Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?
Status:
Completed
Trial end date:
2018-07-30
Target enrollment:
Participant gender:
Summary
Inositol hexaphosphate (IP6, also called inositol hexakisphosphate, and phytic acid) is a
naturally occurring phosphorylated derivative of myo-inositol. Myo-inositol has shown
preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in
bipolar disorder in some studies, but failed to establish efficacy in subsequent
meta-analyses. In the investigators proposed work, the investigators plan to orally
administer the calcium/magnesium salt of IP6 (2,000-3,000 mg daily in two divided doses) to
paid research subjects with a diagnosis of bipolar disorder who are in a depressed state, and
who have failed an adequate course of treatment with lithium monotherapy. The investigators
hypothesis is that IP6 may be similar to myo-inositol in terms of relieving depression, but
more potent and effective. Our aim is conduct a preliminary pilot study in 30 subjects (15
treated with IP6, 15 treated with lamotrigine, an active comparator) to assess the efficacy
and tolerability of IP6 as an adjunctive treatment to lithium, the mood stabilizer most
commonly used to treat bipolar disorder.
Phase:
Phase 1
Details
Lead Sponsor:
San Diego Veterans Healthcare System
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation