LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 10 of total 12

Search options

  1. Article ; Online: Effect on Primary Sleep Disorders When Children With ADHD Are Administered Guanfacine Extended Release.

    Rugino, Thomas A

    Journal of attention disorders

    2014  

    Abstract: Objective: To evaluate children with ADHD and sleep problems with polysomnography (PSG) after guanfacine extended-release (GXR) administration.: Method: Double-blind, randomized, placebo-controlled study was terminated early due to treatment-emergent ...

    Abstract Objective: To evaluate children with ADHD and sleep problems with polysomnography (PSG) after guanfacine extended-release (GXR) administration.
    Method: Double-blind, randomized, placebo-controlled study was terminated early due to treatment-emergent concerns after enrolling 29 children aged 6 to 12 years. After >4 weeks dose adjustment and >1 week dose stabilization, 11 children received GXR and 16 controls underwent analyses with PSG.
    Results: Although GXR improved ADHD symptoms, the primary outcome variable, total sleep time, was shorter in contrast to placebo (-57.32, SD = 89.17 vs. +31.32, SD = 59.54 min, p = .005). Increased time awake after sleep onset per hour of sleep was the primary factor for the reduction. Although rapid eye movement (REM), non-REM, and N3/slow wave sleep times were reduced, these were proportional to the overall sleep reduction. Sedation was common with GXR (73% vs. 6%).
    Conclusion: Morning-administered GXR resulted in decreased sleep and may contribute to sedation.
    Language English
    Publishing date 2014-11-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2004350-8
    ISSN 1557-1246 ; 1087-0547
    ISSN (online) 1557-1246
    ISSN 1087-0547
    DOI 10.1177/1087054714554932
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  2. Article: A review of modafinil film-coated tablets for attention-deficit/hyperactivity disorder in children and adolescents.

    Rugino, Thomas

    Neuropsychiatric disease and treatment

    2009  Volume 3, Issue 3, Page(s) 293–301

    Abstract: Modafinil, a wakefulness-promoting agent unrelated to classical sympathomimetic stimulants, has been studied in a total of 933 children and adolescents as a treatment for attention-deficit/hyperactivity disorder (ADHD). Several studies, including three ... ...

    Abstract Modafinil, a wakefulness-promoting agent unrelated to classical sympathomimetic stimulants, has been studied in a total of 933 children and adolescents as a treatment for attention-deficit/hyperactivity disorder (ADHD). Several studies, including three double-blind, placebo-controlled studies with intent-to-treat analyses, have demonstrated the efficacy of modafinil film-coated tablets in reducing symptoms of ADHD and associated problem behaviors in children and adolescents. Modafinil is generally well tolerated, with adverse events (such as insomnia, headache, loss of appetite, weight loss, and gastrointestinal discomfort) that are generally mild to moderate, rarely leading to medication discontinuation. To minimize treatment-emergent side effects, titration to the target dose of 355-425 mg once a day should take place over 2-3 weeks. Due to reports of skin rash (including one case of possible erythema multiforme/Stevens Johnson Syndrome during pivotal studies), additional studies have been requested to better evaluate the risks of developing severe cutaneous adverse reactions.
    Language English
    Publishing date 2009-03-20
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2186503-6
    ISSN 1178-2021 ; 1176-6328
    ISSN (online) 1178-2021
    ISSN 1176-6328
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  3. Article ; Online: Commentary: Objective aids for the assessment of ADHD - further clarification of what FDA approval for marketing means and why NEBA might help clinicians. A response to Arns et al. (2016).

    Stein, Mark A / Snyder, Steven M / Rugino, Thomas A / Hornig, Mady

    Journal of child psychology and psychiatry, and allied disciplines

    2016  Volume 57, Issue 6, Page(s) 770–771

    Abstract: Neuropsychiatric EEG-Based ADHD Assessment Aid (NEBA) is an EEG-based device designed to aid in the diagnostic process for ADHD by identifying individuals less likely to have ADHD by virtue of a lower theta/beta ratio. In using NEBA as an example, the ... ...

