Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder

This study has been terminated.
(Unable to recruit large enough sample; large expectancy effects but no adverse events)
Sponsor:
Collaborator:
Alberta Innovation and Science
Information provided by (Responsible Party):
Bonnie Kaplan, University of Calgary
ClinicalTrials.gov Identifier:
NCT00109577
First received: April 28, 2005
Last updated: September 11, 2012
Last verified: September 2012
Results First Received: June 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: MCN36 (nutritional supplement)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo Comparator     Micronutrient Formula  
STARTED     20     20  
COMPLETED     17     17  
NOT COMPLETED     3     3  
Withdrawal by Subject                 3                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Comparator Placebo comparator
Micronutrient Formula nutritional supplement
Total Total of all reporting groups

Baseline Measures
    Placebo Comparator     Micronutrient Formula     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  40  ± 13     35  ± 9     37.5  ± 11  
Gender  
[units: participants]
     
Female     12     11     23  
Male     8     9     17  
Region of Enrollment  
[units: participants]
     
United States     4     3     7  
Canada     16     17     33  



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Global Clinical Impressions   [ Time Frame: Baseline to 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Outcome Questionnaire --- a Self-report Questionnaire   [ Time Frame: Baseline to 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)   [ Time Frame: Baseline to 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Bonnie Kaplan
Organization: University of Calgary
phone: 403-955-7363
e-mail: kaplan@ucalgary.ca


Publications:

Responsible Party: Bonnie Kaplan, University of Calgary
ClinicalTrials.gov Identifier: NCT00109577     History of Changes
Other Study ID Numbers: 18229, AIS99-03A (01406-005-23)
Study First Received: April 28, 2005
Results First Received: June 25, 2012
Last Updated: September 11, 2012
Health Authority: Canada: Health Canada
United States: Institutional Review Board