Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder
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ClinicalTrials.gov Identifier: NCT00109577 |
Recruitment Status :
Terminated
(Unable to recruit large enough sample; large expectancy effects but no adverse events)
First Posted : April 29, 2005
Results First Posted : September 11, 2012
Last Update Posted : September 18, 2012
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Condition or disease | Intervention/treatment | Phase |
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Bipolar Disorder | Drug: MCN36 (nutritional supplement) Drug: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Placebo-controlled Phase II Trial of MCN36 in Adults With Bipolar Disorder |
Study Start Date : | April 2005 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 2
Placebo comparator, 6 placebo capsules three times a day
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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.
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Drug: MCN36 (nutritional supplement)
nutritional supplement |
- 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
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109577
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 |
Principal Investigator: | Bonnie J Kaplan, PhD | University of Calgary |
Responsible Party: | Bonnie Kaplan, Professor, University of Calgary |
ClinicalTrials.gov Identifier: | NCT00109577 |
Other Study ID Numbers: |
18229 AIS99-03A (01406-005-23) |
First Posted: | April 29, 2005 Key Record Dates |
Results First Posted: | September 11, 2012 |
Last Update Posted: | September 18, 2012 |
Last Verified: | September 2012 |
bipolar disorder mood disorders manic depression nutrition |
Disease Bipolar Disorder Pathologic Processes Bipolar and Related Disorders Mental Disorders |