A micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy, showed “statistically robust improvements” in the first-ever double-blind study to test the effectiveness and safety of a multivitamin-mineral treatment for adult ADHD. Researchers from the University of Canterbury and the University of Otago, New Zealand, randomized 80 adults diagnosed with ADHD to take either the micronutrient formulation or identical-looking placebo pills for 8 weeks. Most of the study participants had at least one psychiatric diagnosis in addition to ADHD. Additional diagnoses included multiple anxiety disorders, major depressive disorder, dysthymia, bipolar disorder, reading disability, and alcohol/substance misuse or dependence. The nutrient group reported more than double the improvement in attention, hyperactivity, and impulsivity symptoms, compared with the placebo group. Clinical psychologists rated more than twice as many people in the nutrient group ‘very much’ or ‘much’ improved in overall symptoms. They also rated moderate and severely depressed participants in the nutrient group as having nearly double the improvement in depression symptoms. Researchers found that the micronutrients were completely safe; there were no differences in side effects between the two groups.
Vitamin–mineral treatment of attention-deficit hyperactivity disorder in adults: double-blind randomised placebo-controlled trial.
Rucklidge JJ, Frampton CMA, Gorman B, Boggis A. The British Journal of Psychiatry. 2014 Feb;204(2): doi: 10.1192/bjp.bp.113.132126 [Epub ahead of print]
Scientists analyzed data from 358 adults with a diagnosis of bipolar disorder who took a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy for 6 months or more. The adults’ overall symptom severity was 41% lower than baseline after 3 months, and 45% lower after 6 months. In addition, at 6 months, 53% of adults experienced greater than 50% improvement in symptoms, with 32% of adults experiencing greater than 75% improvement in symptoms. Symptom improvements at 6 months suggested that benefits of micronutrient treatment were not attributable to placebo or expectancy effects. Of those taking psychiatric medications, nearly half were able to discontinue them over a 6-month period. The remainder reduced their medication usage by 54% during the same time period. Adults who gradually eliminated their medications and took full recommended levels of the vitamin-mineral formulation experienced the greatest improvements in symptoms.
Database analysis of adults with bipolar disorder consuming a micronutrient formula.
Gately D, Kaplan BJ. Clinical Medicine Insights: Psychiatry. 2009 Apr;4:3-16.
Scientists analyzed data from 120 children with pediatric bipolar disorder who were treated with a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy for at least 6 months. 24% of these children also had a diagnosis of attention deficit hyperactivity disorder (ADHD). Their results were compared with an additional 41 children who were diagnosed with ADHD alone. Children with a bipolar diagnosis showed a 59% decline in symptoms, whereas children with ADHD showed a 40% decrease in symptoms. The duration of symptom reduction suggests that benefits of micronutrient treatment were not attributable to placebo or expectancy effects. Of those taking psychiatric medications, more than half were able to completely discontinue them over a 6-month period. Medication use by the remainder of children was reduced by 74% during the same time period.
Database analysis of children and adolescents with bipolar disorder consuming a micronutrient formula.
Rucklidge JJ, Gately D, Kaplan BJ. BioMed Central Psychiatry. 2010 Sep 28;10:74.
After observing a 10-year-old boy's dramatic response to a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy, Dr. Charles Popper, a psychiatrist and psycho-pharmacologist at Harvard Medical School, treated 22 additional bipolar disorder-diagnosed patients in his private practice (10 adults, 9 adolescents, and 3 preadolescents) with the micronutrients. Nineteen of the 22 patients (86%) showed a positive response to micronutrient treatment. Of the 15 patients being treated with medications when they began the nutritional supplement, 11 patients remained stable during a follow-up period of 6 to 9 months without psychiatric medications.
Do vitamins or minerals (apart from lithium) have mood-stabilizing effects?
Popper CW. The Journal of Clinical Psychiatry. 2001 Dec;62(12):933-5.
Dr. Miles Simmons, a psychiatrist in private practice, followed nineteen patients diagnosed with bipolar I or bipolar II disorder for an average of 13 months while they took a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy. Sixteen of the 19 patients (84%) showed significant clinical improvement. Thirteen of 16 medicated patients were able to completely discontinue psychiatric medications over 3 to 10 weeks and maintain stability over an average follow-up period of 13 months.
Nutritional approach to bipolar disorder.
Simmons M. The Journal of Clinical Psychiatry. 2003 Mar;64(3):338; author reply 338-9.
Researchers documented the impact of a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy in the treatment of 14 medication-free adults with attention deficit hyperactivity disorder. The adults’ additional psychiatric diagnoses included major depressive disorder, bipolar disorder II, generalized anxiety disorder, social phobia, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder with agoraphobia, and psychotic disorder not otherwise specified. During 8 weeks of micronutrient treatment, mood and hyperactivity/impulsivity symptoms normalized. Researchers also noted significant improvements on measures of anxiety, attention, stress, and quality of life. In follow-up, those who continued to take the micronutrients for 2-6 months experienced sustained or improved symptom relief.
Effect of micronutrients on behavior and mood in adults with ADHD: evidence from an 8-week open label trial with natural extension.
Rucklidge J, Taylor M, Whitehead K. Journal of Attention Disorders. 2011 Jan;15(1):79-91.
