Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder
NCT ID: NCT00109577
Last Updated: 2012-09-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2005-04-30
2009-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2
Placebo comparator, 6 placebo capsules three times a day
Placebo
nutritional supplement
1
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.
MCN36 (nutritional supplement)
nutritional supplement
Interventions
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MCN36 (nutritional supplement)
nutritional supplement
Placebo
nutritional supplement
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Alberta Innovation and Science
OTHER
University of Calgary
OTHER
Responsible Party
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Bonnie Kaplan
Professor
Principal Investigators
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Bonnie J Kaplan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Dr Estelle Goldstein
San Diego, California, United States
University of Calgary Faculty of Medicine
Calgary, Alberta, Canada
Countries
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References
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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.
Kaplan 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.
Kaplan 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.
Popper 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.
Simmons 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.
Kaplan 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.
Other Identifiers
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AIS99-03A (01406-005-23)
Identifier Type: -
Identifier Source: secondary_id
18229
Identifier Type: -
Identifier Source: org_study_id