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A double-blind, placebo-controlled trial of ?-3 fatty acids in Tourette's disorder.

ABSTRACT: Clinical observations have suggested therapeutic effects for ?-3 fatty acids (O3FA) in Tourette's disorder (TD), but no randomized, controlled trials have been reported. In a placebo-controlled trial, we examined the efficacy of O3FA in children and adolescents with TD.Thirty-three children and adolescents (ages 6-18) with TD were randomly assigned, double-blind, to O3FA or placebo for 20 weeks. O3FA consisted of combined eicosapentaenoic acid and docosahexaenoic acid. Placebo was olive oil. Groups were compared by using (1) intent-to-treat design, with the last-observation-carried-forward controlling for baseline measures and attention-deficit/hyperactivity disorder via (a) logistic regression, comparing percentage of responders on the primary Yale Global Tic Severity Scale (YGTSS)-Tic and secondary (YGTSS-Global and YGTSS-Impairment) outcome measures and (b) analysis of covariance; and (2) longitudinal mixed-effects models.At end point, subjects treated with O3FA did not have significantly higher response rates or lower mean scores on the YGTSS-Tic (53% vs 38%; 15.6 ± 1.6 vs 17.1 ± 1.6, P > .1). However, significantly more subjects on O3FA were considered responders on the YGTSS-Global measure (53% vs 31%, P = .05) and YGTSS-Impairment measure (59% vs 25%, P < .05), and mean YGTSS-Global scores were significantly lower in the O3FA-treated group than in the placebo group (31.7 ± 2.9 vs 40.9 ± 3.0, P = .04). Obsessive-compulsive, anxiety, and depressive symptoms were not significantly affected by O3FA. Longitudinal analysis did not yield group differences on any of the measures.O3FA did not reduce tic scores, but it may be beneficial in reduction of tic-related impairment for some children and adolescents with TD. Limitations include the small sample and the possible therapeutic effects of olive oil.

SUBMITTER: Gabbay V

PROVIDER: S-EPMC3362909 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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A double-blind, placebo-controlled trial of ω-3 fatty acids in Tourette's disorder.

Gabbay Vilma V Babb James S JS Klein Rachel G RG Panzer Aviva M AM Katz Yisrael Y Alonso Carmen M CM Petkova Eva E Wang Jing J Coffey Barbara J BJ

Pediatrics 20120514 6

<h4>Objective</h4>Clinical observations have suggested therapeutic effects for ω-3 fatty acids (O3FA) in Tourette's disorder (TD), but no randomized, controlled trials have been reported. In a placebo-controlled trial, we examined the efficacy of O3FA in children and adolescents with TD.<h4>Methods</h4>Thirty-three children and adolescents (ages 6-18) with TD were randomly assigned, double-blind, to O3FA or placebo for 20 weeks. O3FA consisted of combined eicosapentaenoic acid and docosahexaenoi ...[more]

PMID: 22585765

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Project description:Aripiprazole modulates dopaminergic and serotonergic pathways that may play a role in the pathogenesis of Tourette's disorder (TD). This trial evaluated the efficacy and safety of oral aripiprazole in the suppression of tics in children and adolescents with TD.This phase 3, randomized, double-blind, placebo-controlled trial ( ClinicalTrials.gov , NCT01727700) recruited patients who were 7-17 years old with a diagnosis of TD from hospitals, private practices, and research clinics at 76 sites in the United States, Canada, Hungary, and Italy. Patients were randomized in a 1:1:1 ratio by using an interactive voice/web-response system to low-dose aripiprazole (5?mg/day if <50?kg; 10?mg/day if ?50?kg), high-dose aripiprazole (10?mg/day if <50?kg; 20?mg/day if ?50?kg), or placebo for 8 weeks. Randomization was stratified by region (North America or Europe) and baseline body weight (<50?kg vs. ?50?kg). The primary efficacy endpoint was mean change from baseline to week 8 in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS) for the intent-to-treat population.Between November 2012 and May 2013, 133 patients were recruited and randomized to low-dose aripiprazole (n?=?44), high-dose aripiprazole (n?=?45), or placebo (n?=?44). Least-squares mean treatment differences versus placebo in change from baseline to week 8 in the YGTSS-TTS were statistically significant (high dose, -9.9 [95% confidence interval, CI, -13.8 to -5.9], low dose, -6.3 [95% CI, -10.2 to -2.3]). At week 8, 69% (29/42) of patients in the low-dose and 74% (26/35) of patients in the high-dose aripiprazole groups demonstrated a Clinical Global Impression-Tourette's Syndrome improvement score of 1 (very much improved) or 2 (much improved) compared with 38% (16/42) in the placebo group. The most common adverse events (AEs) were sedation (low dose, 8/44 [18.2%], high dose, 4/45 [8.9%], placebo, 1/44 [2.3%]), somnolence (low dose, 5/44 [11.4%], high dose, 7/45 [15.6%], placebo, 1/44 [2.3%]), and fatigue (low dose, 3/44 [6.8%], high dose, 7/45 [15.6%], placebo, 0). No serious AEs or deaths occurred.This study indicates that oral aripiprazole is a safe and effective treatment for tics in children and adolescents with TD.

Project description:Diabetes refers to a group of metabolic diseases with blood glucose of higher than normal ranges. Furthermore, n-3 polyunsaturated fatty acids are necessary for the regulation of the activity of human function. The effect of n-3 PUFA on diabetes has been investigated in animal studies, yet, the exact amount has not been set, to date. Irisin, as a new myokine, is released from skeletal muscle and Irisin levels decrease as a result of physical inactivity, overweightness, and obesity. Also, the reduction of serum irisin level is associated with development of insulin resistance and type 2 diabetes. This study was performed to assess the effects of n-3 PUFA supplementation on serum irisin level in patients with diabetes.This randomized clinical trial included 43 patients with type 2 diabetes (21 patients in the placebo group and 22 patients in the n-3 PUFA supplement group). They were randomized to groups, one receiving 10 weeks of either n-3 PUFA supplement and the other the placebo (1250 mg capsule, three times per day). Samples were also matched by age, gender, and body mass index (BMI) in the 2 groups. Anthropometric measurements, demographic information and dietary intakes were obtained both before and after the intervention. Serum irisin levels were measured before and after the intervention using human irisin enzyme linked immunosorbent assay (ELISA) kit. Independent t-test was used to compare the mean outcomes between groups.At baseline, irisin serum levels were not significantly different between the placebo and n-3 PUFA supplementation groups (P > 0.05). However, a significant change was observed between the groups after intervention (P = 0.04). Also there was a significant difference in mean change (after versus before the intervention) (P = 0.05). Compared to the placebo, n-3 PUFA supplementation decreased serum FBS and HbA1C (P = 0.036 and 0.001; respectively). Also, there were significant differences between changes of diastolic blood pressure and HOMA-IR after the intervention between the groups. The duration of illness was not considered as a confounding factor because there was no significant association between irisin level (after versus before the intervention) and the illness duration.The current study indicated that n-3 PUFA supplementation with a dosage of 1250 mg three times per day, resulted in increased serum irisin level of diabetic patients.

Dataset Information

A double-blind, placebo-controlled trial of ?-3 fatty acids in Tourette's disorder.

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A double-blind, placebo-controlled trial of ω-3 fatty acids in Tourette's disorder.

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