Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

NCT02081287 — Phase 1, Completed, 8 participants, San Diego Veterans Healthcare System

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Registry	NCT02081287
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	8 (Actual)
Sponsor	San Diego Veterans Healthcare System (Fed); collaborators: The Depressive and Bipolar Disorder Alternative Treatment Foundation
Conditions	Bipolar Disorder, Manic Depression
Interventions	IP6, Lamotrigine (Drug)
Dates	start 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 in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Lamotrigine	Active comparator	Drug: Lamotrigine	As adjunct to lithium therapy
IP6	Experimental	Drug: IP6	As adjunct to lithium therapy

IP6 (Drug), also known as Inositol Hexaphosphate, Phytic Acid: IP6 2,000 -3,000 mg per day given orally in two doses
Lamotrigine (Drug), also known as Lamictal: Dose up to 200 mg per day over 10 weeks

+Outcome measures

Primary outcomes

Depression [10 weeks]: As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory

Secondary outcomes

Sleep Quality [10 weeks]: As measured by the Pittsburgh Sleep Quality Index
Global Function [10 weeks]: As measured by the Clinician Global Inventory
Side Effect Burden [10 weeks]: As measured by standardized inventory
Mania [10 weeks]: As measured by the Young Mania Scale, and Internal State Scale

Other outcomes

Morning vs Evening Preference [10 weeks]: As measured by the Basic language morningness scale

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* must have bipolar disorder
* must be currently depressed
* must have failed adequate trial of lithium monotherapy
* must have shown partial response of depression to lithium

Exclusion Criteria:

* diagnoses of schizophrenia, major depression, or other psychotic disorder
* currently pregnant
* unstable medical condition
* active drug or alcohol dependence
* concurrent use of antidepressant or mood stabilizer other than lithium
* active suicidal or homicidal ideation
* past adverse reaction to lamotrigine or current skin rash (lamotrigine arm only)
* history of dietary malabsorption or nutritional deficiency (IP6 arm only)

+Locations (1)

Facility	City	Country	Status
VA San Diego Healthcare System	San Diego, California	United States

+Investigators

Michael J. McCarthy, MD, PhD, Principal investigator, VA San Diego Healthcare, UCSD