a loved one suffers from bipolar depression, we hope you’ll continue reading, and consider contacting us.
The study, sponsored by Intra-Cellular Technologies, consists of two independent, but closely-related trials, referred to as “401” and “402,” for short
For bipolar I and bipolar II patients who are currently depressed, and are not on medications, or whose current medication isn’t working.
For bipolar I and bipolar II patients who are currently depressed, and are taking Lithium or Depakote (Valproic Acid)
Participants will come to Finger Lakes Clinical Research (at Twelve Corners in Brighton) for nine visits over approximately 12 weeks. In the first part of the trial, Dr. Atkinson will discuss the study with you or your loved one to determine if this study is appropriate. If so, the participant may join one of the treatment groups and begin taking the study medication (or a placebo). The final visits at the end of the study will be for follow-up and health checks.
There is no cost to the participant and no insurance is required. Study participants are paid a stipend for each visit.
Please see the patient information booklet for more detailed information on the study process.
Do you qualify for this study?
Every clinical study requires that participants meet certain criteria, and the information booklet gives some basic qualification guidelines for this study. 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: