NCT02081287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

4.2 years

First QC Date

March 5, 2014

Last Update Submit

July 30, 2018

Conditions

Bipolar DisorderManic Depression

Keywords

Bipolar DisorderDepressionInositolInositol HexaphosphatePhytic AcidIP6LithiumLamotrigine

Outcome Measures

Primary Outcomes (1)

  • Depression

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

    10 weeks

Secondary Outcomes (4)

  • Sleep Quality

    10 weeks

  • Global Function

    10 weeks

  • Side Effect Burden

    10 weeks

  • Mania

    10 weeks

Other Outcomes (1)

  • Morning vs Evening Preference

    10 weeks

Study Arms (2)

Lamotrigine

ACTIVE COMPARATOR

As adjunct to lithium therapy

Drug: Lamotrigine

IP6

EXPERIMENTAL

As adjunct to lithium therapy

Drug: IP6

Interventions

IP6DRUG

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

Also known as: Inositol Hexaphosphate, Phytic Acid
IP6
LamotrigineDRUG

Dose up to 200 mg per day over 10 weeks

Also known as: Lamictal
Lamotrigine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

Phytic AcidLamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Inositol PhosphatesInositolSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesSugar PhosphatesTriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael J. McCarthy, MD, PhD

    VA San Diego Healthcare, UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychiatrist

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 7, 2014

Study Start

May 1, 2014

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

US(1)