We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00109577
First Posted: April 29, 2005
Last Update Posted: September 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alberta Innovation and Science
Information provided by (Responsible Party):
Bonnie Kaplan, University of Calgary
Results First Submitted: June 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: MCN36 (nutritional supplement)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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.  

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

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.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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)
First Submitted: April 28, 2005
First Posted: April 29, 2005
Results First Submitted: June 25, 2012
Results First Posted: September 11, 2012
Last Update Posted: September 18, 2012