Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?



Status:Completed
Conditions:Depression, Depression, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:8/3/2018
Start Date:May 2014
End Date:July 30, 2018

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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.


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)
We found this trial at
1
site
3350 La Jolla Village Dr
San Diego, California 92161
(858) 552-8585
Phone: 858-642-1520
VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
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from
San Diego, CA
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