Attributions and Perception of Methylphenidate Effects in Adolescents With ADHD

Objective: Although a number of studies demonstrate that children with ADHD do not attribute their behavior to taking medication, it remains unstudied whether adolescents, who have a longer history of taking medication for ADHD, show performance attributions to medication. Method: A sample of 46 adolescents completed daily attributions for success or failure as a part of their participation in a summer treatment program with a double-blind, placebo-controlled assessment of methylphenidate. Results: Results demonstrated that adolescents with ADHD did not reliably discern active medication from placebo, rarely attributed their performance to the pill, and showed no differences in attributional style as a function of medication status. Conclusion: These data indicate that adolescents with ADHD may possess inaccurate beliefs about the effect of stimulant medication on their behavior.

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Differential Response to Methylphenidate in Inattentive and Combined Subtype ADHD

Journal of Attention Disorders ◽

10.1177/1087054712469256 ◽

2016 ◽

Vol 21 (1) ◽

pp. 62-70 ◽

Cited By ~ 6

Author(s):

Susan H. Beery ◽

Herbert C. Quay ◽

William E. Pelham

Keyword(s):

Problem Behaviors ◽

Treatment Program ◽

Verbal Abuse ◽

Effect Sizes ◽

Double Blind ◽

Children With Adhd ◽

Double Blind Placebo ◽

Summer Treatment Program ◽

Medication Effect ◽

Work Completion

Objective: To examine response to methylphenidate (MPH) assessed by direct observation of ecologically valid behaviors in boys with ADHD with high hyperactivity-impulsivity (HI) and those with predominantly inattentive symptoms (ADHD/I). Method: Sixty-three boys ages 7 to 13 participated in an ADHD Summer Treatment Program and received a double-blind placebo-controlled assessment of .3 mg/kg of MPH on problem behaviors and individualized behavior goals. Medication effect sizes were calculated for each child for each behavior. Results: Children with ADHD/HI ( n = 21) displayed larger MPH effect sizes for interrupting, verbal abuse, and compliance, and marginally greater response for teasing and counselor-directed goals. Children with ADHD/I ( n = 21) displayed small medication effect sizes ( ds < .20) for many behaviors often identified as primary deficits in this group (e.g., attention to activities, peer interaction, class work completion, and accuracy). Conclusion: Systematic medication assessment for ADHD/I that quantifies response in ecologically valid areas of functional impairment is essential.

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Children with ADHD and symptoms of oppositional defiant disorder improved in behavior when treated with methylphenidate and adjuvant risperidone, though weight gain was also observed – Results from a randomized, double-blind, placebo-controlled clinical trial

Psychiatry Research ◽

10.1016/j.psychres.2016.12.010 ◽

2017 ◽

Vol 251 ◽

pp. 182-191 ◽

Cited By ~ 10

Author(s):

Leila Jahangard ◽

Shahrokh Akbarian ◽

Mohammad Haghighi ◽

Mohammad Ahmadpanah ◽

Amir Keshavarzi ◽

...

Keyword(s):

Clinical Trial ◽

Weight Gain ◽

Oppositional Defiant Disorder ◽

Controlled Clinical Trial ◽

Double Blind ◽

Children With Adhd ◽

Double Blind Placebo ◽

Oppositional Defiant

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Efficacy of Galcanezumab for Migraine Prevention in Patients With a Medical History of Anxiety and/or Depression: A Post Hoc Analysis of the Phase 3, Randomized, Double‐Blind, Placebo‐Controlled REGAIN, and Pooled EVOLVE‐1 and EVOLVE‐2 Studies

Headache The Journal of Head and Face Pain ◽

10.1111/head.13970 ◽

2020 ◽

Vol 60 (10) ◽

pp. 2202-2219

Author(s):

Todd A. Smitherman ◽

Gretchen E. Tietjen ◽

Kory Schuh ◽

Vladimir Skljarevski ◽

Sarah Lipsius ◽

...

Keyword(s):

Medical History ◽

Migraine Prevention ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo ◽

Post Hoc Analysis ◽

History Of ◽

Post Hoc

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Double-blind, placebo-controlled study assessing the effect of chocolate consumption in subjects with a history of acne vulgaris

Journal of the American Academy of Dermatology ◽

10.1016/j.jaad.2012.12.061 ◽

2013 ◽

Vol 68 (4) ◽

pp. AB14

Keyword(s):

Acne Vulgaris ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

History Of

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A Double-Blind, Placebo-Controlled Study of Atomoxetine in Young Children With ADHD

Yearbook of Psychiatry and Applied Mental Health ◽

10.1016/j.ypsy.2011.08.096 ◽

2012 ◽

Vol 2012 ◽

pp. 46-47

Author(s):

A.H. Mack

Keyword(s):

Young Children ◽

Controlled Study ◽

Double Blind ◽

Children With Adhd ◽

Double Blind Placebo

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Effects of Piracetam as an Adjuvant Therapy on Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.59421 ◽

2021 ◽

Vol 15 (2) ◽

Author(s):

Kaveh Alavi ◽

Elham Shirazi ◽

Maryam Akbari ◽

Zahra Shahrivar ◽

Fatemeh-Sadat Noori ◽

...

