NeuroSpectrum™360: Research and Clinical References

Researchers at the world-renowned Canadian Centre for Behavioural Neuroscience conducted a series of controlled studies with rats fed a micronutrient blend co-formulated by David Hardy to test its effects on brain injuries and brain-related disorders. Neuroscientists removed either the entire frontal lobe or part of the parietal lobe of the brain in treatment animals, and then the neural tissue was regrown with either the standard lab rat diet or with the treatment diet enhanced with the micronutrient formula. Brain recovery was significantly enhanced in the micronutrient-fed rats over those receiving the standard diet. Impressively, on certain cognitive, behavioral, and motor tasks the micronutrient-fed treatment group scored as well as the control rats! Post-mortem analyses revealed that in both surgery and control animals the micronutrient treatment increased cortical thickness and dendritic length, supporting the use of micronutrient formulations for human brain trauma recovery in conjunction with brain rehabilitation therapies.
[Factors influencing frontal cortex development and recovery from early frontal injury. Halliwell C, Comeau W, Gibb R, Frost DO, Kolb B. Developmental Neurorehabilitation. 2009;12(5):269-78.]†

BACKGROUND:
Evaluation of broad-spectrum micronutrient (vitamins and minerals) treatment for childhood ADHD has been limited to open-label studies that highlight beneficial effects across many aspects of psychological functioning.

METHOD:
This is the first fully blinded randomized controlled trial of medication-free children (n = 93) with ADHD (7-12 years) assigned to either micronutrients (n = 47) or placebo (n = 46) in a 1:1 ratio, for 10 weeks. All children received standardized ADHD assessments. Data were collected from clinicians, parents, participants and teachers across a range of measures assessing ADHD symptoms, general functioning and impairment, mood, aggression and emotional regulation.

RESULTS:
Intent-to-treat analyses showed significant between-group differences favouring micronutrient treatment on the Clinical Global Impression-Improvement (ES = 0.46), with 47% of those on micronutrients identified as ‘much’ to ‘very much’ improved versus 28% on placebo. No group differences were identified on clinician, parent and teacher ratings of overall ADHD symptoms (ES ranged 0.03-0.17). However, according to clinicians, 32% of those on micronutrients versus 9% of those on placebo showed a clinically meaningful improvement on inattentive (OR = 4.9; 95% CI: 1.5-16.3), but no group differences on improvement in hyperactive-impulsive symptoms (OR = 1.0; 95% CI: 0.4-2.5). Based on clinician, parent and teacher report, those on micronutrients showed greater improvements in emotional regulation, aggression and general functioning compared to placebo (ES ranged 0.35-0.66). There were two dropouts per group, no group differences in adverse events and no serious adverse events identified. Blinding was successful with guessing no better than chance.

CONCLUSIONS:
Micronutrients improved overall function, reduced impairment and improved inattention, emotional regulation and aggression, but not hyperactive/impulsive symptoms, in this sample of children with ADHD. Although direct benefit for core ADHD symptoms was modest, with mixed findings across raters, the low rate of adverse effects and the benefits reported across multiple areas of functioning indicate micronutrients may be a favourable option for some children, particularly those with both ADHD and emotional dysregulation. Trial registered with the Australian New Zealand Clinical Trials Registry ACTRN12613000896774.
[Vitamin-mineral treatment improves aggression and emotional regulation in children with ADHD: a fully blinded, randomized, placebo-controlled trial. Rucklidge JJ, Eggleston MJF, Johnstone JM, Darling K, Frampton CM. J Child Psychol Psychiatry. 2017 Oct 2.]

[Factors influencing frontal cortex development and recovery from early frontal injury. Halliwell C, Comeau W, Gibb R, Frost DO, Kolb B. Developmental Neurorehabilitation. 2009;12(5):269-78.]†

A micronutrient formulation co-developed by NeuroSpectrum®360 formulator 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 a placebo for 8 weeks. Most of the study participants had at least one psychiatric diagnosis in addition to ADHD, including 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 (p=0.009). Clinical psychologists rated more than twice as many people in the nutrient group than the placebo 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 (p=0.039). 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 compiled safety data from all published and unpublished studies that used a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy which has been widely researched in the mental health field. Biological safety data from six sources, including 144 children and adults, showed no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event information from six studies involving 157 children and adults included reports of minor, transitory headache and nausea. Only one of the studies permitted a direct comparison between tolerability of the micronutrient treatment and medications: children and adults treated with micronutrients showed significantly fewer adverse events and significantly less weight gain compared with those taking medications.
[Systematic review of safety and tolerability of a complex micronutrient formula used in mental health.†
Simpson JS, Crawford SG, Goldstein ET, Field C, Burgess E, Kaplan BJ. BioMed Central Psychiatry. 2011 Apr 18;11:62.]

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.]