    Abstract Neuropsychiatric EEG-Based ADHD Assessment Aid (NEBA) is an EEG-based device designed to aid in the diagnostic process for ADHD by identifying individuals less likely to have ADHD by virtue of a lower theta/beta ratio. In using NEBA as an example, the Arns et al. commentary misstates the purpose of NEBA, which is to widen the differential rather than to make the diagnosis. Arns et al. caution about missing an ADHD diagnosis, but fail to mention the impact of overdiagnosis. If we are to advance our knowledge of the etiology and pathophysiology of ADHD, as well as develop tailored treatments and ultimately improve outcomes for ADHD, then biomarkers and objective assessment aids such as NEBA are needed to improve and refine diagnostic accuracy beyond symptom description and clinical history.
    MeSH term(s) Attention Deficit Disorder with Hyperactivity ; Electroencephalography ; Humans ; Marketing
    Language English
    Publishing date 2016
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 218136-8
    ISSN 1469-7610 ; 0021-9630 ; 0373-8086
    ISSN (online) 1469-7610
    ISSN 0021-9630 ; 0373-8086
    DOI 10.1111/jcpp.12534
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  4. Article ; Online: Integration of an EEG biomarker with a clinician's ADHD evaluation.

    Snyder, Steven M / Rugino, Thomas A / Hornig, Mady / Stein, Mark A

    Brain and behavior

    2015  Volume 5, Issue 4, Page(s) e00330

    Abstract: Background: This study is the first to evaluate an assessment aid for attention-deficit/hyperactivity disorder (ADHD) according to both Class-I evidence standards of American Academy of Neurology and De Novo requirements of US Food and Drug ... ...

    Abstract Background: This study is the first to evaluate an assessment aid for attention-deficit/hyperactivity disorder (ADHD) according to both Class-I evidence standards of American Academy of Neurology and De Novo requirements of US Food and Drug Administration. The assessment aid involves a method to integrate an electroencephalographic (EEG) biomarker, theta/beta ratio (TBR), with a clinician's ADHD evaluation. The integration method is intended as a step to help improve certainty with criterion E (i.e., whether symptoms are better explained by another condition).
    Methods: To evaluate the assessment aid, investigators conducted a prospective, triple-blinded, 13-site, clinical cohort study. Comprehensive clinical evaluation data were obtained from 275 children and adolescents presenting with attentional and behavioral concerns. A qualified clinician at each site performed differential diagnosis. EEG was collected by separate teams. The reference standard was consensus diagnosis by an independent, multidisciplinary team (psychiatrist, psychologist, and neurodevelopmental pediatrician), which is well-suited to evaluate criterion E in a complex clinical population.
    Results: Of 209 patients meeting ADHD criteria per a site clinician's judgment, 93 were separately found by the multidisciplinary team to be less likely to meet criterion E, implying possible overdiagnosis by clinicians in 34% of the total clinical sample (93/275). Of those 93, 91% were also identified by EEG, showing a relatively lower TBR (85/93). Further, the integration method was in 97% agreement with the multidisciplinary team in the resolution of a clinician's uncertain cases (35/36). TBR showed statistical power specific to supporting certainty of criterion E per the multidisciplinary team (Cohen's d, 1.53). Patients with relatively lower TBR were more likely to have other conditions that could affect criterion E certainty (10 significant results; P ≤ 0.05). Integration of this information with a clinician's ADHD evaluation could help improve diagnostic accuracy from 61% to 88%.
    Conclusions: The EEG-based assessment aid may help improve accuracy of ADHD diagnosis by supporting greater criterion E certainty.
    MeSH term(s) Adolescent ; Attention Deficit Disorder with Hyperactivity/diagnosis ; Biomarkers/analysis ; Child ; Child, Preschool ; Diagnosis, Differential ; Electroencephalography/methods ; Female ; Humans ; Male ; Prospective Studies ; United States
    Chemical Substances Biomarkers
    Language English
    Publishing date 2015-04
    Publishing country United States
    Document type Evaluation Studies ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 2623587-0
    ISSN 2162-3279 ; 2162-3279
    ISSN (online) 2162-3279
    ISSN 2162-3279
    DOI 10.1002/brb3.330
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  5. Article ; Online: Morning and Evening Effects of Guanfacine Extended Release Adjunctive to Psychostimulants in Pediatric ADHD.

