Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title: Randomized Placebo-controlled Phase II Trial of MCN36 in Adults With Bipolar Disorder

Status Terminated

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

• NCT number: NCT00109577
• Study type: Interventional
• Source: University of Calgary
• Status: Terminated
• Phase: Phase 2
• Start date: April 2005
• Completion date: March 2009