Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder

NCT00109577 | Terminated Phase 2 Results DMC

• 2 other identifiers: 18229AIS99-03A (01406-005-23)
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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 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.

Conditions

Bipolar Disorder

Keywords

bipolar disorder; mood disorders; manic depression; nutrition

Outcome Measures

Primary Outcomes (1)

• Mood as Evaluated by the Overall Bipolarity Index (Composite of the Hamilton Depression Scale and the Young Mania Rating Scale)

  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

  Baseline to 8 weeks

Secondary Outcomes (3)

• Global Clinical Impressions

  Baseline to 8 weeks

• Outcome Questionnaire --- a Self-report Questionnaire

  Baseline to 8 weeks

• Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)

  Baseline to 8 weeks

Study Arms (2)

2

PLACEBO COMPARATOR

Placebo comparator, 6 placebo capsules three times a day

Drug: Placebo

1

EXPERIMENTAL

nutritional supplement intervention, 6 nutritional supplement capsules three times a day; the nutritional supplement is a 36-ingredient micronutrient supplement (primarily vitamins and minerals) and is referred to as MCN36, because it contains 36 nutrients.

Drug: MCN36 (nutritional supplement)

Interventions

MCN36 (nutritional supplement) DRUG

nutritional supplement

1

Placebo DRUG

nutritional supplement

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Innovation and Science: collaborator

Study Sites (2)

Dr Estelle Goldstein

San Diego, California, 92116, United States

Location

University of Calgary Faculty of Medicine

Calgary, Alberta, T2N 4N1, Canada

Location

Related Publications (6)

• Kaplan BJ, Simpson JS, Ferre RC, Gorman CP, McMullen DM, Crawford SG. Effective mood stabilization with a chelated mineral supplement: an open-label trial in bipolar disorder. J Clin Psychiatry. 2001 Dec;62(12):936-44. doi: 10.4088/jcp.v62n1204.

  PMID: 11780873 BACKGROUND

• Kaplan BJ, Fisher JE, Crawford SG, Field CJ, Kolb B. Improved mood and behavior during treatment with a mineral-vitamin supplement: an open-label case series of children. J Child Adolesc Psychopharmacol. 2004 Spring;14(1):115-22. doi: 10.1089/104454604773840553.

  PMID: 15142398 BACKGROUND

• Kaplan BJ, Crawford SG, Gardner B, Farrelly G. Treatment of mood lability and explosive rage with minerals and vitamins: two case studies in children. J Child Adolesc Psychopharmacol. 2002 Fall;12(3):205-19. doi: 10.1089/104454602760386897.

  PMID: 12427294 BACKGROUND

• Popper CW. Do vitamins or minerals (apart from lithium) have mood-stabilizing effects? J Clin Psychiatry. 2001 Dec;62(12):933-5. doi: 10.4088/jcp.v62n1203. No abstract available.

  PMID: 11780872 BACKGROUND

• Simmons M. Nutritional approach to bipolar disorder. J Clin Psychiatry. 2003 Mar;64(3):338; author reply 338-9. doi: 10.4088/jcp.v64n0317d. No abstract available.

  PMID: 12716280 BACKGROUND

• Kaplan BJ, Crawford SG, Field CJ, Simpson JS. Vitamins, minerals, and mood. Psychol Bull. 2007 Sep;133(5):747-60. doi: 10.1037/0033-2909.133.5.747.

  PMID: 17723028 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Bonnie Kaplan
• Organization: University of Calgary

kaplan@ucalgary.ca

403-955-7363

Study Officials

• Bonnie J Kaplan, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2005
• First Posted: April 29, 2005
• Study Start: April 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 18, 2012
• Results First Posted: September 11, 2012

Record last verified: 2012-09

Locations

US (1); CA (1)