    Wilens, Timothy E / McBurnett, Keith / Turnbow, John / Rugino, Thomas / White, Carla / Youcha, Sharon

    Journal of attention disorders

    2016  Volume 21, Issue 2, Page(s) 110–119

    Abstract: Objective: To examine efficacy and safety of adjunctive guanfacine extended release (GXR) on morning and evening ADHD symptoms using the Conners' Global Index-Parent (CGI-P) and Before-School Functioning Questionnaire (BSFQ).: Method: Participants 6 ... ...

    Abstract Objective: To examine efficacy and safety of adjunctive guanfacine extended release (GXR) on morning and evening ADHD symptoms using the Conners' Global Index-Parent (CGI-P) and Before-School Functioning Questionnaire (BSFQ).
    Method: Participants 6 to 17 years with ADHD ( N = 461) and suboptimal psychostimulant response were maintained on current psychostimulants and randomized to dose-optimized GXR (≤4 mg/d) in the morning (GXR AM) or evening (GXR PM), or placebo.
    Results: CGI-P scores improved with GXR (morning assessment, GXR AM, placebo-adjusted least squares [LS] mean = -1.7, GXR PM = -2.6; evening assessment, GXR AM = -2.4, GXR PM = -3.0; all ps < .01). Parent-rated BSFQ scores reflected improved morning functioning with GXR (GXR AM, placebo-adjusted LS mean = -5.1; GXR PM = -4.7; both ps < .01). Most adverse events were mild or moderate.
    Conclusion: Adjunctive GXR AM or GXR PM was associated with improvements in morning and evening ADHD symptoms in children and adolescents.
    MeSH term(s) Adolescent ; Adrenergic alpha-2 Receptor Agonists/administration & dosage ; Adrenergic alpha-2 Receptor Agonists/adverse effects ; Amphetamine/administration & dosage ; Amphetamine/adverse effects ; Analysis of Variance ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Central Nervous System Stimulants/administration & dosage ; Central Nervous System Stimulants/adverse effects ; Child ; Delayed-Action Preparations ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Guanfacine/administration & dosage ; Guanfacine/adverse effects ; Humans ; Male ; Methylphenidate/administration & dosage ; Methylphenidate/adverse effects ; Parents ; Schools ; Treatment Outcome
    Chemical Substances Adrenergic alpha-2 Receptor Agonists ; Central Nervous System Stimulants ; Delayed-Action Preparations ; Methylphenidate (207ZZ9QZ49) ; Guanfacine (30OMY4G3MK) ; Amphetamine (CK833KGX7E)
    Language English
    Publishing date 2016-07-28
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2004350-8
    ISSN 1557-1246 ; 1087-0547
    ISSN (online) 1557-1246
    ISSN 1087-0547
    DOI 10.1177/1087054713500144
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  6. Article: Aripiprazole in children and adolescents: clinical experience.

    Rugino, Thomas A / Janvier, Yvette M

    Journal of child neurology

    2005  Volume 20, Issue 7, Page(s) 603–610

    Abstract: Despite few supportive data, aripiprazole was being administered to children and adolescents for management of mood instability, aggression, and psychosis. Using a retrospective review (n = 11) and prospective recruitment (n = 6), 17 children and ... ...