A 7.1-magnitude earthquake in Christchurch, New Zealand created a natural experiment for measuring the protective effects of a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy on mood, anxiety and stress. Prior to the earthquake, researchers had assessed mood, anxiety and stress levels in a group of 33 adults diagnosed with attention deficit hyperactivity disorder, and they chose to repeat the same measures after the earthquake. Scores showed that the 16 participants taking micronutrients were more resilient to the effects of the earthquake than the 17 individuals not taking any supplement. This effect was particularly marked for depression scores.
[Post-earthquake psychological functioning in adults with attention-deficit/hyperactivity disorder: positive effects of micronutrients on resilience.†
Rucklidge JJ, Blampied, NM. New Zealand Journal of Psychology. 2011;40(4):51]

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.]

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.]

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.]

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 two medication-free boys with unstable mood and explosive rage who took a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy followed by reversal and re-treatment. The boys’ diagnoses included pervasive developmental disorder with Asperger characteristics, attention deficit hyperactivity disorder, obsessive-compulsive disorder, and autism. Both boys benefited significantly from the micronutrient formula: mood, angry outbursts, delinquent behavior, social and attention problems, and anxious/obsessional symptoms improved when initially treated, returned when they discontinued treatment, and remitted when the micronutrient treatment was reintroduced. During a follow-up of over 2 years, both boys continued to be stable while taking the micronutrient treatment.
[Treatment of mood lability and explosive rage with minerals and vitamins: two case studies in children.
Kaplan BJ, Crawford SG, Gardner B, Farrelly G. Journal of Child and Adolescent Psychopharmacology. 2002 Fall;12(3):205-19.]

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.]

Scientists observed while conducting previous studies that many study participants whose psychiatric symptoms were treated successfully with a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy tended to reduce or eliminate use of alcohol, cigarettes and cannabis on their own. This study details one case in which on-off micronutrient use resulted in off-on cigarette and cannabis smoking as well as off-on psychiatric symptoms. Micronutrients provide the necessary precursors and cofactors for adequate neurotransmitter production and regulation. In this way, micronutrients assist with mood regulation, help reduce anxiety, and directly affect brain reward circuitry, all of which can help individuals to successfully stop drug use.
[Use of micronutrients attenuates cannabis and nicotine abuse as evidenced from a reversal design: a case study.
Harrison R, Rucklidge JJ, Blampied N. Journal of Psychoactive Drugs. 2013 Jun;45(2):168-178.]

The role of good nutrition for resilience in the face of stress is a topic of interest, but difficult to study. A 7.1 earthquake took place in the midst of research on a micronutrient treatment for Attention-Deficit/Hyperactivity Disorder (ADHD), providing a unique opportunity to examine whether individuals with ADHD taking micronutrients demonstrated more emotional resilience post-earthquake than individuals with ADHD not taking micronutrients. Thirty-three adults with ADHD were assessed twice following the earthquake using a measure of depression, anxiety and stress also completed at some point pre-earthquake (baseline). Seventeen were not taking micronutrients at the time of the earthquake (control group), 16 were (micronutrient group). While there were no between-group differences one week post-quake (Time 1), at two weeks post-quake (Time 2), the micronutrient group reported significantly less anxiety and stress than the controls (effect size 0.69). These between group differences could not be explained by other variables, such as pre-earthquake measures of emotions, demographics, psychiatric status, and personal loss or damage following the earthquake. The results suggest micronutrients may increase resilience to ongoing stress and anxiety associated with a highly stressful event in individuals with ADHD and are consistent with controlled studies showing benefit of micronutrients for mental health.
[Micronutrients reduce stress and anxiety following a 7.1 earthquake in adults with Attention-Deficit/Hyperactivity Disorder
Rucklidge JJ, Johnstone J, Harrison R, Boggis A. 2011. Psychiatry Research, 189:281-87.]

Dr. Julia Rucklidge conducted nutrient assays on study participants in her 8 week double-blind RCT using micronutrient treatment for adult ADHD. Using this extensive data set, she performed a post-hoc analysis of the original study in an attempt to determine if blood levels of nutrients in adult ADHD patients could be used to predict whether or not they would respond to micronutrient treatment. The blood markers measured were Vitamin D, Vitamin B12, Folate, Iron, Zinc, Copper, and Ferritin.

[Moderators of treatment response in adults with ADHD treated with a vitamin-mineral supplement
Rucklidge JJ, Johnstone J, Gorman B, Boggis A, Frampton CM. Prog Neuropsychopharmacol Biol Psychiatry. 2014 Apr 3;50:163-71. doi:10.1016/j.pnpbp.2013.12.014. Epub 2013 Dec 26. PubMed PMID: 24374068.]†

In January 2014, The British Journal of Psychiatry published the results of a double-blind controlled trial which provided evidence of efficacy for micronutrients† (vitamins and minerals) in the treatment of ADHD symptoms in adults, with a reassuring safety profile.
As a follow-up to the adult trial, and pilot study for a RCT in childhood ADHD, the Journal of Child and Adolescent Psychopharmacology recently published the results of a study which treated 14 children with Attention-Deficit/Hyperactivity Disorder (ADHD) using micronutrients† instead of medication.
The study demonstrated the clinical benefit, feasibility, and safety of broad-spectrum micronutrients in the treatment of childhood ADHD.
In the recently published study, medication-free children were treated with a micronutrient formula† for eight weeks and then taken off it for four weeks—with the on-off cycle repeating itself over a six-month period.
[Clinically Significant Symptom Reduction in Children with Attention-Deficit/Hyperactivity Disorder Treated with Micronutrients: An Open-Label Reversal Design Study
Gordon HA, Rucklidge JJ, Blampied NM, Johnstone JM. J Child Adolesc Psychopharmacol. 2015 Dec;25(10):783-98. doi: 10.1089/cap.2015.0105. PubMed PMID: 26682999; PubMed Central PMCID: PMC4702182.]

