Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder - Full Text View

Sponsor:	University of Calgary
Collaborator:	Alberta Innovation and Science
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00109577

Purpose

The purpose of the trial is 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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: MCN36 (nutritional supplement)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Placebo-Controlled Phase II Trial of MCN36 in Adults With Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression Dietary Supplements

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Mood as evaluated by the Overall Bipolarity Index (composite of the Hamilton Depression Scale and the Young Mania Rating Scale) [ Time Frame: 8 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global Clinical Impressions [ Time Frame: 8 wks ] [ Designated as safety issue: No ]
Outcome Questionnaire --- a self-report questionnaire [ Time Frame: 8 wks ] [ Designated as safety issue: No ]
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) [ Time Frame: 8 wks ] [ Designated as safety issue: No ]

Enrollment:	34
Study Start Date:	April 2005
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Placebo comparator	Drug: MCN36 (nutritional supplement) nutritional supplement
1: Experimental nutritional supplement	Drug: MCN36 (nutritional supplement) nutritional supplement

Detailed Description:

This RCT (randomized clinical trial) will compare MCN36 to placebo in patients randomized to receive one or the other for 8 weeks. Close medical supervision will be provided with weekly appointments. At the end of the 8 weeks, all participants will be offered the opportunity of entering an 8-week open-label extension.

The efficacy objective of this study is 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 is 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 will have two appointments for screening and confirming suitability for the trial. Between those two appointments, they will provide a blood sample, and will meet with a research nurse. They will also keep a 7-day food record of their food intake prior to the second appointment. If suitability is confirmed at the second visit, they will enter the randomized phase.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109577

Locations

United States, California
Dr Estelle Goldstein
San Diego, California, United States, 92116
Canada, Alberta
University of Calgary Faculty of Medicine
Calgary, Alberta, Canada, T2N 4N1

Sponsors and Collaborators

University of Calgary

Alberta Innovation and Science

Investigators

Principal Investigator:

Bonnie J Kaplan, PhD

University of Calgary

More Information

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.

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.

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.

Popper CW. Do vitamins or minerals (apart from lithium) have mood-stabilizing effects? J Clin Psychiatry. 2001 Dec;62(12):933-5. No abstract available.

Simmons M. Nutritional approach to bipolar disorder. J Clin Psychiatry. 2003 Mar;64(3):338; author reply 338-9. No abstract available.

Kaplan BJ, Crawford SG, Field CJ, Simpson JS. Vitamins, minerals, and mood. Psychol Bull. 2007 Sep;133(5):747-60. Review.

Responsible Party:	University of Calgary ( Bonnie J. Kaplan, PhD )
Study ID Numbers:	18229, AIS99-03A (01406-005-23)
Study First Received:	April 28, 2005
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00109577 History of Changes
Health Authority:	Canada: Health Canada; United States: Institutional Review Board

Keywords provided by University of Calgary:

bipolar disorder
mood disorders
manic depression
nutrition

Additional relevant MeSH terms:

Affective Disorders, Psychotic
Pathologic Processes
Disease

Mental Disorders
Bipolar Disorder
Mood Disorders

ClinicalTrials.gov processed this record on November 05, 2009