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1.300 Cognitive impairments as diagnostic markers for ADHD: An overview
S76
Monday, 10 December 2007
effects were application site reaction (0.9%, 42.4%), nausea (4.4%, 16.6%), headache (9.6%, 15.7%), and dizziness (2.6%, 5.8%) for placebo and rotigotine, respectively. AEs were usually mild to moderate in intensity and transient. Conclusion: Therapy with the rotigotine transdermal system in doses from 1 to 3 mg/24 h over a period of 6 months was significantly and clinically relevantly superior to placebo and was well tolerated. Improvements were initially observed during the titration period and were sustained during 6 months follow-up period.
1.298 Transdermal lisuride in patients with idiopathic restless legs syndrome: Results from a placebo-controlled, double-blind 12-week dose-finding study with a 48-week open-label extension phase H. Benes1° , T.0. Study Group Germany
1 Schwerin,
Objective: The 8a-ergoline lisuride is a potent dopamine agonist with oral, subcutaneous, and transdermal (TTS, patch) forms. A previous pilot study showed favourable effects of transdermal lisuride in Restless Legs Syndrome (RLS). Method: This was a multicenter, randomized, double-blind, placebocontrolled dose-finding study with 12-week treatment in four treatment arms (lisuride TTS patches: 10, 20, 40 cm2 = 0.1, 0.2, and 0.4 mg/24 h Lisuride, placebo) applied every 48 hours. Open-label lisuride was applied afterwards until week 48. Efficacy was assessed with the IRLS, the RLS-6 scales, CGI, SF-A quality of sleep and QoL-RLS quality of life questionnaire. Statistical analysis was based upon ANCOVA. Results: 210 severely disabled RLS patients (70% females, age 60 years) with symptoms during the day were randomized. The IRLS total score improved dependent on dose between baseline (mean: 28.8) and endpoint as follows: Placebo: −9.5, 10cm2 : −14.7, 20cm2 : −18.4, 40cm2 : −18.9; all active doses of Lisuride TTS were superior to placebo (p = 0.0148 for 10 cm2 , p < 0.0001 for others). Responder rates (50% improvement from baseline) were: 26.9%, 43.4%, 62.3%, and 66.0% (placebo to 40 cm2 ). In CGI change item, rates of patients who improved “much” or “very much” were 44.2%, 58.5%, 66.0%, 80.0%. Tiredness during the day (RLS-6) and sleep quality were improved by all doses of lisuride TTS. Improvement of IRLS total score was stable during the open-label treatment (−16.2 at week 48, p < 0.0001). Most frequent drug-related adverse events (AEs) were local skin reactions, mainly pruritus and erythema, and gastrointestinal symptoms, mainly nausea. Conclusion: Our results indicate that very positive results can be obtained in severe RLS by continuous dopaminergic stimulation (CDS) using transdermal lisuride applied every other morning.
1.299 Head-to-head comparison of transdermal lisuride and oral ropinirole in Restless Legs Syndrome: Results from the first placebo- and active-controlled, double-blind, randomized, 12-week efficacy trial H. Benes1° , B. H¨ogl, C. Trenkwalder, K. Stiasny-Kolster, D. Palla, R. Kohnen, T.0. Study Group 1 Schwerin, Germany Objective: Leading experts agree that continuous compared to pulsatile oral dopaminergic stimulation could greatly improve therapeutic efficiency in neurological disease. Method: This was a multicenter, double-blind, randomized, active- and placebo-controlled, parallel-group, flexible dose, efficacy trial with 12-week treatment in three groups: lisuride TTS patches: 10, 20, 30 cm2 every other morning = 0.1, 0.2, and 0.3 mg/24 h lisuride; ropinirole: dose range: 1.0 mg to 3.0 mg/day, placebo. Dose was individually optimized during eight weeks. Efficacy was assessed with the IRLS.
Results: 309 severely disabled RLS patients (74% females, age 59 years) were randomized to lisuride (157 patients), ropinirole (78), or placebo (79). The IRLS total score improved between baseline (mean: 28.0) and endpoint as follows: Lisuride: −14.6, ropinirole: −11.6, placebo: −6.9. Compared to placebo, improvements were significantly larger under lisuride (difference between both groups: d = −7.5, p < 0.0001) and ropinirole (d = −4.9, p = 0.0032), lisuride in tendency was also more efficacious than ropinirole: d = 2.6, p = 0.076, 95% CI: −5.9; +0.7). IRLS responder rates (50% improvement from baseline) were higher under lisuride (56.1%) than under placebo (26.0%, p < 0.0001) and ropinirole (41.3%, p = 0.0470) (ropinirole versus placebo: p = 0.0587). Most frequent drug-related adverse events were local skin reactions under lisuride (24.3%), and under ropinirole nausea (35.9%), fatigue (17.9%) and headache (14.1%) (lisuride: 19.7%, 11.2%, 6.6%, placebo: 6.3%, 8.9%, 12.7%). Conclusion: Transdermal lisuride and oral ropinirole were effective in the treatment of severe RLS. Clinically relevant relief from RLS symptoms was more favourable and dopaminergic side effects occurred with a lower incidence under continuous dopaminergic stimulation with transdermal lisuride than with oral ropinirole. Local skin reactions at the application site are associated with the patch treatment.
