Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: MCN36 (nutritional supplement); Placebo
Intervention description: nutritional supplement; nutritional supplement
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bipolar disorder; mood disorders; manic depression; nutrition

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.