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| Name | Class |
|---|---|
| The Depressive and Bipolar Disorder Alternative Treatment Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamotrigine | Active Comparator | As adjunct to lithium therapy |
|
| IP6 | Experimental | As adjunct to lithium therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IP6 | Drug | IP6 2,000 -3,000 mg per day given orally in two doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression | As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory | 10 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Morning vs Evening Preference | As measured by the Basic language morningness scale | 10 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J. McCarthy, MD, PhD | VA San Diego Healthcare, UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D010833 | Phytic Acid |
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D007295 | Inositol Phosphates |
| D007294 | Inositol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
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| Lamotrigine | Drug | Dose up to 200 mg per day over 10 weeks |
|
|
| 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 |
| D001519 |
| Behavior |
| D009930 |
| Organic Chemicals |
| D002241 | Carbohydrates |
| D013403 | Sugar Phosphates |
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |