Bipolar DisorderPhase 2NCT00109577
Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder
A Phase 2 study testing MCN36 (nutritional supplement) in people with Bipolar Disorder, run by University of Calgary at 2 sites in 2 countries.
Trial summary
The purpose of the trial was to determine whether a 36-ingredient micronutrient supplement (primarily vitamins and minerals) is beneficial for the treatment of bipolar disorder, when studied under randomized and fully blinded conditions and compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- MCN36 (nutritional supplement)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2005to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must meet the criteria for bipolar disorder I or II as defined in DSM-IV-TR based on clinical assessment and confirmed by structured diagnostic interview (SCID-P).
- Must be symptomatic on the Hamilton Depression Scale and the Young Mania Rating Scale
- Must be free of medications or herbal/nutritional supplements with primarily central nervous system activity
- Must be able to eat at least a snack three times per day, so that the capsules will not be ingested on an empty stomach
Who cannot join
- Current or lifetime diagnosis of any of the following according to DSM-IV-TR criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Dementia of any type, Amnestic Disorder, unless there is substantive reason to believe the patient was misdiagnosed.
- Alcohol dependence or abuse in the previous six months.
- Dependence or abuse of substances other than alcohol in the previous two years.
- Any Psychotic Disorder due to a General Medical Condition in the previous two years
- Hospitalization for treatment of a mental disorder within the previous 6 months.
- Current use of any other medication or herbal/nutritional supplement with primarily central nervous system activity.
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- Neurological disorder involving brain or other central function.
- Severe headaches of any type (including migraine) within the previous 3 months.
- Unstable illnesses either with active significant symptoms or requiring medication changes within the previous 4 months.
- Abnormal laboratory values detected at screening, in particular an ALT or AST greater than 2 times the upper limit of normal, or creatinine greater than 1.75 times the upper limit of normal.
- Uncorrected or unstable hypothyroidism or hyperthyroidism in the previous 12 months.
- Medically diagnosed Irritable Bowel Syndrome, or any other chronic gastrointestinal problem, within the previous 3 years.
- Current or lifetime metabolic disorder or problem, such as phenylketonuria or Wilson's disease.
- A course of treatment with electroconvulsive therapy (ECT) within the previous 12 months, or a lifetime history of four or more courses of ECT.
- Current bacterial, viral, fungal, parasite or other infection.
- Women who are pregnant or breast-feeding; women of childbearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
University of Calgary Faculty of Medicine
Calgary, Alberta, T2N 4N1
About this study
Official title: Randomized Placebo-controlled Phase II Trial of MCN36 in Adults With Bipolar Disorder
The purpose of the trial was to determine whether a 36-ingredient micronutrient supplement (primarily vitamins and minerals) is beneficial for the treatment of bipolar disorder, when studied under randomized and fully blinded conditions and compared to a placebo. The supplement is referred to as MCN36, because it contains 36 nutrients. Based on the preliminary research on this supplement, it is hypothesized that patients who take MCN36 for 8 weeks will experience improved mood stability relative to those who take the placebo. All participants must live EITHER in the vicinity of Calgary, Alberta, Canada, OR in the area of San Diego, California.
Read the detailed description
This RCT (randomized clinical trial) compared MCN36 to placebo in patients randomized to receive one or the other for 8 weeks. Close medical supervision was provided with weekly appointments. At the end of the 8 weeks, all participants were offered the opportunity of entering an 8-week open-label extension.
The efficacy objective of this study was to assess the efficacy of MCN36 compared with placebo in otherwise medication-free adults with bipolar disorder I and II, in improving overall symptomatology at the end of 8 weeks of therapy as assessed under randomized and fully blinded conditions
- as measured by the clinician using the Overall Bipolarity Index (OBI) (primary outcome measure).
- as measured by the clinician using the Clinical Global Impressions for Bipolar Disorder (CGI-BP) for Severity.
- as measured by self-report recorded on the Outcome Questionnaire (OQ).
- in terms of rate of response, with response defined as a reduction of 50% or more in either the depression or the mood elevation component of the OBI.
- in terms of functional states and health-related quality of life as measured by The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36).
The safety-related objective was to assess the safety of MCN36 compared with placebo in terms of
- laboratory analyses
- treatment-emergent adverse events, which will be solicited at each appointment using the Adverse Event Log.
Participants had two appointments for screening and confirming suitability for the trial. Between those two appointments, they provided a blood sample, and met with a research nurse. They also kept a 7-day food record of their food intake prior to the second appointment. If suitability was confirmed at the second visit, they entered the randomized phase.
