Trial Outcomes & Findings for Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder (NCT NCT00109577)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Baseline to 8 weeks

Results posted on

2012-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Comparator Placebo comparator capsules	Micronutrient Formula nutritional supplement capsules containing 36-ingredients primarily vitamins and minerals; the supplement is referred to as MCN36, because it contains 36 nutrients.
Overall Study STARTED	20	20
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Comparator Placebo comparator capsules	Micronutrient Formula nutritional supplement capsules containing 36-ingredients primarily vitamins and minerals; the supplement is referred to as MCN36, because it contains 36 nutrients.
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Comparator n=20 Participants Placebo comparator	Micronutrient Formula n=20 Participants nutritional supplement	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	40 years STANDARD_DEVIATION 13 • n=5 Participants	35 years STANDARD_DEVIATION 9 • n=7 Participants	37.5 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Canada	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: All participants were included, since the analysis was intent-to-treat with last observation carried forward

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

Outcome measures

Outcome measures
Measure	Placebo Comparator n=20 Participants Placebo comparator capsules	Micronutrient Formula n=20 Participants nutritional supplement capsules
Mood as Evaluated by the Overall Bipolarity Index (Composite of the Hamilton Depression Scale and the Young Mania Rating Scale)	-21.1 units on a scale Standard Deviation 3.4	-18.9 units on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Outcome measures

Outcome data not reported

Adverse Events

Placebo Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Micronutrient Formula

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bonnie Kaplan

University of Calgary

Phone: 403-955-7363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place