Keyword(s):

Attention Deficit Hyperactivity Disorder ◽

Placebo Group ◽

Side Effects ◽

Adjuvant Therapy ◽

Attention Deficit ◽

Controlled Study ◽

Double Blind ◽

Children With Adhd ◽

Double Blind Placebo ◽

Hyperactivity Disorder

Background: Stimulants are highly effective in controlling symptoms of Attention-deficit/hyperactivity disorder (ADHD), but 30% of individuals with ADHD do not respond to them or cannot tolerate their side effects; thus, alternative treatment approaches need to be considered. Objectives: To evaluate the effect and safety of piracetam as an adjuvant therapy plus methylphenidate (MPH) in children with ADHD. Methods: Thirty-six children with ADHD (6-16 years old), admitted to three academic outpatient child psychiatric clinics in the second half of 2015, were randomly assigned to the “methylphenidate plus piracetam group” and the “methylphenidate plus placebo” group, in a double-blind, placebo-controlled study, for 6 weeks. The “Conner’s Parents’ Rating Scale-Revised (CPRS-R), Children Symptom Inventory-4 (CSI-4), Clinical Global Impression-Improvement scale (CGI-I), and Children’ Global Assessment Scale (CGAS) were completed at baseline and at the ends of the third and the sixth week, and the New York State Psychiatric Institute side effect forms were completed weekly, as outcome measures. Results: The level of improvement in CPRS-R, CSI-4, and CGI-I scales were significantly higher in the “methylphenidate plus piracetam” group compared with the “methylphenidate plus placebo” group. Side effects were not remarkable in any group. Conclusions: Piracetam as a short-term adjuvant treatment to methylphenidate can have considerable therapeutic effect and safety profile in children with ADHD and deserves further exploration to assess its potentialities in ADHD treatment.

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PROMISE: first-trimester progesterone therapy in women with a history of unexplained recurrent miscarriages – a randomised, double-blind, placebo-controlled, international multicentre trial and economic evaluation

Health Technology Assessment ◽

10.3310/hta20410 ◽

2016 ◽

Vol 20 (41) ◽

pp. 1-92 ◽

Cited By ~ 17

Author(s):

Arri Coomarasamy ◽

Helen Williams ◽

Ewa Truchanowicz ◽

Paul T Seed ◽

Rachel Small ◽

...

Keyword(s):

Economic Evaluation ◽

Cost Effectiveness ◽

Menstrual Cycle ◽

Luteal Phase ◽

Primary Outcome ◽

First Trimester ◽

Health Technology ◽

Double Blind ◽

Double Blind Placebo ◽

History Of

Background and objectivesProgesterone is essential to maintain a healthy pregnancy. Guidance from the Royal College of Obstetricians and Gynaecologists and a Cochrane review called for a definitive trial to test whether or not progesterone therapy in the first trimester could reduce the risk of miscarriage in women with a history of unexplained recurrent miscarriage (RM). The PROMISE trial was conducted to answer this question. A concurrent cost-effectiveness analysis was conducted.Design and settingA randomised, double-blind, placebo-controlled, international multicentre study, with economic evaluation, conducted in hospital settings across the UK (36 sites) and in the Netherlands (nine sites).Participants and interventionsWomen with unexplained RM (three or more first-trimester losses), aged between 18 and 39 years at randomisation, conceiving naturally and giving informed consent, received either micronised progesterone (Utrogestan®, Besins Healthcare) at a dose of 400 mg (two vaginal capsules of 200 mg) or placebo vaginal capsules twice daily, administered vaginally from soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) until 12 completed weeks of gestation (or earlier if the pregnancy ended before 12 weeks).Main outcome measuresLive birth beyond 24 completed weeks of gestation (primary outcome), clinical pregnancy at 6–8 weeks, ongoing pregnancy at 12 weeks, miscarriage, gestation at delivery, neonatal survival at 28 days of life, congenital abnormalities and resource use.MethodsParticipants were randomised after confirmation of pregnancy. Randomisation was performed online via a secure internet facility. Data were collected on four occasions of outcome assessment after randomisation, up to 28 days after birth.ResultsA total of 1568 participants were screened for eligibility. Of the 836 women randomised between 2010 and 2013, 404 received progesterone and 432 received placebo. The baseline data (age, body mass index, maternal ethnicity, smoking status and parity) of the participants were comparable in the two arms of the trial. The follow-up rate to primary outcome was 826 out of 836 (98.8%). The live birth rate in the progesterone group was 65.8% (262/398) and in the placebo group it was 63.3% (271/428), giving a relative risk of 1.04 (95% confidence interval 0.94 to 1.15;p = 0.45). There was no evidence of a significant difference between the groups for any of the secondary outcomes. Economic analysis suggested a favourable incremental cost-effectiveness ratio for decision-making but wide confidence intervals indicated a high level of uncertainty in the health benefits. Additional sensitivity analysis suggested the probability that progesterone would fall within the National Institute for Health and Care Excellence’s threshold of £20,000–30,000 per quality-adjusted life-year as between 0.7145 and 0.7341.ConclusionsThere is no evidence that first-trimester progesterone therapy improves outcomes in women with a history of unexplained RM.LimitationsThis study did not explore the effect of treatment with other progesterone preparations or treatment during the luteal phase of the menstrual cycle.Future workFuture research could explore the efficacy of progesterone supplementation administered during the luteal phase of the menstrual cycle in women attempting natural conception despite a history of RM.Trial registrationCurrent Controlled Trials ISRCTN92644181; EudraCT 2009-011208-42; Research Ethics Committee 09/H1208/44.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 41. See the NIHR Journals Library website for further project information.