    Abstract Despite few supportive data, aripiprazole was being administered to children and adolescents for management of mood instability, aggression, and psychosis. Using a retrospective review (n = 11) and prospective recruitment (n = 6), 17 children and adolescents received aripiprazole 5 to 20 mg/day. Only 4 of 16 bipolar and autistic subjects (25%) demonstrated reduced aggression without adverse events, and the symptoms of 2 of 4 psychotic subjects improved. Coadministration of sedative medications (particularly guanfacine or clonidine) and weight < 58 kg increased the risk of adverse events, such as increased lability and aggression. All three children < 8.6 years old, all four children < 34 kg, and all five children receiving alpha2-agonists developed adverse events prior to clinical efficacy. Age > 11 years, weight > 58 kg, and absence of sedative medications were associated with a 56% (five of nine) success rate. Until larger, prospective studies are completed, caution is advised when considering aripiprazole for smaller children and children receiving sedative medications.
    MeSH term(s) Adolescent ; Antipsychotic Agents/administration & dosage ; Antipsychotic Agents/adverse effects ; Antipsychotic Agents/therapeutic use ; Aripiprazole ; Attention Deficit and Disruptive Behavior Disorders/etiology ; Attention Deficit and Disruptive Behavior Disorders/prevention & control ; Bipolar Disorder/psychology ; Child ; Child Behavior Disorders/drug therapy ; Child Behavior Disorders/psychology ; Child, Preschool ; Dose-Response Relationship, Drug ; Female ; Humans ; Male ; Piperazines/administration & dosage ; Piperazines/adverse effects ; Piperazines/therapeutic use ; Prospective Studies ; Quinolones/administration & dosage ; Quinolones/adverse effects ; Quinolones/therapeutic use ; Retrospective Studies ; Treatment Outcome ; Treatment Refusal
    Chemical Substances Antipsychotic Agents ; Piperazines ; Quinolones ; Aripiprazole (82VFR53I78)
    Language English
    Publishing date 2005-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 639288-x
    ISSN 1708-8283 ; 0883-0738
    ISSN (online) 1708-8283
    ISSN 0883-0738
    DOI 10.1177/08830738050200071301
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  7. Article ; Online: Efficacy of guanfacine extended release assessed during the morning, afternoon, and evening using a modified Conners' Parent Rating Scale-revised: Short Form.

    Young, Joel / Rugino, Thomas / Dammerman, Ryan / Lyne, Andrew / Newcorn, Jeffrey H

    Journal of child and adolescent psychopharmacology

    2014  Volume 24, Issue 8, Page(s) 435–441

    Abstract: Objective: The purpose of this study was to evaluate the efficacy of once-daily guanfacine extended release (GXR) monotherapy administered either in the morning or evening, using a modified Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) ... ...

    Abstract Objective: The purpose of this study was to evaluate the efficacy of once-daily guanfacine extended release (GXR) monotherapy administered either in the morning or evening, using a modified Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) assessed three times/day in children with attention-deficit/hyperactivity disorder (ADHD).
    Methods: This multicenter, double-blind, placebo-controlled study randomized children 6-12 years of age with ADHD into three groups: GXR a.m. (GXR in the morning and placebo in the evening), GXR p.m. (placebo in the morning and GXR in the evening), or twice-daily placebo. The CPRS-R:S, administered in the morning, afternoon, and evening prior to each study visit, was a secondary measure of efficacy.
    Results: A total of 333 subjects were included in the analysis population (GXR a.m., n=107; GXR p.m., n=114; placebo, n=112). At visit 10, last observation carried forward (LOCF), subjects receiving GXR demonstrated significantly greater improvement from baseline in the daily mean CPRS-R:S total score, as well as in each of the morning, afternoon, and evening CPRS-R:S assessments, compared with placebo, regardless of the time of GXR administration (p<0.001 vs. placebo for GXR a.m. and GXR p.m.). In addition, subjects receiving GXR showed significantly greater improvements from baseline in each subscale score (oppositional, cognitive problems/inattention, hyperactivity, and ADHD index) compared with those receiving placebo, regardless of time of administration (p<0.003 vs. placebo across all subscales for GXR a.m. and GXR p.m.).
    Conclusions: These results provide further support for the demonstrated efficacy of once-daily GXR in reducing ADHD symptoms, and demonstrate that response is consistent throughout the day regardless of the time of administration, with improvement seen in ratings of oppositional as well as of ADHD symptoms.
    MeSH term(s) Attention Deficit Disorder with Hyperactivity/drug therapy ; Child ; Delayed-Action Preparations ; Double-Blind Method ; Drug Administration Schedule ; Female ; Guanfacine/adverse effects ; Guanfacine/therapeutic use ; Humans ; Male ; Parents ; Severity of Illness Index ; Treatment Outcome
    Chemical Substances Delayed-Action Preparations ; Guanfacine (30OMY4G3MK)
    Language English
    Publishing date 2014-10-06
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 1055410-5
    ISSN 1557-8992 ; 1044-5463
    ISSN (online) 1557-8992
    ISSN 1044-5463
    DOI 10.1089/cap.2013.0134
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  8. Article: Modafinil in children with attention-deficit hyperactivity disorder.

