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      The CANNA-TICS Study Protocol: A Randomized Multi-Center Double-Blind Placebo Controlled Trial to Demonstrate the Efficacy and Safety of Nabiximols in the Treatment of Adults With Chronic Tic Disorders

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          Abstract

          Background: Gilles de la Tourette syndrome (TS) is a chronic neuropsychiatric disorder characterized by motor and vocal tics. First-line treatments for tics are antipsychotics and tic-specific behavioral therapies. However, due to a lack of trained therapists and adverse events of antipsychotic medication many patients seek alternative treatment options including cannabis. Based on the favorable results obtained from case studies on different cannabis-based medicines as well as two small randomized controlled trials using delta-9-tetrahydrocannabinol (THC), we hypothesize that the cannabis extract nabiximols can be regarded as a promising new and safe treatment strategy in TS.

          Objective: To test in a double blind randomized clinical trial, whether treatment with the cannabis extract nabiximols is superior to placebo in patients with chronic tic disorders.

          Patients and Methods: This is a multicenter, randomized, double-blind, placebo controlled, parallel-group, phase IIIb trial, which aims to enroll 96 adult patients with chronic tic disorders (TS or chronic motor tic disorder) across 6 centers throughout Germany. Patients will be randomized with a 2:1 ratio into a nabiximols and a placebo arm. The primary efficacy endpoint is defined as tic reduction of at least 30% (compared to baseline) according to the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) after 13 weeks of treatment. In addition, several secondary endpoints will be assessed including changes in different psychiatric comorbidities, quality of life, driving ability, and safety assessments.

          Discussion: This will be the first large, controlled study investigating efficacy and safety of a cannabis-based medicine in patients with TS. Based on available data using different cannabis-based medicines, we expect not only a reduction of tics, but also an improvement of psychiatric comorbidities. If the cannabis extract nabiximols is proven to be safe and effective, it will be a valuable alternative treatment option. The results of this study will be of high health-economic relevance, because a substantial number of patients uses cannabis (illegally) as self-medication.

          Conclusion: The CANNA-TICS trial will clarify whether nabiximols is efficacious and safe in the treatment of patients with chronic tic disorders.

          Clinical Trial Registration: This trial is registered at clinicaltrialsregister.eu (Eudra-CT 2016-000564-42) and clinicaltrials.gov (NCT03087201).

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          Most cited references34

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          The Pittsburgh sleep quality index: A new instrument for psychiatric practice and research

          Despite the prevalence of sleep complaints among psychiatric patients, few questionnaires have been specifically designed to measure sleep quality in clinical populations. The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Clinical and clinimetric properties of the PSQI were assessed over an 18-month period with "good" sleepers (healthy subjects, n = 52) and "poor" sleepers (depressed patients, n = 54; sleep-disorder patients, n = 62). Acceptable measures of internal homogeneity, consistency (test-retest reliability), and validity were obtained. A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p less than 0.001) in distinguishing good and poor sleepers. The clinimetric and clinical properties of the PSQI suggest its utility both in psychiatric clinical practice and research activities.
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            A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.

            Regression methods were used to select and score 12 items from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to reproduce the Physical Component Summary and Mental Component Summary scales in the general US population (n=2,333). The resulting 12-item short-form (SF-12) achieved multiple R squares of 0.911 and 0.918 in predictions of the SF-36 Physical Component Summary and SF-36 Mental Component Summary scores, respectively. Scoring algorithms from the general population used to score 12-item versions of the two components (Physical Components Summary and Mental Component Summary) achieved R squares of 0.905 with the SF-36 Physical Component Summary and 0.938 with SF-36 Mental Component Summary when cross-validated in the Medical Outcomes Study. Test-retest (2-week)correlations of 0.89 and 0.76 were observed for the 12-item Physical Component Summary and the 12-item Mental Component Summary, respectively, in the general US population (n=232). Twenty cross-sectional and longitudinal tests of empirical validity previously published for the 36-item short-form scales and summary measures were replicated for the 12-item Physical Component Summary and the 12-item Mental Component Summary, including comparisons between patient groups known to differ or to change in terms of the presence and seriousness of physical and mental conditions, acute symptoms, age and aging, self-reported 1-year changes in health, and recovery for depression. In 14 validity tests involving physical criteria, relative validity estimates for the 12-item Physical Component Summary ranged from 0.43 to 0.93 (median=0.67) in comparison with the best 36-item short-form scale. Relative validity estimates for the 12-item Mental Component Summary in 6 tests involving mental criteria ranged from 0.60 to 107 (median=0.97) in relation to the best 36-item short-form scale. Average scores for the 2 summary measures, and those for most scales in the 8-scale profile based on the 12-item short-form, closely mirrored those for the 36-item short-form, although standard errors were nearly always larger for the 12-item short-form.
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              An Inventory for Measuring Depression

              A. Beck (1961)
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                Author and article information

                Contributors
                Journal
                Front Psychiatry
                Front Psychiatry
                Front. Psychiatry
                Frontiers in Psychiatry
                Frontiers Media S.A.
                1664-0640
                26 November 2020
                2020
                : 11
                : 575826
                Affiliations
                [1] 1Clinic of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School , Hannover, Germany
                [2] 2Clinical Research Center Core Facility, Hannover Medical School , Hannover, Germany
                [3] 3Center for Pharmacology and Toxicology, Hannover Medical School , Hannover, Germany
                [4] 4Hannover Medical School, Institute for Biostatistics , Hannover, Germany
                [5] 5Section Biostatistics, Paul-Ehrlich-Institute , Langen, Germany
                [6] 6Department of Neuropsychology, Kbo-Inn-Salzach-Klinikum, Psychiatric Hospital , Wasserburg am Inn, Germany
                [7] 7Department of Psychiatry and Psychotherapy, Ludwig-Maximilians University Munich , Munich, Germany
                [8] 8Institute of Physiological Chemistry, University Medical Center of the Johannes Gutenberg University , Mainz, Germany
                Author notes

                Edited by: Trevor Ronald Norman, The University of Melbourne, Australia

                Reviewed by: Seth Davin Norrholm, Wayne State University, United States; A. Cavanna, Birmingham and Solihull Mental Health NHS Foundation Trust, United Kingdom

                *Correspondence: Kirsten Müller-Vahl mueller-vahl.kirsten@ 123456mh-hannover.de

                This article was submitted to Molecular Psychiatry, a section of the journal Frontiers in Psychiatry

                Article
                10.3389/fpsyt.2020.575826
                7725747
                33324255
                13a15cb1-688e-49bb-869f-23d4631b254e
                Copyright © 2020 Jakubovski, Pisarenko, Fremer, Haas, May, Schumacher, Schindler, Häckl, Aguirre Davila, Koch, Brunnauer, Cimpianu, Lutz, Bindila and Müller-Vahl.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 25 June 2020
                : 02 November 2020
                Page count
                Figures: 2, Tables: 1, Equations: 0, References: 34, Pages: 10, Words: 6894
                Funding
                Funded by: Deutsche Forschungsgemeinschaft 10.13039/501100001659
                Award ID: MU 1527/2-1
                Categories
                Psychiatry
                Study Protocol

                Clinical Psychology & Psychiatry
                cannabidiol,thc,tetrahydrocannabinol,cannabinoids,nabiximols,chronic tic disorder,tics,tourette syndrome

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