Bipolar DisorderPhase 1NCT02081287
Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?
A Phase 1 study testing IP6 and Lamotrigine in people with Bipolar Disorder and Manic Depression, run by San Diego Veterans Healthcare System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder, Manic Depression
- What is being tested?
- IP6 and Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 30 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
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.
- Conditions
- Bipolar Disorder, Manic Depression
- Being tested
- IP6, Lamotrigine
- Keywords
- Bipolar Disorder, Depression, Inositol, Inositol Hexaphosphate, Phytic Acid, IP6, Lithium, Lamotrigine
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP6Drug
Also called Inositol Hexaphosphate, Phytic Acid
IP6 2,000 -3,000 mg per day given orally in two doses
LamotrigineDrug
Also called Lamictal
Dose up to 200 mg per day over 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine | Active comparator | As adjunct to lithium therapy Receives: Drug: Lamotrigine |
| IP6 | Experimental | As adjunct to lithium therapy Receives: Drug: IP6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory
Measured: 10 weeks
Secondary outcomes (4)
Sleep Quality
As measured by the Pittsburgh Sleep Quality Index
Measured: 10 weeks
Global Function
As measured by the Clinician Global Inventory
Measured: 10 weeks
Side Effect Burden
As measured by standardized inventory
Measured: 10 weeks
Mania
As measured by the Young Mania Scale, and Internal State Scale
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- The Depressive and Bipolar Disorder Alternative Treatment Foundation
- Responsible party
- Principal investigator, Michael McCarthy, San Diego Veterans Healthcare System
- Investigators
- Michael J. McCarthy, MD, PhD, Principal investigator, VA San Diego Healthcare, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081287
- Sponsor's protocol ID
- DBDAT-2013-MJM
- Status last verified
- Jul 2018
- First submitted
- 5 Mar 2014
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?
- ClinicalTrials.gov ID
- NCT02081287
- Acronym / sponsor ID
- DBDAT-2013-MJM
- Conditions
- Bipolar Disorder, Manic Depression
- Keywords
- Bipolar Disorder, Depression, Inositol, Inositol Hexaphosphate, Phytic Acid, IP6, Lithium, Lamotrigine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- San Diego Veterans Healthcare SystemUS federal agency
- Collaborators
- The Depressive and Bipolar Disorder Alternative Treatment Foundation
- Study start
- May 2014
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine | Active comparator | Drug: LamotrigineAs adjunct to lithium therapy |
| IP6 | Experimental | Drug: IP6As adjunct to lithium therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IP6Also: Inositol Hexaphosphate, Phytic AcidIP6 2,000 -3,000 mg per day given orally in two doses | Drug | IP6 |
| LamotrigineAlso: LamictalDose up to 200 mg per day over 10 weeks | Drug | Lamotrigine |
Primary outcome
Depression
Time frame: 10 weeks
As measured by rater administered Hamilton depression inventory, and Beck Depression Inventory
4 secondary outcomes
Sleep Quality
Time frame: 10 weeks
Global Function
Time frame: 10 weeks
Side Effect Burden
Time frame: 10 weeks
Mania
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J. McCarthy, MD, PhD principal investigator
VA San Diego Healthcare, UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IP6 and Lamotrigine in people with Bipolar Disorder and Manic Depression, run by San Diego Veterans Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.