- Conditions
- Bipolar Disorder
- Being tested
- MCN36 (nutritional supplement), Placebo
- Keywords
- bipolar disorder, mood disorders, manic depression, nutrition
- Medical subject headings
- Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCN36 (nutritional supplement)Drug
nutritional supplement
PlaceboDrug
nutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Placebo comparator, 6 placebo capsules three times a day Receives: Drug: Placebo |
| 1 | Experimental | nutritional supplement intervention, 6 nutritional supplement capsules three times a day; the nutritional supplement is a 36-ingredient micronutrient supplement (primarily vitamins and minerals) and is referred to as MCN36, because it contains 36 nutrients. Receives: Drug: MCN36 (nutritional supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood as Evaluated by the Overall Bipolarity Index (Composite of the Hamilton Depression Scale and the Young Mania Rating Scale)
Change in mood from baseline to final visit, as evaluated by the Overall Bipolarity Index (composite of the Hamilton Depression Scale and the Young Mania Rating Scale); minimum possible score is 0 and maximum possible score is 103; higher scores mean worse symptomatology
Measured: Baseline to 8 weeks
Secondary outcomes (3)
Global Clinical Impressions
Measured: Baseline to 8 weeks
Outcome Questionnaire --- a Self-report Questionnaire
Measured: Baseline to 8 weeks
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Unable to recruit large enough sample; large expectancy effects but no adverse events
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovation and Science
- Responsible party
- Principal investigator, Bonnie Kaplan, University of Calgary
- Investigators
- Bonnie J Kaplan, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109577
- Sponsor's protocol ID
- 18229
- Other IDs
- AIS99-03A (01406-005-23)
- Status last verified
- Sep 2012
- First submitted
- 28 Apr 2005
- Last updated
- 18 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kaplan BJ, Simpson JS, Ferre RC, Gorman CP, McMullen DM, Crawford SG. Effective mood stabilization with a chelated mineral supplement: an open-label trial in bipolar disorder. J Clin Psychiatry. 2001 Dec;62(12):936-44. doi: 10.4088/jcp.v62n1204.
PubMed 11780873Kaplan BJ, Fisher JE, Crawford SG, Field CJ, Kolb B. Improved mood and behavior during treatment with a mineral-vitamin supplement: an open-label case series of children. J Child Adolesc Psychopharmacol. 2004 Spring;14(1):115-22. doi: 10.1089/104454604773840553.
PubMed 15142398Kaplan BJ, Crawford SG, Gardner B, Farrelly G. Treatment of mood lability and explosive rage with minerals and vitamins: two case studies in children. J Child Adolesc Psychopharmacol. 2002 Fall;12(3):205-19. doi: 10.1089/104454602760386897.
PubMed 12427294Popper CW. Do vitamins or minerals (apart from lithium) have mood-stabilizing effects? J Clin Psychiatry. 2001 Dec;62(12):933-5. doi: 10.4088/jcp.v62n1203. No abstract available.
PubMed 11780872Simmons M. Nutritional approach to bipolar disorder. J Clin Psychiatry. 2003 Mar;64(3):338; author reply 338-9. doi: 10.4088/jcp.v64n0317d. No abstract available.
PubMed 12716280Kaplan BJ, Crawford SG, Field CJ, Simpson JS. Vitamins, minerals, and mood. Psychol Bull. 2007 Sep;133(5):747-60. doi: 10.1037/0033-2909.133.5.747.
PubMed 17723028
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Phase II Trial of MCN36 in Adults With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00109577
- Acronym / sponsor ID
- 18229
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, mood disorders, manic depression, nutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit large enough sample; large expectancy effects but no adverse events
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Innovation and Science
- Study start
- Apr 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Apr 2005 (estimated)
- Results
- Posted 11 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial was to determine whether a 36-ingredient micronutrient supplement (primarily vitamins and minerals) is beneficial for the treatment of bipolar disorder, when studied under randomized and fully blinded conditions and compared to a placebo. The supplement is referred to as MCN36, because it contains 36 nutrients. Based on the preliminary research on this supplement, it is hypothesized that patients who take MCN36 for 8 weeks will experience improved mood stability relative to those who take the placebo. All participants must live EITHER in the vicinity of Calgary, Alberta, Canada, OR in the area of San Diego, California.
Detailed description
This RCT (randomized clinical trial) compared MCN36 to placebo in patients randomized to receive one or the other for 8 weeks. Close medical supervision was provided with weekly appointments. At the end of the 8 weeks, all participants were offered the opportunity of entering an 8-week open-label extension.
The efficacy objective of this study was to assess the efficacy of MCN36 compared with placebo in otherwise medication-free adults with bipolar disorder I and II, in improving overall symptomatology at the end of 8 weeks of therapy as assessed under randomized and fully blinded conditions
- as measured by the clinician using the Overall Bipolarity Index (OBI) (primary outcome measure).
- as measured by the clinician using the Clinical Global Impressions for Bipolar Disorder (CGI-BP) for Severity.
- as measured by self-report recorded on the Outcome Questionnaire (OQ).
