Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Lamotrigine As adjunct to lithium therapy |
Drug: Lamotrigine
Dose up to 200 mg per day over 10 weeks
Other Names:
|
| Experimental: IP6 As adjunct to lithium therapy |
Drug: IP6
IP6 2,000 -3,000 mg per day given orally in two doses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Depression [10 weeks]
As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory
Secondary Outcome Measures
- 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 Outcome Measures
- Morning vs Evening Preference [10 weeks]
As measured by the Basic language morningness scale
Eligibility Criteria
Criteria
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:
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA San Diego Healthcare System | San Diego | California | United States | 92161 |
Sponsors and Collaborators
- San Diego Veterans Healthcare System
- The Depressive and Bipolar Disorder Alternative Treatment Foundation
Investigators
- Principal Investigator: Michael J. McCarthy, MD, PhD, VA San Diego Healthcare, UCSD
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DBDAT-2013-MJM