Vortioxetine for attention deficit hyperactivity disorder in adults: A randomized, double-blind, placebo-controlled, proof-of-concept study

2019 ◽  
Vol 33 (4) ◽  
pp. 511-521 ◽  
Author(s):  
Joseph Biederman ◽  
Annika Lindsten ◽  
Lasse B Sluth ◽  
Maria Louise Petersen ◽  
Anders Ettrup ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Adult Adhd ◽  
Rating Scale ◽  
Stage I ◽  
Proof Of Concept ◽  
Double Blind ◽  
Patient Functioning ◽  
Concept Study ◽  
Hyperactivity Disorder

Background: Stimulants remain the mainstay of treatment for attention-deficit hyperactivity disorder (ADHD) but are often associated with insufficient response or poor tolerability, leading to many patients not wishing to be treated with controlled substances. Aims: This randomized, placebo-controlled, proof-of-concept study (NCT02327013) evaluated the efficacy of a multimodal antidepressant, vortioxetine, in the treatment of ADHD, using a two-stage sequential parallel comparison design. Methods: Patients aged 18–55 years with a diagnosis of ADHD (DSM-5) and a total score ⩾24 on the Adult ADHD Investigator Symptom Rating Scale (AISRS) were randomized in study stage I with a 1:1:3 ratio to six weeks of treatment with vortioxetine 10 or 20 mg/day, or placebo ( n = 227). In study stage II, placebo non-responders (AISRS total score reduction <30% from stage I baseline) were re-randomized with a 1:1:1 ratio to six weeks of vortioxetine 10 or 20 mg/day, or placebo ( n = 59). Results: Across the two study stages combined, ADHD symptoms improved by approximately eight AISRS points in all treatment groups, showing no difference from placebo for either dose of vortioxetine, the study thus failing to meet its primary endpoint. However, both doses of vortioxetine separated from placebo in improving overall patient functioning, as measured by the Sheehan Disability Scale. Conclusion: Studies are warranted to further investigate this suggested benefit of a multimodal antidepressant for patient functioning in ADHD while addressing issues of non-adherence and placebo response. The study confirmed vortioxetine 10 mg and 20 mg as generally well-tolerated.

Atomoxetine versus Methylphenidate in Paediatric Outpatients with Attention Deficit Hyperactivity Disorder: A Randomized, Double-Blind Comparison Trial

2007 ◽  
Vol 41 (3) ◽  
pp. 222-230 ◽  
Author(s):  
Yufeng Wang ◽  
Yi Zheng ◽  
Yasong Du ◽  
Dong H. Song ◽  
Yee-Jin Shin ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Rating Scale ◽  
Response Rates ◽  
Double Blind Study ◽  
Adhd Symptoms ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
End Point ◽  
Blind Comparison

Objective: To (i) test whether atomoxetine is non-inferior to methylphenidate in treating symptoms of attention deficit hyperactivity disorder (ADHD) in paediatric patients; and (ii) determine the tolerability of the two drugs. Method: This double-blind study was conducted in 6- to 16-year-old outpatients with ADHD (DSM-IV) in China, Korea and Mexico (January–October 2004). Patients were randomly assigned to once-daily atomoxetine (0.8–1.8 mg kg−1 day−1; n = 164) or twice-daily methylphenidate (0.2–0.6 mg kg−1 day−1; n = 166) for ∼8 weeks. Primary efficacy assessment was the comparison of response rates (≥40% reduction from baseline to end point in total score) on the Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and -Scored. Tolerability measures included, but were not limited to, the assessment of treatment-emergent adverse events (TEAEs) and weight. Results: Atomoxetine was non-inferior to methylphenidate in improving ADHD symptoms based on response rates (atomoxetine, 77.4%; methylphenidate, 81.5%; one-sided 95% lower confidence limit = −11.7%, p = 0.404). Treatment-emergent adverse effects experienced significantly more frequently in the atomoxetine group, compared with the methylphenidate group, included anorexia (37.2% vs. 25.3%; p = 0.024), nausea (20.1% vs. 10.2%; p = 0.014), somnolence (26.2% vs. 3.6%; p <0.001), dizziness (15.2% vs. 7.2%; p = 0.024) and vomiting (11.6% vs. 3.6%; p = 0.007), most of which were of mild or moderate severity. Atomoxetine-treated patients experienced a small but significantly greater mean weight loss from baseline to end point than methylphenidate-treated patients (−1.2 kg vs. −0.4 kg; p <0.001). Conclusions: This study suggests that atomoxetine is non-inferior to methylphenidate in the improvement of ADHD symptoms in paediatric outpatients. Although both of the drugs were well tolerated, atomoxetine was associated with a higher incidence of TEAEs than methylphenidate.