1.300 Cognitive impairments as diagnostic markers for ADHD: An overview R. Gupta1° , B.R. Kar India
1 Allahabad,
Objective: To present an overview about the recommended approach to diagnose ADHD and discuss about the importance of specific cognitive dysfunctions with empirical data to make a case for the involvement of cognitive deficits as diagnostic markers for ADHD. Method: Existing behavioural measures to diagnose ADHD such as rating scales and continuous performance tests and recent experimental literature on cognitive impairments in ADHD was reviewed. Specific cognitive impairments such as disinhibition, attentional disengagement, error monitoring, and delay aversion in ADHD were found to be critical for the diagnosis of ADHD. We also conducted a study to investigate the specific cognitive markers based on the review. We administered computer based Attentional Disengagement Task, Stop-signal Task, and Delay Aversion Tasks on 85 normal children and 21 children with ADHD-combined type in the age range of 6 to 9 years. Mean±SD was computed to calculate the sensitivity and specificity for each parameter for all the tasks. Results: Results of our study validate our assumption. Following parameters were found to be highly sensitive and specific to dissociate ADHD children from normal children: Mean delay (85.2% sensitive and 79.9% specific); Post-error slowing (95.2% sensitive and 100% specific); Stop signal reaction time (100% sensitive and 78.5% specific); Switch cost (89.6% sensitive and 85.4% specific); Short delay reward (100% sensitive and 100% specific); Large delay reward (100% sensitive and 100% specific). Conclusion: All the recommended approaches for the diagnosis of ADHD have been critically reviewed which highlights the fact that specific cognitive mechanism underlying ADHD should be incorporated in the diagnostic system which will improve the diagnosis procedure. As our empirical data also show that there are some cognitive parameters or markers which could better dissociate ADHD children from normal children. Further more analysis with other neurodevelopmental disorder is needed to validate our empirical data.
Monday, 10 December 2007
effects were application site reaction (0.9%, 42.4%), nausea (4.4%, 16.6%), headache (9.6%, 15.7%), and dizziness (2.6%, 5.8%) for placebo and rotigotine, respectively. AEs were usually mild to moderate in intensity and transient. Conclusion: Therapy with the rotigotine transdermal system in doses from 1 to 3 mg/24 h over a period of 6 months was significantly and clinically relevantly superior to placebo and was well tolerated. Improvements were initially observed during the titration period and were sustained during 6 months follow-up period.
1.298 Transdermal lisuride in patients with idiopathic restless legs syndrome: Results from a placebo-controlled, double-blind 12-week dose-finding study with a 48-week open-label extension phase H. Benes1° , T.0. Study Group Germany
1 Schwerin,
Objective: The 8a-ergoline lisuride is a potent dopamine agonist with oral, subcutaneous, and transdermal (TTS, patch) forms. A previous pilot study showed favourable effects of transdermal lisuride in Restless Legs Syndrome (RLS). Method: This was a multicenter, randomized, double-blind, placebocontrolled dose-finding study with 12-week treatment in four treatment arms (lisuride TTS patches: 10, 20, 40 cm2 = 0.1, 0.2, and 0.4 mg/24 h Lisuride, placebo) applied every 48 hours. Open-label lisuride was applied afterwards until week 48. Efficacy was assessed with the IRLS, the RLS-6 scales, CGI, SF-A quality of sleep and QoL-RLS quality of life questionnaire. Statistical analysis was based upon ANCOVA. Results: 210 severely disabled RLS patients (70% females, age 60 years) with symptoms during the day were randomized. The IRLS total score improved dependent on dose between baseline (mean: 28.8) and endpoint as follows: Placebo: −9.5, 10cm2 : −14.7, 20cm2 : −18.4, 40cm2 : −18.9; all active doses of Lisuride TTS were superior to placebo (p = 0.0148 for 10 cm2 , p < 0.0001 for others). Responder rates (50% improvement from baseline) were: 26.9%, 43.4%, 62.3%, and 66.0% (placebo to 40 cm2 ). In CGI change item, rates of patients who improved “much” or “very much” were 44.2%, 58.5%, 66.0%, 80.0%. Tiredness during the day (RLS-6) and sleep quality were improved by all doses of lisuride TTS. Improvement of IRLS total score was stable during the open-label treatment (−16.2 at week 48, p < 0.0001). Most frequent drug-related adverse events (AEs) were local skin reactions, mainly pruritus and erythema, and gastrointestinal symptoms, mainly nausea. Conclusion: Our results indicate that very positive results can be obtained in severe RLS by continuous dopaminergic stimulation (CDS) using transdermal lisuride applied every other morning.
