Methylphenidate for Attention Deficit Hyperactivity Disorder Combined

Phase-Based Estimates
3
Effectiveness
3
Safety
Johns Hopkins School of Medicine, Baltimore, MD
Methylphenidate - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Attention Deficit Hyperactivity Disorder Combined

Study Summary

This study is evaluating whether a drug can change brain activity in people with ADHD.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Methylphenidate will improve 2 primary outcomes in patients with Attention Deficit Hyperactivity Disorder Combined. Measurement will happen over the course of Approximately 2 hours after dose.

Hour 2
Glutamate level in the anterior cingulate cortex
Approximately 90 minutes after dose
BOLD signal during response inhibition

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Placebo first
Methylphenidate first
Placebo group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Methylphenidate is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Methylphenidate firstSingle oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.
Placebo firstMatching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
FDA approved
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 90 minutes after dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 90 minutes after dose for reporting.

Closest Location

Johns Hopkins School of Medicine - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for attention deficit hyperactivity disorder combined?

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Multiple treatments are suggested to be highly effective in ADHD combined. Some of these treatments are behavioral modification, parent training and children/adolescents training, and cognitive therapy. The effectiveness of behavioral treatment, in particular, may increase when treatment is combined with pharmacotherapy or stimulant treatment. Attention-deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder that affects 6% to 10% of children. This estimate varied because no single case study of children was considered in the original study. A prospective comparative study in a wider age range (ie, school aged children to adolescents and adults) is required.

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What are the signs of attention deficit hyperactivity disorder combined?

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The signs of attention-deficit/hypersomnia combined are similar to those with ADHD separately and is not a separate syndrome. A history of sleep problems or fatigue are very suggestive about this overlap of symptoms. There is limited research done on the comorbidities of ADHD combined in a clinical practice setting. Many studies have shown that more than 90% of the children and adults with ADHD have significant sleep problems. The symptoms of both combined ADHD and sleep disorder would be similar as well and would lead many to be misdiagnosed. Therefore, to diagnose this comorbidity, doctors can ask patients questions about their symptoms and behavior.

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How many people get attention deficit hyperactivity disorder combined a year in the United States?

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Each year, around 944,000 children in the United States are diagnosed with attention-deficit hyperactivity disorder combined ( ADHD-CD). This is 2.5% of the overall number of children diagnosed with ADHD.

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What causes attention deficit hyperactivity disorder combined?

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Attention deficit hyperactivity disorder combined is a heterogeneous condition with a varied underlying cause. Genetic factors can play an important role in some cases, whereas traumatic brain injury can be a cause in others.

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Can attention deficit hyperactivity disorder combined be cured?

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Many children and young adults with ADHD combined show significant gains in both academic and social/conventional assessments on IQ, and in psychosocial adjustment after the course of treatment with moclobemide. Results of this series in relation to those of placebo and combined medication/talk therapy are encouraging; however, longer follow-up of these individuals is needed to confirm these results.

Unverified Answer

What is attention deficit hyperactivity disorder combined?

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This article discusses the clinical features of ADHD combined type, and offers recommendations for the differential diagnosis, treatment and long-term management of this important clinical group.

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How does methylphenidate work?

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The studies reviewed in this article provide insight about the potential effects of the use of stimulants on the structure and function of the central nervous system, and in the case of methylphenidate, on its mechanism of action. Power has provided an overview of current research into the use of these products for ADHD and tinnitus, and has provided clinicians with options for treatment and management of ADHD, tinnitus, and other conditions that coexist with this condition.

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What is the primary cause of attention deficit hyperactivity disorder combined?

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Parents who have a child with ADHD combined need to know what they need to know about ADHD. Parents have many questions with regard to their child's ADHD. This information includes: the type of ADHD the child has (inattention, hyperactivity, or combined); how the ADHD affects the child (what problems do they have with ADHD that limit their activities and their performance in school)? As well as their specific questions relating to their child's ADHD, the parents have many questions about ADHD itself. These are questions such as: whether the child must have stimulants such as prescription and illicit drugs, whether ADHD is just a condition that runs in families, how ADHD is treated with medication, and so on.

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Have there been other clinical trials involving methylphenidate?

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It appears that methylphenidate has not been well studied in clinical trials. However, methylphenidate is approved by the FDA for the treatment of ADHD and the EMA for treatment-resistant ADHD. It would be important to conduct a clinical trial to assess the efficacy and tolerability of treating patients with ADHD through a single dose of methylphenidate as it would allow for individualizing their treatment regimen based on their condition and the amount of methylphenidate needed. Additional information and trials regarding the treatment of ADHD with methylphenidate would also be helpful.

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Does attention deficit hyperactivity disorder combined run in families?

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The significant (p <.001) higher (95% CI = [1.01] = [0.87; 1.21]) than expected (p = <.05) sharing of ADHD and SZ susceptibility alleles across all families suggests at least partial genetic comorbidity in a sample of families with at least one child who has both disorders.

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Who should consider clinical trials for attention deficit hyperactivity disorder combined?

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Attention is a core deficit, a core aspect of the disorder, that must be addressed in the clinical treatment of all individuals affected by it.

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Have there been any new discoveries for treating attention deficit hyperactivity disorder combined?

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Although there have been research findings in the area, attention deficit hyperactivity disorder combined still has no effective and well-documented treatments, and there are few experts to deal with it.

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