Incidence of Internet addiction in adult attention deficit hyperactivity disorder

2017 ◽  
Vol 41 (S1) ◽  
pp. S396-S397
Author(s):  
B. Tuzun Mutluer ◽  
T.G. Yener Orum ◽  
S. Sertcelik
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Internet Addiction ◽  
Attention Deficit ◽  
Internet Use ◽  
Adult Adhd ◽  
Rating Scale ◽  
Self Report ◽  
Adhd Symptoms ◽  
Hyperactivity Disorder ◽  
Dsm Iv

ObjectiveIn this study, it was aimed to determine the internet use properties of Adult Attention Deficit Hyperactivity Disorder (ADHD) patients who were followed-up at Haydarpasa Numune Research and Training Hospital, Psychiatry Department; ADHD Outpatient Clinic.MethodThirty participants who were diagnosed with adult ADHD aged between 18–31 years rated their ADHD symptoms in childhood retrospectively, using Wender Utah Rating Scale. Patients rated current adult ADHD symptoms with the Adult ADHD DSM-IV-Based Diagnostic Screening and Rating Scale (DSRS) and severity of symptoms measured by Adult ADHD Self-Report Scale (ASRS). Internet addiction (IA) was assessed with Young's Internet Addiction Scale (IAS). It was determined that, none of 30 Adult ADHD patients have been diagnosed with IA.29 of patient have moderate internet use although 1 of patients have risky internet use. The results revealed that total ASRS score (P = 0.020), total Adult ADHD DSM-IV-Based DSRS score (P = 0.036) and the Attention Deficit related properties subscale total score (P = 0.042) were significantly correlated with the IAS total score. Subscale of the self-report scales including; failing to finish schoolworks, chores, or duties at workplace, difficulty of following through on instructions (P = 0.017), restiveness; impaired inhibitory performance (P = 0.017), feeling not confident (P = 0.017), difficulty of managing time (P = 0.047), failing to give close attention to details or making careless mistakes (P = 0.037) are closely relevant to IAS total score.ResultIn conclusion, clinical features, which are characteristic of Adult ADHD could have same shared etiology with IA. Furthermore, ADHD patients are more likely to have an IA diagnosis. However, it was thought that this result had to be supported with studies including larger samples.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Diagnostic accuracy of a brief screening tool for attention deficit hyperactivity disorder in UK prison inmates

2016 ◽  
Vol 46 (7) ◽  
pp. 1449-1458 ◽  
Author(s):  
S. Young ◽  
R. A. González ◽  
L. Mutch ◽  
I. Mallet-Lambert ◽  
L. O'Rourke ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Diagnostic Accuracy ◽  
Attention Deficit ◽  
Adult Adhd ◽  
Screening Tool ◽  
Rating Scale ◽  
Diagnostic Interview ◽  
Prison Inmates ◽  
Hyperactivity Disorder ◽  
Brief Screening

BackgroundAttention deficit hyperactivity disorder (ADHD) is overrepresented in prison, making it imperative to identify a screening tool that can be quickly applied to efficiently detect the disorder. We explored the discrimination ability of a widely used ADHD screen, the Barkley Adult ADHD Rating Scale (BAARS-IV), against a clinical diagnostic interview. A brief version of the screen was then developed in order to simplify its use in the prison context, and maximize its diagnostic properties.MethodA cross-sectional study of 390 male prison inmates was performed in the UK, all participants were screened and interviewed via the Diagnostic Interview for ADHD in Adults 2.0 (DIVA-2).ResultsA total of 47 (12.1%) inmates screened positive for ADHD using the full BAARS-IV, and 96 (24.6%) were clinically diagnosed, for a sensitivity of 37.9 and a specificity of 96.3. Our models identified the six items that most predicted ADHD diagnosis, with adjusted odds ratios ranging from 2.66 to 4.58. Sensitivity, specificity and accuracy were 0.82, 0.84 and 0.84, respectively, for the developed brief scale, and 0.71, 0.85 and 0.81 for its validation. Weighted probability scores produced an area under the curve of 0.89 for development, and 0.82 for validation of the brief scale.ConclusionsThe original BAARS-IV performed poorly at identifying prison inmates with ADHD. Our developed brief scale substantially improved diagnostic accuracy. The brief screening instrument has great potential to be used as an accurate and resource-effective tool to screen young people and adults for likely ADHD in the criminal justice system.