- in terms of rate of response, with response defined as a reduction of 50% or more in either the depression or the mood elevation component of the OBI.
- in terms of functional states and health-related quality of life as measured by The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36).
The safety-related objective was to assess the safety of MCN36 compared with placebo in terms of
- laboratory analyses
- treatment-emergent adverse events, which will be solicited at each appointment using the Adverse Event Log.
Participants had two appointments for screening and confirming suitability for the trial. Between those two appointments, they provided a blood sample, and met with a research nurse. They also kept a 7-day food record of their food intake prior to the second appointment. If suitability was confirmed at the second visit, they entered the randomized phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: PlaceboPlacebo comparator, 6 placebo capsules three times a day |
| 1 | Experimental | Drug: MCN36 (nutritional supplement)nutritional supplement intervention, 6 nutritional supplement capsules three times a day; the nutritional supplement is a 36-ingredient micronutrient supplement (primarily vitamins and minerals) and is referred to as MCN36, because it contains 36 nutrients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must meet the criteria for bipolar disorder I or II as defined in DSM-IV-TR based on clinical assessment and confirmed by structured diagnostic interview (SCID-P).
- Must be symptomatic on the Hamilton Depression Scale and the Young Mania Rating Scale
- Must be free of medications or herbal/nutritional supplements with primarily central nervous system activity
- Must be able to eat at least a snack three times per day, so that the capsules will not be ingested on an empty stomach
Key exclusion criteria (16 listed)
- Current or lifetime diagnosis of any of the following according to DSM-IV-TR criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Dementia of any type, Amnestic Disorder, unless there is substantive reason to believe the patient was misdiagnosed.
- Alcohol dependence or abuse in the previous six months.
- Dependence or abuse of substances other than alcohol in the previous two years.
- Any Psychotic Disorder due to a General Medical Condition in the previous two years
- Hospitalization for treatment of a mental disorder within the previous 6 months.
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 |
|---|---|---|
| MCN36 (nutritional supplement)nutritional supplement | Drug | 1 |
| Placebonutritional supplement | Drug | 2 |
Primary outcome
Mood as Evaluated by the Overall Bipolarity Index (Composite of the Hamilton Depression Scale and the Young Mania Rating Scale)
Time frame: Baseline to 8 weeks
Change in mood from baseline to final visit, as evaluated by the Overall Bipolarity Index (composite of the Hamilton Depression Scale and the Young Mania Rating Scale); minimum possible score is 0 and maximum possible score is 103; higher scores mean worse symptomatology
3 secondary outcomes
Global Clinical Impressions
Time frame: Baseline to 8 weeks
Outcome Questionnaire --- a Self-report Questionnaire
Time frame: Baseline to 8 weeks
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11780873Kaplan BJ, Simpson JS, Ferre RC, Gorman CP, McMullen DM, Crawford SG. Effective mood stabilization with a chelated mineral supplement: an open-label trial in bipolar disorder. J Clin Psychiatry. 2001 Dec;62(12):936-44. doi: 10.4088/jcp.v62n1204.
- Background: PubMed 15142398Kaplan BJ, Fisher JE, Crawford SG, Field CJ, Kolb B. Improved mood and behavior during treatment with a mineral-vitamin supplement: an open-label case series of children. J Child Adolesc Psychopharmacol. 2004 Spring;14(1):115-22. doi: 10.1089/104454604773840553.
- Background: PubMed 12427294Kaplan BJ, Crawford SG, Gardner B, Farrelly G. Treatment of mood lability and explosive rage with minerals and vitamins: two case studies in children. J Child Adolesc Psychopharmacol. 2002 Fall;12(3):205-19. doi: 10.1089/104454602760386897.
- Background: PubMed 11780872Popper CW. Do vitamins or minerals (apart from lithium) have mood-stabilizing effects? J Clin Psychiatry. 2001 Dec;62(12):933-5. doi: 10.4088/jcp.v62n1203. No abstract available.
- Background: PubMed 12716280Simmons M. Nutritional approach to bipolar disorder. J Clin Psychiatry. 2003 Mar;64(3):338; author reply 338-9. doi: 10.4088/jcp.v64n0317d. No abstract available.
- Background: PubMed 17723028Kaplan BJ, Crawford SG, Field CJ, Simpson JS. Vitamins, minerals, and mood. Psychol Bull. 2007 Sep;133(5):747-60. doi: 10.1037/0033-2909.133.5.747.
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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.
Bonnie J Kaplan, PhD principal investigator
University of Calgary
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MCN36 (nutritional supplement) in people with Bipolar Disorder, run by University of Calgary at 2 sites in 2 countries.
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 16 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: stopped early, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mood as Evaluated by the Overall Bipolarity Index (Composite of the Hamilton Depression Scale and the Young Mania Rating Scale) (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00109577, which also lists 6 linked publications.
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 18 Sep 2012.