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141 The Effects of Valbenazine on Tardive Dyskinesia: Subgroup Analyses of 3 Randomized, Double-Blind, Placebo-Controlled Trials

CNS Spectrums ◽

10.1017/s1092852918000366 ◽

2018 ◽

Vol 23 (1) ◽

pp. 88-88

Author(s):

Jonathan Meyer ◽

Gary Remington ◽

Ali Norbash ◽

Joshua Burke ◽

Scott Siegert ◽

...

Keyword(s):

Tardive Dyskinesia ◽

Involuntary Movement ◽

Controlled Trials ◽

Cyp2d6 Genotype ◽

Double Blind ◽

Double Blind Placebo ◽

Score Improvement ◽

Subgroup Analyses ◽

History Of ◽

Intent To Treat

AbstractStudy ObjectivesThe approval of valbenazine (INGREZZA; VBZ) for the treatment of tardive dyskinesia (TD) in adults was based on results from double-blind, placebo (PBO)-controlled trials. These studies demonstrated the efficacy of once-daily VBZ based on intent-to-treat analyses. However, because many different types ofpatients can develop TD, subgroup analyses describing treatment outcomes by various patient factors were also conducted.MethodsData were pooled from three 6-week trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), KINECT 3 (NCT02274558), with outcomes analyzed by VBZ dose (80 mg, 40 mg) and PBO. Descriptive analyses conducted using the Abnormal Involuntary Movement Scale (AIMS) total score included: mean change from baseline to Week 6; and AIMS response, defined as 50% improvement from baseline to Week 6. Subgroups were defined as follows: age (<55 years, ≥55 years), sex (male, female), psychiatric diagnosis (schizophrenia/schizoaffective disorder, mood disorder), CYP2D6 genotype (poor metabolizer [PM], non-PM), body mass index (BMI) (<18.5, 18.5 to <25, 25 to <30, ≥30 kg/m2), concomitant antipsychotic (yes, no); type of antipsychotic (atypical, typical/both); lifetime history of suicidality (yes, no); concomitant anticholinergic (yes, no); TD duration (<7 years, ≥7 years).ResultsThe pooled population included 373 participants (VBZ 80 mg, n=101; VBZ 40 mg, n=114; PBO, n=158). Mean improvements from baseline to Week 6 in AIMS total score were greater overall with VBZ compared to PBO. Within subgroup categories, AIMS score improvement with VBZ 80 mg (recommended dose) was greater in CYP2D6 PMs (n=17; 80 mg, -6.8; 40 mg, 2.4; PBO, 0.5), participants taking no concomitant antipsychotics (n=64; 80 mg, -4.9; 40 mg, -3.0; PBO, 0.0), and overweight participants (BMI 25 to <30 kg/m2, n=115; 80 mg, -4.2; 40 mg, 2.7; PBO, -0.7). Overweight participants also had the highest AIMS response rates at Week 6 (80 mg, 57.7%; 40 mg, 31.6%; PBO, 11.8%), followed by participants taking typical/both antipsychotics (n=67; 80 mg, 57.1%; 40 mg, 20.0%; PBO, 25.0%), and those taking anticholinergics (n=126; 80 mg, 52.9%; 40 mg, 22.7%; PBO, 6.3%).ConclusionThese preliminary analyses indicate that TD improvements were generally greater with VBZ than PBO across most subgroups. However, the small sizes of some subgroups may need to be considered when interpreting results. Additional analyses within subgroup categories are ongoing and will be presented at the meeting.Funding AcknowledgementsThis study was funded by Neurocrine Biosciences, Inc.

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