Bipolar Disorder, Manic Depression
Conditions
Keywords
Bipolar Disorder, Depression, Inositol, Inositol Hexaphosphate, Phytic Acid, IP6, Lithium, Lamotrigine
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.
Interventions
DRUGIP6
IP6 2,000 -3,000 mg per day given orally in two doses
DRUGLamotrigine
Dose up to 200 mg per day over 10 weeks
Sponsors
The Depressive and Bipolar Disorder Alternative Treatment Foundation
San Diego Veterans Healthcare System
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 10 weeks | As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Morning vs Evening Preference | 10 weeks | As measured by the Basic language morningness scale |
Countries
United States
Outcome results
None listed