Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder

This study has been terminated.
(Unable to recruit large enough sample; large expectancy effects but no adverse events)
Sponsor:
Collaborator:
Alberta Innovation and Science
Information provided by (Responsible Party):
Bonnie Kaplan, University of Calgary
ClinicalTrials.gov Identifier:
NCT00109577
First received: April 28, 2005
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: MCN36 (nutritional supplement)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Placebo-controlled Phase II Trial of MCN36 in Adults With Bipolar Disorder

Resource links provided by NLM:


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: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Global Clinical Impressions [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Outcome Questionnaire --- a Self-report Questionnaire [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Placebo comparator, 6 placebo capsules three times a day
Drug: Placebo
nutritional supplement
Experimental: 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.
Drug: MCN36 (nutritional supplement)
nutritional supplement

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Bonnie Kaplan, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00109577     History of Changes
Other Study ID Numbers: 18229, AIS99-03A (01406-005-23)
Study First Received: April 28, 2005
Results First Received: June 25, 2012
Last Updated: September 11, 2012
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:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014