Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder
Drug: MCN36 (nutritional supplement)
|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|
- 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
- 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 ]
|Study Start Date:||April 2005|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2
Placebo comparator, 6 placebo capsules three times a day
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109577
|United States, California|
|Dr Estelle Goldstein|
|San Diego, California, United States, 92116|
|University of Calgary Faculty of Medicine|
|Calgary, Alberta, Canada, T2N 4N1|
|Principal Investigator:||Bonnie J Kaplan, PhD||University of Calgary|