CLINICAL TRIALS PROFILE FOR RITALIN

All Clinical Trials for Ritalin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00018863 ↗	Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)	Completed	National Institute of Mental Health (NIMH)	Phase 3	2001-04-01	This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).
NCT00018863 ↗	Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)	Completed	New York State Psychiatric Institute	Phase 3	2001-04-01	This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).
NCT00025779 ↗	Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders	Completed	National Institute of Mental Health (NIMH)	N/A	2001-10-01	This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).
NCT00129467 ↗	Methylphenidate for Depressed Cancer Patients Receiving Palliative Care	Completed	Oregon Health and Science University	N/A	2005-02-01	The purpose of this study is to determine whether methylphenidate is an effective treatment for depression and to document the safety and tolerability of methylphenidate in combination with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill, hospice and palliative care cancer patients. The investigators hypothesize that depressed hospice and palliative care patients will be more likely to have a 50% reduction in scores on a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared to those patients who are taking a placebo plus an SSRI.
NCT00129467 ↗	Methylphenidate for Depressed Cancer Patients Receiving Palliative Care	Completed	US Department of Veterans Affairs	N/A	2005-02-01	The purpose of this study is to determine whether methylphenidate is an effective treatment for depression and to document the safety and tolerability of methylphenidate in combination with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill, hospice and palliative care cancer patients. The investigators hypothesize that depressed hospice and palliative care patients will be more likely to have a 50% reduction in scores on a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared to those patients who are taking a placebo plus an SSRI.
NCT00129467 ↗	Methylphenidate for Depressed Cancer Patients Receiving Palliative Care	Completed	VA Office of Research and Development	N/A	2005-02-01	The purpose of this study is to determine whether methylphenidate is an effective treatment for depression and to document the safety and tolerability of methylphenidate in combination with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill, hospice and palliative care cancer patients. The investigators hypothesize that depressed hospice and palliative care patients will be more likely to have a 50% reduction in scores on a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared to those patients who are taking a placebo plus an SSRI.
NCT00136734 ↗	Methylphenidate Treatment for Cocaine Abuse and ADHD - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	1998-04-01	Many cocaine dependent individuals are also diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Methylphenidate (Ritalin) is currently approved to treat individuals diagnosed with ADHD. The purpose of this study is to determine the effectiveness of methylphenidate in treating ADHD symptoms in cocaine dependent individuals.

Clinical Trial Conditions for Ritalin

Condition Name

Condition Name for Ritalin
Intervention	Trials
Attention Deficit Hyperactivity Disorder	26
Healthy	11
Attention Deficit Disorder With Hyperactivity	7
Apathy	5

Condition MeSH

Condition MeSH for Ritalin
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	47
Hyperkinesis	35
Disease	24
Fatigue	9

Clinical Trial Locations for Ritalin

Trials by Country

Trials by Country for Ritalin
Location	Trials
United States	105
Israel	18
Canada	11
Netherlands	4
Switzerland	4

Trials by US State

Trials by US State for Ritalin
Location	Trials
California	13
Massachusetts	10
Texas	10
Maryland	9
Ohio	8

Clinical Trial Progress for Ritalin

Clinical Trial Phase

Clinical Trial Phase for Ritalin
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	14
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Ritalin
Clinical Trial Phase	Trials
Completed	67
Unknown status	20
Terminated	13

Clinical Trial Sponsors for Ritalin

Sponsor Name

Sponsor Name for Ritalin
Sponsor	Trials
National Institute of Mental Health (NIMH)	8
Massachusetts General Hospital	8
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for Ritalin
Sponsor	Trials
Other	164
NIH	23
Industry	15

Ritalin (Methylphenidate): Clinical Trials, Market Analysis, and Projections

Introduction

Ritalin, commonly known by its generic name methylphenidate, is a widely used medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This article delves into the current clinical trials, market analysis, and future projections for Ritalin.

Clinical Trials Update

Current Studies

Several clinical trials are ongoing or recently completed to further understand the effects and efficacy of methylphenidate. One notable trial involves studying how methylphenidate affects brain activity and chemicals in adults with ADHD using brain scans. The primary objectives include measuring the BOLD signal during response inhibition and glutamate levels in the anterior cingulate cortex[1].

