Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109577
Status:
TERMINATED
Last Update Posted:
2012-09-18
First Post:
2005-04-28
Brief Title:
Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Randomized Placebo-controlled Phase II Trial of MCN36 in Adults With Bipolar Disorder
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit large enough sample large expectancy effects but no adverse events
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AIS99-03A 01406-005-23 | None | None | None |