ABSTRACT
Objectives: The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (FAs) and inositol alone and in combination for the treatment of pediatric bipolar (BP) spectrum disorder in young children. Methods: Participants were male and female children ages 5-12 meeting DSM-IV diagnostic criteria for a BP spectrum disorder and displaying mixed, manic, or hypomanic symptoms without psychotic features at the time of evaluation. Results: Participants concomitantly taking psychotropic medication were excluded from efficacy analyses. There were significant reductions in YMRS and HDRS mean scores in the inositol and combination treatment groups (all p < 0.05) and in CDRS mean scores in the combination treatment group (p < 0.001), with the largest changes seen in the combination group. Those receiving the combination treatment had the highest rates of antimanic and antidepressant response. The odds ratios for the combination group compared to the omega-3 FAs and inositol groups were clinically meaningful (ORs ≥2) for 50% improvement on the YMRS, normalization of the YMRS (score <12) (vs. inositol group only), 50% improvement on the HDRS, 50% improvement on CDRS (vs. omega-3 FAs group only), and CGI-I Mania, CGI-I MDD, and CGI-I Anxiety scores <2. Conclusion: The antimanic and antidepressant effects of the combination treatment of omega-3 FAs and inositol were consistently superior to either treatment used alone. This combination may offer a safe and effective alternative or augmenting treatment for youth with BP spectrum disorder, but more work is needed to confirm the statistical significance of this finding.
Subject(s)
Antipsychotic Agents , Bipolar Disorder , Fatty Acids, Omega-3 , Adolescent , Male , Child , Humans , Female , Child, Preschool , Bipolar Disorder/drug therapy , Bipolar Disorder/diagnosis , Antimanic Agents , Antipsychotic Agents/therapeutic use , Inositol/pharmacology , Inositol/therapeutic use , Psychiatric Status Rating Scales , Double-Blind Method , Antidepressive Agents/therapeutic use , Fatty Acids, Omega-3/pharmacology , Fatty Acids, Omega-3/therapeutic use , Mania , Treatment OutcomeABSTRACT
Objective: ADHD affects 11% of children in the United States and is associated with significant levels of anxiety. Although the literature supports mindfulness-based interventions as a promising strategy for managing anxiety, it falls short in the feasibility of digital mindfulness interventions. Method: This study investigated the usefulness of the pediatric version of Headspace, a digital mindfulness program, for reducing stress in 18 children with ADHD. We conducted a 4-week pilot study to evaluate the Headspace digital mindfulness application for children ages 6 to 12 with ADHD. Parents completed the Beck Anxiety Inventory and the Children's Sleep Habits Questionnaire at baseline and endpoint. Results: Participants had an average age of 9.2 years and were 78% male. The Headspace intervention significantly reduced anxiety and sleep problems in children with ADHD. Conclusion: Children with ADHD and comorbid anxiety and/or sleep problems could benefit from a digitally based meditation application. (J. of Att. Dis. XXXX; XX(X) XX-XX).
Subject(s)
Attention Deficit Disorder with Hyperactivity , Meditation , Mindfulness , Sleep Wake Disorders , Anxiety/therapy , Attention Deficit Disorder with Hyperactivity/complications , Attention Deficit Disorder with Hyperactivity/therapy , Child , Female , Humans , Male , Pilot Projects , Sleep Wake Disorders/therapyABSTRACT
Objective: Attention-deficit/hyperactivity disorder (ADHD) is estimated to affect up to 5% of adults worldwide. Preclinical work demonstrates that L-Threonic Acid Magnesium Salt (LTAMS) administration is associated with neurobiological and neurofunctional effects that could offer clinical benefits in ADHD treatment.Methods: Participants were 15 adults with ADHD of moderate severity. Subjects received up to 12 weeks of open-label LTAMS administered as MMFS302 and MMFS202. The study was approved by the Institutional Review Board and posted on ClinicalTrails.Gov (NCT02558790).Results: 47% of subjects met our criteria of response attaining a CGI-Improvement score ≤2 and AISRS total reduction ≥25%. Significant improvement was seen in the AISRS, CGI-I, and the shifting subscale of the BRIEF. Changes in IQ and WASI-II performance were favorable and significant in the study population.Conclusion: LTAMS supplementation was found to be effective and well tolerated. Nearly half of participants met our definition of ADHD symptom clinical response. These results support the need to further evaluate this compound in larger samples under double-blind conditions.