Patients with Bipolar Disorder
Protocol: STUDY00004251
Full Title
Effect of lithium on intracellular calcium signaling in blood platelets of patients with bipolar disorder
Description
This study enrolls adults with bipolar disorder that is currently not well controlled who will be starting treatment. The purpose of the research is to learn about the relationship between changes in the amount of calcium in platelets and mood change in people with bipolar disorder.

We have found the level of calcium inside a type of blood cell called a platelet is increased in some bipolar people when they are depressed or manic, but not when they are well. This kind of calcium is not affected by how much calcium you take in. Calcium inside cells in the brain is important because it controls many aspects of brain function that are affected in mood disorders. The purpose of the research is to learn about the relationship between changes in the amount of calcium in those cells and mood change in people with bipolar disorder.

You will be in the study for a total of 3.5 hours over the course of two study visits. The two study visits will be scheduled 8 to 12 weeks apart. You will be asked to give 2 blood samples and answer some questions about your mood and health.

Technical Description

1. To determine whether in vitro incubation with lithium is associated with normalization of elevated free intracellular calcium concentration ([Ca2+]i) in blood platelets of affectively ill patients with mania, bipolar depression, or mixed states.
2. To determine whether normalization of elevated [Ca2+]i by lithium in affectively ill patients with mania, bipolar depression, or mixed states is correlated with clinical improvement of acute mood illness, as measured by the Clinical Global Impression scale - Severity (CGI-S), Clinical Global Impression scale Improvement (CGI-I), Montgomery-sberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMR) over at least 8 weeks of standard of care (SOC) treatment with any mood stabilizer.
3. To assess whether clinical improvement of acute mood illness, as measured by the CGI-S, CGI-I, MADRS, and YMRS over at least 8 weeks of SOC treatment treatment with any mood stabilizer is associated with a normalization of elevated [Ca2+]i in affectively ill patients with mania, bipolar depression, or mixed states.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Adults ages 18-75
Healthy, diagnosed with bipolar disorder (mania, bipolar depression, or mixed state)
Acutely ill and initiating a new standard of care treatment for their bipolar disorder
Age Group: Adults
Principal Investigator: STEVEN DUBOVSKY
Contact(s)
ELSA DAURIGNAC
ecd3@buffalo.edu
+1 716-898-5941
Want to Learn More?
Enrollment Update

Due to COVID-19, new enrollment in research studies will be greatly limited. If you are interested in a study, there may be a longer waiting period to receive a response to your inquiry. View the guidance for research participants for additional information.

Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.