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Clinical Trials/NCT02081287
NCT02081287CompletedPhase 1

Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

San Diego Veterans Healthcare System1 site in 1 country8 target enrollmentStarted: May 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
8
Locations
1
Primary Endpoint
Depression

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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)

Arms & Interventions

Lamotrigine

Active Comparator

As adjunct to lithium therapy

Intervention: Lamotrigine (Drug)

IP6

Experimental

As adjunct to lithium therapy

Intervention: IP6 (Drug)

Outcomes

Primary Outcomes

Depression

Time Frame: 10 weeks

As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory

Secondary Outcomes

  • Sleep Quality(10 weeks)
  • Mania(10 weeks)
  • Global Function(10 weeks)
  • Side Effect Burden(10 weeks)

Investigators

Sponsor
San Diego Veterans Healthcare System
Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Michael McCarthy

Staff Psychiatrist

San Diego Veterans Healthcare System

Study Sites (1)

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