    Rugino, Thomas A / Samsock, Teresa C

    Pediatric neurology

    2003  Volume 29, Issue 2, Page(s) 136–142

    Abstract: Previous clinical evidence suggested that modafinil may improve clinical features of children with attention-deficit hyperactivity disorder. To test this hypothesis, a randomized, double-blind, placebo-controlled study design was used. Of 24 children ... ...

    Abstract Previous clinical evidence suggested that modafinil may improve clinical features of children with attention-deficit hyperactivity disorder. To test this hypothesis, a randomized, double-blind, placebo-controlled study design was used. Of 24 children initially randomized into the study, 11 control subjects and 11 treatment patients completed the study, with evaluation before medication and after 5 to 6 weeks. The average Test of Variables of Attention attention-deficit hyperactivity disorder z score improved by 2.53 S.D.s for the modafinil group compared with a decline of 1.02 for control patients (P < or = 0.02). Conners Rating Scales ADHD total t scores for the modafinil group improved from 76.6 to 68.2 compared with improvement from 77.7 to 76.0 for control subjects (P = 0.04). Ten of 11 treatment patients were reported as "significantly" improved, whereas eight of 11 control subjects were reported as manifesting "no" or "slight" improvement (P < 0.001). Adverse effects were few and manageable, with no anorexia. Modafinil may be a useful treatment for children with ADHD, particularly when anorexia limits use of stimulants.
    MeSH term(s) Adolescent ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Attention Deficit Disorder with Hyperactivity/psychology ; Benzhydryl Compounds/adverse effects ; Benzhydryl Compounds/therapeutic use ; Central Nervous System Stimulants/adverse effects ; Central Nervous System Stimulants/therapeutic use ; Child ; Double-Blind Method ; Female ; Humans ; Male ; Modafinil ; Neuropsychological Tests ; Surveys and Questionnaires
    Chemical Substances Benzhydryl Compounds ; Central Nervous System Stimulants ; Modafinil (R3UK8X3U3D)
    Language English
    Publishing date 2003-08
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 639164-3
    ISSN 1873-5150 ; 0887-8994
    ISSN (online) 1873-5150
    ISSN 0887-8994
    DOI 10.1016/s0887-8994(03)00148-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  9. Article: Levetiracetam in autistic children: an open-label study.

    Rugino, Thomas A / Samsock, Teresa C

    Journal of developmental and behavioral pediatrics : JDBP

    2002  Volume 23, Issue 4, Page(s) 225–230

    Abstract: The objectives of this study were to determine whether autistic children taking levetiracetam (1) showed improvement in the areas of aggression, impulsivity, hyperkinesis, and mood instability, and (2) showed a nootropic response. Ten white autistic boys ...

    Abstract The objectives of this study were to determine whether autistic children taking levetiracetam (1) showed improvement in the areas of aggression, impulsivity, hyperkinesis, and mood instability, and (2) showed a nootropic response. Ten white autistic boys ranging from 4 to 10 years were compared pretreatment and while taking levetiracetam for an average of 4.1 weeks. Inattention, hyperkinesis, and impulsivity were evaluated using the Achenbach Attention Problems scale, Conners DSM-IV Total scale, and the Conners Attention-Deficit Hyperactivity Disorder Index scale, all of which showed statistically significant improvements. Mood instability was measured with the Conners Global Index (CGI) Emotional Lability and CGI Total scales, both of which showed statistically significant improvements. Aggressive behavior, as measured with the Achenbach Aggression scale, showed statistically significant improvement only for subjects who were not recently weaned from medications that reduce aggression (e.g., risperidone, carbamazepine, desipramine). Levetiracetam may reduce hyperactivity, impulsivity, mood instability, and aggression in autistic children with these problems. No nootropic effect was observed.
    MeSH term(s) Aggression ; Anticonvulsants/therapeutic use ; Autistic Disorder/drug therapy ; Autistic Disorder/psychology ; Cetirizine/therapeutic use ; Child ; Child Behavior Disorders/epidemiology ; Child Behavior Disorders/etiology ; Child, Preschool ; Disruptive, Impulse Control, and Conduct Disorders/epidemiology ; Disruptive, Impulse Control, and Conduct Disorders/etiology ; Drug Therapy, Combination ; Histamine H1 Antagonists/therapeutic use ; Humans ; Hyperkinesis/epidemiology ; Hyperkinesis/etiology ; Incidence ; Levetiracetam ; Male ; Nootropic Agents/therapeutic use ; Piracetam/analogs & derivatives ; Piracetam/therapeutic use ; Prospective Studies ; Surveys and Questionnaires ; Valproic Acid/therapeutic use
    Chemical Substances Anticonvulsants ; Histamine H1 Antagonists ; Nootropic Agents ; Levetiracetam (44YRR34555) ; Valproic Acid (614OI1Z5WI) ; Cetirizine (YO7261ME24) ; Piracetam (ZH516LNZ10)
    Language English
    Publishing date 2002-08-13
    Publishing country United States
    Document type Clinical Trial ; Comparative Study ; Journal Article
    ZDB-ID 603379-9
    ISSN 0196-206X
    ISSN 0196-206X
    DOI 10.1097/00004703-200208000-00006
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  10. Article ; Online: A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder.

