Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

Study Overview
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Brief Summary
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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.

Official Title
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Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

Conditions
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Bipolar Disorder, Manic Depression

Intervention / Treatment
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* Drug: IP6
* Drug: Lamotrigine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lamotrigine<br>As adjunct to lithium therapy | Drug: Lamotrigine<br>* Dose up to 200 mg per day over 10 weeks<br>* Other names: Lamictal;|
| Experimental: IP6<br>As adjunct to lithium therapy | Drug: IP6<br>* IP6 2,000 -3,000 mg per day given orally in two doses<br>* Other names: Phytic Acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | As measured by the Pittsburgh Sleep Quality Index | 10 weeks | 
| Global Function | As measured by the Clinician Global Inventory | 10 weeks | 
| Side Effect Burden | As measured by standardized inventory | 10 weeks | 
| Mania | As measured by the Young Mania Scale, and Internal State Scale | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder, Depression, Inositol, Inositol Hexaphosphate, Phytic Acid, IP6, Lithium, Lamotrigine