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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
IP6 2,000 -3,000 mg per day given orally in two doses
Dose up to 200 mg per day over 10 weeks
VA San Diego Healthcare System
San Diego, California, United States
Depression
As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory
Time frame: 10 weeks
Sleep Quality
As measured by the Pittsburgh Sleep Quality Index
Time frame: 10 weeks
Global Function
As measured by the Clinician Global Inventory
Time frame: 10 weeks
Side Effect Burden
As measured by standardized inventory
Time frame: 10 weeks
Mania
As measured by the Young Mania Scale, and Internal State Scale
Time frame: 10 weeks
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