NCT02081287

Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: San Diego Veterans Healthcare System · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder
• Manic Depression

Interventions

Type	Name	Description
DRUG	IP6	IP6 2,000 -3,000 mg per day given orally in two doses
DRUG	Lamotrigine	Dose up to 200 mg per day over 10 weeks

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-07-30
• Completion: 2018-07-30
• First posted: 2014-03-07
• Last updated: 2018-08-01

Locations

1 site across 1 country: United States