Status:
TERMINATED
Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Alberta Innovation and Science
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ran...
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 e...
Eligibility Criteria
Inclusion
- Must meet the criteria for bipolar disorder I or II as defined in DSM-IV-TR based on clinical assessment and confirmed by structured diagnostic interview (SCID-P).
- Must be symptomatic on the Hamilton Depression Scale and the Young Mania Rating Scale
- Must be free of medications or herbal/nutritional supplements with primarily central nervous system activity
- Must be able to eat at least a snack three times per day, so that the capsules will not be ingested on an empty stomach
Exclusion
- Current or lifetime diagnosis of any of the following according to DSM-IV-TR criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Dementia of any type, Amnestic Disorder, unless there is substantive reason to believe the patient was misdiagnosed.
- Alcohol dependence or abuse in the previous six months.
- Dependence or abuse of substances other than alcohol in the previous two years.
- Any Psychotic Disorder due to a General Medical Condition in the previous two years
- Hospitalization for treatment of a mental disorder within the previous 6 months.
- Current use of any other medication or herbal/nutritional supplement with primarily central nervous system activity.
- Neurological disorder involving brain or other central function.
- Severe headaches of any type (including migraine) within the previous 3 months.
- Unstable illnesses either with active significant symptoms or requiring medication changes within the previous 4 months.
- Abnormal laboratory values detected at screening, in particular an ALT or AST greater than 2 times the upper limit of normal, or creatinine greater than 1.75 times the upper limit of normal.
- Uncorrected or unstable hypothyroidism or hyperthyroidism in the previous 12 months.
- Medically diagnosed Irritable Bowel Syndrome, or any other chronic gastrointestinal problem, within the previous 3 years.
- Current or lifetime metabolic disorder or problem, such as phenylketonuria or Wilson's disease.
- A course of treatment with electroconvulsive therapy (ECT) within the previous 12 months, or a lifetime history of four or more courses of ECT.
- Current bacterial, viral, fungal, parasite or other infection.
- Women who are pregnant or breast-feeding; women of childbearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00109577
Start Date
April 1 2005
End Date
March 1 2009
Last Update
September 18 2012
Active Locations (2)
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1
Dr Estelle Goldstein
San Diego, California, United States, 92116
2
University of Calgary Faculty of Medicine
Calgary, Alberta, Canada, T2N 4N1