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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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
VA San Diego Healthcare System
San Diego, California, United States
Start Date
May 1, 2014
Primary Completion Date
July 30, 2018
Completion Date
July 30, 2018
Last Updated
August 1, 2018
8
ACTUAL participants
IP6
DRUG
Lamotrigine
DRUG
Lead Sponsor
San Diego Veterans Healthcare System
Collaborators
NCT04480918
NCT07140913
Data Source & Attribution
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