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Completed

NCT Number: NCT02081287

Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

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.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Depression Manic Depression Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IP6

Drug

IP6 2,000 -3,000 mg per day given orally in two doses

Other names: Inositol Hexaphosphate, Phytic Acid

Lamotrigine

Drug

Dose up to 200 mg per day over 10 weeks

Other names: Lamictal

Primary outcomes

  1. Depression

    Time frame: 10 weeks

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

Secondary outcomes

  1. Sleep Quality

    Time frame: 10 weeks

    As measured by the Pittsburgh Sleep Quality Index

  2. Global Function

    Time frame: 10 weeks

    As measured by the Clinician Global Inventory

  3. Side Effect Burden

    Time frame: 10 weeks

    As measured by standardized inventory

  4. Mania

    Time frame: 10 weeks

    As measured by the Young Mania Scale, and Internal State Scale

Other outcomes

  1. Morning vs Evening Preference

    Time frame: 10 weeks

    As measured by the Basic language morningness scale

Sponsors and collaborators

Lead sponsor

San Diego Veterans Healthcare System

Fed

Collaborators

  • The Depressive and Bipolar Disorder Alternative Treatment Foundation

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2014
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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