A Phase 1 interventional study of IP6 and Lamotrigine in Bipolar Disorder and Manic Depression, sponsored by San Diego Veterans Healthcare System. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-01.
Sponsored by San Diego Veterans Healthcare System · Phase 1, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 8 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →San Diego Veterans Healthcare System is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
As adjunct to lithium therapy
Drug: Lamotrigine
As adjunct to lithium therapy
Drug: IP6
IP6 2,000 -3,000 mg per day given orally in two doses
Also known as: Inositol Hexaphosphate, Phytic Acid
Dose up to 200 mg per day over 10 weeks
Also known as: Lamictal
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
Morning vs Evening Preference
As measured by the Basic language morningness scale
Time frame: 10 weeks
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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San Diego Veterans Healthcare System