Following a 6.3-magnitude earthquake in Christchurch, New Zealand, researchers randomized 91 earthquake survivors to take one of two vitamin-mineral formulas (Berocca Performance or a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy. Then they measured symptoms of situation-induced depression, anxiety, and stress in these individuals, as well as 25 additional people who took no supplement (a control group). After 4 weeks, 20% of the control group, 43% of the Berocca Performance group, and 74% of the group taking the micronutrients showed significant improvement in depression, anxiety, and stress symptoms. Researchers concluded that this study supports micronutrients as an inexpensive and practical treatment for acute stress following a natural disaster, with a slight advantage to higher doses.

[Shaken but unstirred? Effects of micronutrients on stress and trauma after an earthquake: RCT evidence comparing formulas and doses.
Rucklidge JJ, Andridge R, Gorman B, Blampied N, Gordon H, Boggis A. Human Psychopharmacology. 2012 Sep;27(5):440-54.]

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 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 detail an off-on-off-on trial of an 18-year-old male diagnosed with obsessive-compulsive disorder (OCD) and Asperger’s disordera who took a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy. The young man first underwent cognitive behavioral therapy (CBT) for one year with a modest response. Within a year thereafter, his anxiety became severe again and he began to experience major depression. After 8 weeks of using a vitamin-mineral formulation, his mood stabilized, his anxiety reduced, and his obsessions were in remission. Treatment was then discontinued for 8 weeks, during which time his obsessions, anxiety, and mood worsened. Reintroduction of the micronutrient formula again improved mood, obsession and anxiety symptoms within 8 weeks. After taking the formulation for 6 months longer, he experienced further improvements in mood and anxiety symptoms.
[Successful treatment of OCD with a micronutrient formula following partial response to Cognitive Behavioral Therapy (CBT): a case study.
Rucklidge JJ. Journal of Anxiety Disorders. 2009 Aug;23(6):836-40.]†

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.]†

An 11-year-old boy with a 3-year history of mental illness and psychiatric medication treatment was transitioned to a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy. The boy was diagnosed with multiple psychiatric disorders, including obsessive-compulsive disorder, generalized anxiety disorder, social anxiety disorder, and psychosis—not otherwise specified. The boy’s anxiety, obsessive-compulsive, and psychotic symptoms decreased significantly when he took the vitamin-mineral formulation, and his progress was maintained through a 4-year follow-up. A cost comparison revealed that the boy’s micronutrient treatment cost less than 1% of his former inpatient mental health care.
[Efficacy and cost of micronutrient treatment of childhood psychosis.
Rodway M, Vance A, Watters A, Lee H, Bos E, Kaplan BJ. BMJ Case Reports. 2012 Nov 9;2012.]†

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.]†

Insomnia is a debilitating condition causing psychological distress and frequently comorbid with other mental health conditions. This study examined the effect of 8 weeks of treatment by broad spectrum micronutrients on insomnia using a multiple-baseline-across-participants open-label trial design. Seventeen adults were randomized to 1-, 2-, or 3-week baseline periods (14 completed). Self-report measures were the Consensus Sleep Diary–Morning (CSD-M), the Pittsburgh Insomnia Rating Scale (PIRS), and the Depression, Anxiety, Stress Scale (DASS). Baselines were generally stable. Treatment completers reported reliable and clinically significant change in insomnia severity (PIRS), in depression, stress, and anxiety (DASS), and on at least two aspects of sleep measured by the CDS-M. All completers were treatment-compliant, and side effects were minimal. Nutritional supplementation is shown to be a novel, beneficial treatment for insomnia in adults. Follow-up research using placebo-controlled designs as well as comparisons to cognitive-behavioral and other treatments is recommended.
[Effect of Micronutrients on Insomnia in Adults: A Multiple-Baseline Study
Joanna Lothian, Neville M. Blampied, Julia J. Rucklidge. Clinical Psychological Science. May 23, 2016.doi:10.1177/2167702616631740]†

Researchers compared psychiatric medication and micronutrient treatment approaches in 88 children with autism spectrum disorder. The micronutrient group (taking predominately a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy improved significantly more than the medication group in key ways, including notably reduced irritability, anger, and intensity of self-injurious behaviors. The micronutrient-treated group also had dramatically lower treatment side-effects.
[Micronutrients versus standard medication management in autism: a naturalistic case-control study. Mehl-Madrona L, Leung B, Kennedy C, Paul S, Kaplan BJ. Journal of Child and Adolescent Psychopharmacology. 2010 Apr;20(2):95-103.]†