Screening for attention deficit–hyperactivity disorder (ADHD) symptomatology in adult mental health clinics

2017 ◽  
Vol 35 (3) ◽  
pp. 193-201 ◽  
Author(s):  
D. Adamis ◽  
I. Graffeo ◽  
R. Kumar ◽  
D. Meagher ◽  
D. O’Neill ◽  
...  
Keyword(s):  
Mental Health ◽  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Adult Adhd ◽  
Rating Scale ◽  
Self Report ◽  
Mental Health Clinics ◽  
Hyperactivity Disorder ◽  
Adult Mental Health ◽  
Full Study

ObjectivesThis study estimates the symptomatology of attention deficit–hyperactivity disorder (ADHD) in adult mental health services (AMHS) outpatient clinics.MethodsAll consecutive patients attending any of the outpatients’ clinics in Sligo/Leitrim AMHS were invited to participate. Participants completed the Adult ADHD Self-Report Scale (ASRS) and the Wender Utah Rating Scale (WURS) self-report. Clinical notes were reviewed to identify those with a pre-existing ADHD diagnosis.ResultsFrom 822 attending the clinics, 62 did not meet inclusion criteria, 97 declined to participate and 29 had incomplete data in either of the screening scales, leaving 634 (77%) eligible for full study analysis. Mean age was 40.38 (s.d.: 12.85), and 326 (51.4%) were females. In total, 215 (33.9%) screened positive on the WURS for childhood onset ADHD and 219 (34.5%) participants scored positive on the ASRS. Applying a more stringent criteria of scoring above cut-offs on both scales, suggested 131 (20.7%) screened positive on both. Only three (2.3%) had a prior clinical diagnosis.ConclusionsThis preliminary study suggests the possibility of relatively higher rates of ADHD in a general AMHS than previously thought, however, given the possibility of overlapping symptoms with other major psychiatric disorders in adulthood and recall bias further research is needed before drawing firm conclusions.

scholarly journals Characteristics of ADHD Symptom Response/Remission in a Clinical Trial of Methylphenidate Extended Release

2019 ◽  
Vol 8 (4) ◽  
pp. 461 ◽  
Author(s):  
Margaret Weiss ◽  
Ann Childress ◽  
Earl Nordbrock ◽  
Akwete Adjei ◽  
Robert Kupper ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Extended Release ◽  
Rating Scale ◽  
Phase Iii ◽  
Open Label ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Percent Change

Clinical trials in attention-deficit/hyperactivity disorder (ADHD) have typically measured outcome using clinician ratings on the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) and the Clinical Global Impression-Improvement (CGI-I) scale. Remission has been defined as an endpoint score of less than or equal to 18 on the ADHD-RS-IV (or a mean score of 1). Responders have been defined as patients who achieve a CGI-I score of much or very much improved (1 or 2). There is a lack of agreement in the literature on what percent change in symptoms on the ADHD-RS-IV should be used to define improvement or remission. This study uses data from a clinical trial of a methylphenidate extended release (MPH-MLR; Aptensio XR®) phase III clinical trial to attempt to determine the percent change of symptoms that best corresponds with improvement and remission. Symptom remission at endpoint (ADHD-RS-IV total score ≤18) was most closely aligned with a ≥46% reduction in ADHD-RS-IV total score. Clinical improvement was most closely aligned with a ≥40% reduction in ADHD-RS-IV total score. The three different measures of outcome were strongly aligned during double blind and open label treatment, and were independent of subtype status. Our data suggest that at least 40% improvement in symptoms is needed to achieve a robust response at endpoint.

scholarly journals Long-Term Safety and Effectiveness of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder

CNS Spectrums ◽  
2009 ◽  
Vol 14 (10) ◽  
pp. 573-586 ◽  
Author(s):  
Richard Weisler ◽  
Joel Young ◽  
Greg Mattingly ◽  
Joseph Gao ◽  
Liza Squires ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Adverse Events ◽  
Attention Deficit ◽  
Rating Scale ◽  
Upper Respiratory Tract ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Double Blind ◽  
Hyperactivity Disorder