    Wilens, Timothy E / Bukstein, Oscar / Brams, Matthew / Cutler, Andrew J / Childress, Ann / Rugino, Thomas / Lyne, Andrew / Grannis, Kara / Youcha, Sharon

    Journal of the American Academy of Child and Adolescent Psychiatry

    2012  Volume 51, Issue 1, Page(s) 74–85.e2

    Abstract: Objective: To examine efficacy, tolerability, and safety of guanfacine extended release (GXR; ≤4 mg/d) adjunctive to a long-acting psychostimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 ... ...

    Abstract Objective: To examine efficacy, tolerability, and safety of guanfacine extended release (GXR; ≤4 mg/d) adjunctive to a long-acting psychostimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years of age with suboptimal, but partial, response to psychostimulant alone.
    Method: In this multicenter, 9-week, double-blind, placebo-controlled, dose-optimization study, subjects (N = 461) continued their stable dose of psychostimulant given in the morning and were randomized to receive GXR in the morning (GXR AM), GXR in the evening (GXR PM), or placebo. Efficacy measures included ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events (AEs), vital signs, electrocardiograms, and laboratory evaluations.
    Results: At endpoint, GXR treatment groups showed significantly greater improvement from baseline ADHD-RS-IV total scores compared with placebo plus psychostimulant (GXR AM, p = .002; GXR PM, p < .001). Significant benefits of GXR treatment versus placebo plus psychostimulant were observed on the CGI-S (GXR AM, p = .013; GXR PM, p < .001) and CGI-I (GXR AM, p = .024; GXR PM, p = .003). At endpoint, small mean decreases in pulse, systolic, and diastolic blood pressure were observed in GXR treatment groups versus placebo plus psychostimulant. No new safety signals emerged following administration of GXR with psychostimulants versus psychostimulants alone. Most AEs were mild to moderate in severity.
    Conclusions: Morning or evening GXR administered adjunctively to a psychostimulant showed significantly greater improvement over placebo plus psychostimulant in ADHD symptoms and generated no new safety signals. Clinical trial registration information-Efficacy and Safety of SPD503 in Combination With Psychostimulants; http://www.clinicaltrials.gov; NCT00734578.
    MeSH term(s) Adolescent ; Adrenergic alpha-Agonists/administration & dosage ; Adrenergic alpha-Agonists/adverse effects ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Central Nervous System Stimulants/therapeutic use ; Child ; Delayed-Action Preparations ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Guanfacine/administration & dosage ; Guanfacine/adverse effects ; Humans ; Male ; Placebos ; Psychiatric Status Rating Scales ; Severity of Illness Index ; Treatment Outcome
    Chemical Substances Adrenergic alpha-Agonists ; Central Nervous System Stimulants ; Delayed-Action Preparations ; Placebos ; Guanfacine (30OMY4G3MK)
    Language English
    Publishing date 2012-01
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 392535-3
    ISSN 1527-5418 ; 0890-8567
    ISSN (online) 1527-5418
    ISSN 0890-8567
    DOI 10.1016/j.jaac.2011.10.012
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

To top