Researchers treated 11 adults diagnosed with various types of bipolar disorder for an average of 44 weeks with a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy. The adults’ additional diagnoses included attention deficit hyperactivity disorder, dysthymic disorder, and obsessive-compulsive disorder. The adults experienced a 55% reduction in depression symptoms, a 60% reduction in mania symptoms, and a 66% reduction in general psychiatric symptoms. Their psychiatric medication use decreased by more than 50%. The only reported side effect, nausea, was infrequent, minor, and transitory.
Effective mood stabilization with a chelated mineral supplement: an open-label trial in bipolar disorder.
Kaplan BJ, Simpson JS, Ferre RC, Gorman CP, McMullen DM, Crawford SG. The Journal of Clinical Psychiatry. 2001 Dec;62(12):936-44.
Researchers treated nine unselected children with mood and behavioral problems with a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy. The children’s psychiatric diagnoses included attention deficit hyperactivity disorder, bipolar disorder, depression, oppositional defiant disorder, obsessive-compulsive disorder, generalized anxiety disorder, Asperger syndrome, and Prader-Willi syndrome. After a minimum of 8 weeks of micronutrient treatment, the children’s behavior improved significantly in the following areas: anxious and depressed mood, thought problems, interpersonal relationship problems, attention problems, social problems, withdrawn behavior, disruptive behavior, delinquent behavior, aggressive behavior, and self-harm behavior.
Improved mood and behavior during treatment with a mineral-vitamin supplement: an open-label case series of children.
Kaplan BJ, Fisher JE, Crawford SG, Field CJ, Kolb B. Journal of Child and Adolescent Psychopharmacology. 2004 Spring;14(1):115-22.
Researchers documented the effects of a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy on psychiatric and neurocognitive functioning in a naturalistic off-on-off-on design. A 21-year old female with bipolar II disorder, attention deficit hyperactivity disorder (ADHD), social anxiety, and panic disorder began taking a vitamin-mineral formulation following a documented 8-year history of ongoing psychiatric symptoms that were not well managed by medications. After 8 weeks on the formula, she showed significant improvements in mood, anxiety, and hyperactivity/impulsivity. She then chose to come off the formula. After 8 weeks, her depression scores returned to pre-treatment levels, and anxiety and ADHD symptoms worsened dramatically. When the formula was reintroduced, all psychiatric symptoms showed gradual improvements. After one year, she was in remission of all mental illness diagnoses. Her neurocognitive changes mirrored behavioral changes, showing improved processing speed, variability in response, and verbal memory.
Successful treatment of bipolar disorder II and ADHD with a micronutrient formula: a case study.
Rucklidge JJ, Harrison R. CNS Spectrums. 2010 May;15(5):289-95.
Researchers describe a 12-year-old boy who was diagnosed at age 6 with bipolar disorder. His diagnosis evolved to include psychotic features, generalized anxiety disorder and obsessive-compulsive disorder. Although he was treated with psychiatric medications for 6 years, he continued to experience many debilitating mood, anxiety, and obsessive-compulsive symptoms. During treatment with a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy, the boy’s global functioning notably improved. He began interacting more appropriately with peers, remained calm and playful throughout most of the day, slept throughout the night, remained focused and efficient while completing schoolwork, and experienced decreased compulsions. Eventually, his hallucinations also ceased and all diagnoses fully remitted. His symptoms remained stable during a 14-month follow-up period.
Multinutrient supplement as treatment: literature review and case report of a 12-year-old boy with bipolar disorder.
Frazier EA, Fristad MA, Arnold LE. Journal of Child and Adolescent Psychopharmacology. 2009 Aug;19(4):453-60.
Researchers investigated the therapeutic effects of a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy in 7 children with bipolar disorder. The children’s additional psychiatric diagnoses included attention deficit hyperactivity disorder, oppositional defiant disorder, major depressive disorder, generalized anxiety disorder, conduct disorder, and obsessive-compulsive disorder. The children experienced a 37% decrease in depression scores and a 45% decrease in mania scores over 8 weeks. Side effects were minor and transient—mostly temporary gastric discomfort.
Feasibility of a nutritional supplement as treatment for pediatric bipolar spectrum disorders.
Frazier EA, Fristad MA, Arnold LE. Journal of Alternative and Complementary Medicine. 2012 Jul;18(7):678-85.
Researchers studied the impact of a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy on neurocognitive functioning in 14 adults with attention deficit hyperactivity disorder (ADHD) and severe mood dysregulation over an 8-week period. Significant improvement was observed in the ADHD-micronutrient group, but not the control group, across a range of verbal abilities, including verbal learning, verbal cognitive flexibility and fluency, and verbal inhibition. These neurocognitive improvements were large and consistent with improved psychiatric functioning.
Can micronutrients improve neurocognitive functioning in adults with ADHD and severe mood dysregulation? A pilot study.
Rucklidge JJ, Harrison R, Johnstone J. Journal of Alternative and Complementary Medicine. 2011 Dec;17(12):1125-31.
†The micronutrient formulation studied was a pre-2013 version of Truehope EMPowerplus which was co-formulated by David Hardy and Anthony Stephan. Truehope EMPowerplus is a registered trademark of The Synergy Group of Canada Inc., which was co-founded by David Hardy and Anthony Stephan in 1999. David Hardy officially resigned as a shareholder of The Synergy Group of Canada Inc. and director of Truehope Nutritional Support Ltd. in 2013 to focus his efforts exclusively on Hardy Nutritionals®.