Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

Bipolar Disorder Clinical Trial

Official title:

Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081287
• Other study ID #: DBDAT-2013-MJM
• Status: Completed
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: July 30, 2018

Study information

• Verified date: July 2018
• Source: San Diego Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Disease
• Manic Depression

Intervention

Drug:
• IP6
IP6 2,000 -3,000 mg per day given orally in two doses
• Lamotrigine
Dose up to 200 mg per day over 10 weeks

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego Veterans Healthcare System	The Depressive and Bipolar Disorder Alternative Treatment Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Morning vs Evening Preference	As measured by the Basic language morningness scale	10 weeks
Primary	Depression	As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory	10 weeks
Secondary	Sleep Quality	As measured by the Pittsburgh Sleep Quality Index	10 weeks
Secondary	Global Function	As measured by the Clinician Global Inventory	10 weeks
Secondary	Side Effect Burden	As measured by standardized inventory	10 weeks
Secondary	Mania	As measured by the Young Mania Scale, and Internal State Scale	10 weeks