1.299 Head-to-head comparison of transdermal lisuride and oral ropinirole in Restless Legs Syndrome: Results from the first placebo- and active-controlled, double-blind, randomized, 12-week efficacy trial H. Benes1° , B. H¨ogl, C. Trenkwalder, K. Stiasny-Kolster, D. Palla, R. Kohnen, T.0. Study Group 1 Schwerin, Germany Objective: Leading experts agree that continuous compared to pulsatile oral dopaminergic stimulation could greatly improve therapeutic efficiency in neurological disease. Method: This was a multicenter, double-blind, randomized, active- and placebo-controlled, parallel-group, flexible dose, efficacy trial with 12-week treatment in three groups: lisuride TTS patches: 10, 20, 30 cm2 every other morning = 0.1, 0.2, and 0.3 mg/24 h lisuride; ropinirole: dose range: 1.0 mg to 3.0 mg/day, placebo. Dose was individually optimized during eight weeks. Efficacy was assessed with the IRLS.
Results: 309 severely disabled RLS patients (74% females, age 59 years) were randomized to lisuride (157 patients), ropinirole (78), or placebo (79). The IRLS total score improved between baseline (mean: 28.0) and endpoint as follows: Lisuride: −14.6, ropinirole: −11.6, placebo: −6.9. Compared to placebo, improvements were significantly larger under lisuride (difference between both groups: d = −7.5, p < 0.0001) and ropinirole (d = −4.9, p = 0.0032), lisuride in tendency was also more efficacious than ropinirole: d = 2.6, p = 0.076, 95% CI: −5.9; +0.7). IRLS responder rates (50% improvement from baseline) were higher under lisuride (56.1%) than under placebo (26.0%, p < 0.0001) and ropinirole (41.3%, p = 0.0470) (ropinirole versus placebo: p = 0.0587). Most frequent drug-related adverse events were local skin reactions under lisuride (24.3%), and under ropinirole nausea (35.9%), fatigue (17.9%) and headache (14.1%) (lisuride: 19.7%, 11.2%, 6.6%, placebo: 6.3%, 8.9%, 12.7%). Conclusion: Transdermal lisuride and oral ropinirole were effective in the treatment of severe RLS. Clinically relevant relief from RLS symptoms was more favourable and dopaminergic side effects occurred with a lower incidence under continuous dopaminergic stimulation with transdermal lisuride than with oral ropinirole. Local skin reactions at the application site are associated with the patch treatment.
1.300 Cognitive impairments as diagnostic markers for ADHD: An overview R. Gupta1° , B.R. Kar India
1 Allahabad,
Objective: To present an overview about the recommended approach to diagnose ADHD and discuss about the importance of specific cognitive dysfunctions with empirical data to make a case for the involvement of cognitive deficits as diagnostic markers for ADHD. Method: Existing behavioural measures to diagnose ADHD such as rating scales and continuous performance tests and recent experimental literature on cognitive impairments in ADHD was reviewed. Specific cognitive impairments such as disinhibition, attentional disengagement, error monitoring, and delay aversion in ADHD were found to be critical for the diagnosis of ADHD. We also conducted a study to investigate the specific cognitive markers based on the review. We administered computer based Attentional Disengagement Task, Stop-signal Task, and Delay Aversion Tasks on 85 normal children and 21 children with ADHD-combined type in the age range of 6 to 9 years. Mean±SD was computed to calculate the sensitivity and specificity for each parameter for all the tasks. Results: Results of our study validate our assumption. Following parameters were found to be highly sensitive and specific to dissociate ADHD children from normal children: Mean delay (85.2% sensitive and 79.9% specific); Post-error slowing (95.2% sensitive and 100% specific); Stop signal reaction time (100% sensitive and 78.5% specific); Switch cost (89.6% sensitive and 85.4% specific); Short delay reward (100% sensitive and 100% specific); Large delay reward (100% sensitive and 100% specific). Conclusion: All the recommended approaches for the diagnosis of ADHD have been critically reviewed which highlights the fact that specific cognitive mechanism underlying ADHD should be incorporated in the diagnostic system which will improve the diagnosis procedure. As our empirical data also show that there are some cognitive parameters or markers which could better dissociate ADHD children from normal children. Further more analysis with other neurodevelopmental disorder is needed to validate our empirical data.