Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

July 30, 2018 updated by: Michael McCarthy, San Diego Veterans Healthcare System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Lamictal
Experimental: IP6
As adjunct to lithium therapy
Drug: IP6
IP6 2,000 -3,000 mg per day given orally in two doses
Other Names:
  • Inositol Hexaphosphate
  • Phytic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 10 weeks
As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: 10 weeks
As measured by the Pittsburgh Sleep Quality Index
10 weeks
Global Function
Time Frame: 10 weeks
As measured by the Clinician Global Inventory
10 weeks
Side Effect Burden
Time Frame: 10 weeks
As measured by standardized inventory
10 weeks
Mania
Time Frame: 10 weeks
As measured by the Young Mania Scale, and Internal State Scale
10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morning vs Evening Preference
Time Frame: 10 weeks
As measured by the Basic language morningness scale
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego Veterans Healthcare System

Collaborators

The Depressive and Bipolar Disorder Alternative Treatment Foundation

Investigators

  • Principal Investigator: Michael J. McCarthy, MD, PhD, VA San Diego Healthcare, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

July 30, 2018

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBDAT-2013-MJM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on Lamotrigine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe