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Tourette syndrome (TS) is a neurodevelopmental disorder characterized by the hyperkinetic movements of motor and phonic tics manifested in young age. Currently approved treatments in the United States are antipsychotics: haloperidol, pimozide, and aripiprazole, which are associated with serious side effects, including tardive dyskinesia (TD). Deutetrabenazine, a vesicular monoamine transporter type 2 (VMAT2) inhibitor, was approved in 2017 by the US FDA for the treatment of chorea associated with Huntington’s disease and TD. Three ongoing studies (Alternatives for Reducing Tics in TS [ARTISTS]) are evaluating the efficacy, safety, and tolerability of deutetrabenazine in reducing tics in TS in children and adolescents (age 6-16 years).
ARTISTS 1, a phase 2/3, response-driven, dose-titration, placebo-controlled study, randomizes patients (N=116) 1:1 to deutetrabenazine or placebo for 12 weeks. ARTISTS 2, a phase 3, fixed-dose study, randomizes patients (N=150) 1:1:1 to deutetrabenazine high or low dose, or placebo for 8 weeks. The primary efficacy outcome in these pivotal studies is change from baseline to end of treatment in the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS). Additional efficacy endpoints and safety/tolerability are also evaluated. ARTISTS is a 56-week, open-label, single-arm, long-term safety/tolerability study in patients who have successfully completed either ARTISTS 1 or ARTISTS 2.
Not available yet.
TS can have potentially long-term life impact, and there remains unmet medical need for effective and well-tolerated treatments. Three ARTISTS studies will evaluate the efficacy, safety, and tolerability of deutetrabenazine in patients with tics in TS.
The studies are sponsored by Teva Pharmaceuticals and operationalized by Teva’s development partner, Nuvelution TS Pharma INC.
Trichotillomania (TTM, repetitive hair pulling) is a complex underdiagnosed syndrome that often causes considerable psychological distress and physical disfigurement. Although many aspects of hair pulling bear similarity to compulsions of obsessive-compulsive disorder (OCD), TTM lacks obsessions associated with OCD. The phenomenology of TTM also is similar to tics in Tourette Syndrome (TS) and overlaps with TS in both limited structural neuroimaging data and in terms of treatment response to pharmacotherapy with dopamine antagonists.
In order to study potential comorbid relationships between TTM, TS, and OCD, a total of 61 patients with either TS, OCD, or OCD comorbid with TS were assessed using structured interviews as part of a phenomenological study of these groups. Post hoc analyses indicated significantly higher proportions of hair pulling in those subjects with OCD comorbid with TS compared to subjects with either OCD or TS alone.
These data, in conjunction with clinical phenomenology, neuroimaging results, and response to pharmacotherapy suggest the possibility that some forms of TTM may be more closely related to tic disorders than OCD. Futher research is needed to clarify and confirm these observations of putative relationships between TTM and TS and potential treatment implications.
Obsessive–compulsive disorder (OCD) is heterogeneous, with some forms related to Gilles de la Tourette's syndrome (GTS). This is a phenomenological study designed to investigate the nature of these possible OCD subtypes and the relationship between OCD and GTS.
We evaluated 20 adult outpatients with OCD, 21 with GTS, and 20 with OCD plus GTS using a semi-structured interview designed to assess cognitive, sensory and autonomic phenomena preceding repetitive behaviours.
More cognitions and autonomic anxiety and fewer sensory phenomena were reported in OCD than in GTS. Like the GTS group, the OCD plus GTS group reported more sensory phenomena and fewer cognitions than the OCD group.
The presence or absence of cognitions, sensory phenomena, and autonomic anxiety distinguishes repetitive behaviours in patients with OCD from those with OCD plus GTS, and GTS. These subjective experiences may be useful in subtyping OCD and may represent valid predictors of prognosis and treatment response.
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