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NCT00109577 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder
A Phase 2 study, sponsored by University of Calgary.
- Terminated
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00109577: Clinical Trial Phase 2 study, sponsored by University of Calgary.
NCT00109577 is a Phase 2 study that was terminated before completion, run by University of Calgary. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00109577, a Phase 2 study, was terminated before completion, sponsored by University of Calgary.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG MCN36 (nutritional supplement)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-04 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
Why NCT00109577 stopped before completion
NCT00109577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00109577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00109577 about?
NCT00109577 is a clinical study titled "Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder". 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 MCN...
What is the current status of trial NCT00109577?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2005-04. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00109577?
The interventions under investigation include: Placebo (DRUG), MCN36 (nutritional supplement) (DRUG).
Who is sponsoring clinical trial NCT00109577?
This trial is sponsored by University of Calgary, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00109577's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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