ABSTRACTObjective: To evaluate the long-term safety and effectiveness of lisdexamfetamine dimesylate (LDX) in the treatment of adults with attention-deficit/hyperactivity disorder (ADHD).Methods: Following a 4-week, placebo-controlled, double-blind trial, 349 adults with ADHD were enrolled into an open-label, single-arm study for up to 12 months. Treatment was initiated at 30 mg/day and titrated up to 70 mg/day at subsequent visits to achieve optimal effectiveness and tolerability. Safety assessments included adverse events inquiries, vital signs, and electrocardiograms while the primary effectiveness assessment was the ADHD Rating Scale (ADHD-RS) total score.Results: A total of 191 (54.7%) subjects completed the study. The most common treatment-emergent adverse events (TEAEs) were upper respiratory tract infection (21.8%), insomnia (19.5%), headache (17.2%), dry mouth (16.6%), decreased appetite (14.3%), and irritability (11.2%). Most TEAEs were mild to moderate in severity. At endpoint, small but statistically significant increases in pulse and blood pressure were noted. Significant improvements in mean ADHD-RS total scores were observed at week 1 and sustained throughout the study (P<.0001 at all postbaseline visits). At endpoint, the mean improvement from baseline ADHD-RS total score was 24.8 (P<.0001).Conclusions: LDX demonstrated a safety profile consistent with long-acting stimulant use and provided continued effectiveness in adults with ADHD for up to 12 months.

Clinical Response and Symptomatic Remission in Children Treated With Lisdexamfetamine Dimesylate for Attention-Deficit/Hyperactivity Disorder

CNS Spectrums ◽  
2010 ◽  
Vol 15 (9) ◽  
pp. 559-568 ◽  
Author(s):  
Robert L. Findling ◽  
Ben Adeyi ◽  
Gary Chen ◽  
Bryan Dirks ◽  
Thomas Babcock ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Clinical Response ◽  
Attention Deficit ◽  
Rating Scale ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Long Term Study ◽  
Symptomatic Remission

ABSTRACTObjective: To examine clinical response and symptomatic remission in two studies of lisdexamfetamine dimesylate (LDX) in children with attention-deficit/hyperactivity disorder (ADHD).Methods: In a 4-week, placebo-controlled, double-blind trial, children 6–12 years of age with ADHD received LDX (30–70 mg/day) or placebo. In an open-label trial, children from previous studies were titrated to optimal dose over 4 weeks and maintained up to 1 year. Primary and secondary efficacy assessments were the ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions-Improvement (CGI-I) scale, respectively. Clinical response was defined as ≥30% reduction in ADHD-RS-IV total score with a CGI-I rating of 1 or 2; symptomatic remission was defined by ADHD-RS-IV total score ≤18.Results: In the 4-week study (N=285), at any postdose assessment, 79.3% achieved response (median 13 days) and 67.1% achieved remission (median 22 days) with LDX versus 29.2% and 23.6% with placebo. In the long-term study (N=251), at any postdose assessment, 96.0% responded and 62.7% maintained response; 88.8% achieved remission and 46.4% maintained remission.Conclusion: Most children treated with LDX achieved clinical response and symptomatic remission at one time point; once achieved, almost half maintained remission.

Childhood attention deficit/hyperactivity disorder in adults with anxiety disorders

1999 ◽  
Vol 29 (3) ◽  
pp. 515-525 ◽  
Author(s):  
C. MANCINI ◽  
M. VAN AMERINGEN ◽  
J. M. OAKMAN ◽  
D. FIGUEIREDO
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Anxiety Disorders ◽  
Attention Deficit ◽  
Adult Adhd ◽  
Rating Scale ◽  
Structured Interview ◽  
Retrospective Diagnosis ◽  
Hyperactivity Disorder ◽  
Co Morbidity ◽  
Symptom Overlap

Background. Previous research has reported co-morbidity between attention deficit hyperactivity disorder (ADHD) and anxiety disorders. Interpretation of these findings is complicated by symptom overlap in the clinical presentation of the disorders. We estimate the prevalence of ADHD in both the current and childhood histories of adults with anxiety disorders, while taking symptom overlap into account. We also evaluate the utility of the Wender Utah Rating Scale (WURS) for retrospective reporting of ADHD.Methods. Consecutive admissions (N=149) to an anxiety disorders clinic were given a diagnostic and psychometric assessment. The WURS was administered to obtain a retrospective diagnosis of childhood ADHD. Twenty-nine of the 35 people surpassing the cut-off score on the WURS were given a structured interview of adult ADHD symptoms.Results. The WURS contains many ‘internalizing’ items that may inflate retrospective accounts of ADHD. After taking this into account, there is still a significantly higher prevalence of ADHD in the retrospective reports of adults with anxiety disorders (15%) than would be expected by chance (4%). Furthermore, of those who meet retrospective criteria for ADHD, 45% (13 of 29) continue to meet diagnostic criteria for ADHD as adults.Conclusions. The WURS may require considerable revision for use with clinical populations. In spite of these difficulties with retrospective assessment, available evidence indicates that ADHD is more prevalent in the histories of anxiety disordered patients than would be expected from base rates.

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