Effect of levetiracetam on intracellular calcium signaling in blood platelets of patients with bipolar disorder
P.I. Dr. Dubovsky
Co-Investigator: Dr. Yogesh Bakhai
Externally Sponsored Research: UCB-Pharma

In view of the accumulating evidence of a dysregulation of [Ca²⁺]_i signaling in both poles of bipolar disorder and of its correction by at least some mood stabilizing medications, and of the thymoleptic effects of some Ca²⁺  antagonists, it appears reasonable to examine the effects of potential new mood stabilizing agents on intracellular Ca²⁺ signaling. For new medications with Ca²⁺ channel blocking properties, it is important to determine whether these properties translate into normalization of a hyperactive Ca²⁺ signal. In this study we will test the hypothesis that the N-channel antagonist levetiracetam normalizes [Ca²⁺]_i in platelets of unmedicated affectively ill patients with mania, bipolar depression, or mixed states.

Prevalence of Bipolar Disorder in Family Practice
P.I. Dr. Griswold  & Co P.I. Dr. Linda Pessar
Consultant: Dr. Dubovsky

Bipolar disorder is under-recognized and inadequately treated in primary care, resulting in worsening of symptoms, decreased levels of functioning, and increased risk of suicide. This project is using a practice-based research network to estimate the prevalence of bipolar disorder in family practice. Simultaneously, a diagnostic instrument called the M.I.N.I is tested for its usefulness in primary care. The overall goal of this project is to identify appropriate screening methods in order to make early and correct diagnosis of the bipolar spectrum of disorders in primary care.

Four Week, Double-Blind, Placebo-Controlled Phase III Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Flexible Doses of Oral Ziprasidone in Children and Adolescent Subjects with Bipolar I Disorder (Manic or Mixed)  (A1281132)
Principal Investigator: David Kaye, MD
Sponsor: Pfizer

26-Week Open-Label Extension Study Evaluating the Safety and  Tolerability of Flexible Doses of Oral Ziprasidone in Children and Adolescents with Bipolar I Disorder (Manic or Mixed) (A1281133)
Principal Investigator: David Kaye, MD
Sponsor: Pfizer

Six Week, Double-Blind, Placebo-Controlled Phase III Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Flexible Doses of Oral Ziprasidone in Adolescent Subjects with Schizophrenia (A1281134)
Principal Investigator: David Kaye, MD
Sponsor: Pfizer

A Phase 3, Randomized, 6-month, Double-blind Trial in Subjects with Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone plus a Mood Stabilizer  (VS Placebo plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-label Treatment with Both Agents  (A1281137)
Principal Investigator: Steven Dubovsky, MD
Sponsor: Pfizer

A Three -Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral Ziprasidone in Subjects with Acute Mania Treated with Lithium or Divalproex (A1281143)
Principal Investigator: Steven Dubovsky, MD
Sponsor: Pfizer