Trial Design and Objectives

In this trial, participants are divided into two groups: one receiving methylphenidate first followed by a placebo, and the other receiving a placebo first followed by methylphenidate. The doses administered are 10mg or 15mg, with a washout period of one week between the treatments. This design helps in comparing the effects of methylphenidate against a placebo[1].

Side Effects and Safety

Data from a Phase 4 trial involving 267 patients highlighted common side effects of methylphenidate, including appetite loss (51%), insomnia (40%), irritability (29%), and others such as picking at skin, nail biting, and stomachache. Despite these side effects, the drug has already been approved by the FDA, and these trials aim to gather more data on its safety and efficacy[1].

Market Analysis

Global ADHD Market Size

The global ADHD market was estimated at USD 14.3 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 3.7% from 2024 to 2030. This growth is driven by the increasing prevalence of ADHD and rising awareness among healthcare professionals and patients[2].

Market Segmentation

The stimulant segment, which includes methylphenidate, accounted for 70.91% of the market share in 2023 due to its high prescription and usage rates. Key players in the ADHD market include Novartis AG, Eli Lilly and Company, and Johnson & Johnson Services, Inc.[2].

Regional Market Trends

The ADHD market in Germany holds a significant share, with Ritalin being the first choice of treatment prescribed in small doses (5-10mg) that are progressively increased. The Asia Pacific region is expected to grow at the fastest rate due to rising prevalence and government initiatives to improve treatment options for ADHD[2].

Market Projections

Growth and Decline

While the global ADHD market is expected to grow, the market across seven major markets (7MM) is forecasted to decline at a negative CAGR of 0.9% from $11.9 billion in 2022 to $10.9 billion in 2032. This decline is largely due to patent expiries and the increasing uptake of generic drugs[3].

Pipeline Agents

Four late-stage pipeline agents, including Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR, are expected to launch in the US market by 2026. These agents are anticipated to drive moderate market growth but may face challenges due to the perception that they do not offer significant improvements over existing treatments[3].

Impact of Generic Drugs

The launch of generic versions of drugs like lisdexamfetamine dimesylate is expected to significantly impact the market, making generic products more attractive and limiting the uptake of novel entrants. This trend is likely to continue, influencing the overall market value of ADHD treatments[3].

Regional Growth Drivers

Asia Pacific

The Asia Pacific region is growing rapidly, with a CAGR of 12.3% during the forecast period. Factors contributing to this growth include unmet needs, a large patient population, and the availability of lower-cost drugs. Improving economies and the expansion of healthcare insurance in countries like Malaysia, Thailand, and Vietnam are also driving this growth[5].

Latin America and Middle East & Africa

Latin America is expected to witness a prominent CAGR during the forecast period, while the Middle East and Africa are predicted to grow at a CAGR of 9.31%. These regions are seeing increased funding and private sector involvement, which is boosting the healthcare sector and driving the demand for ADHD treatments[5].

Key Takeaways

• Clinical Trials: Ongoing trials focus on understanding the brain activity and chemical changes associated with methylphenidate in ADHD patients.
• Market Size: The global ADHD market is projected to grow at a CAGR of 3.7% from 2024 to 2030, driven by increasing prevalence and awareness.
• Market Segmentation: Stimulants like methylphenidate dominate the market, but the launch of generics and pipeline agents may impact future growth.
• Regional Trends: The Asia Pacific region is expected to grow rapidly, while other regions like Latin America and the Middle East & Africa also show significant growth potential.

FAQs

What are the common side effects of methylphenidate?

Common side effects include appetite loss, insomnia, irritability, picking at skin, nail biting, and stomachache[1].

Which regions are expected to drive the growth of the ADHD market?

The Asia Pacific region is expected to grow at the fastest rate, followed by Latin America and the Middle East & Africa[2][5].

What is the impact of generic drugs on the ADHD market?

The launch of generic drugs is expected to limit the uptake of novel entrants and reduce the overall market value of ADHD treatments[3].

What are the key drivers of the ADHD market growth?

Increasing prevalence of ADHD, rising awareness among healthcare professionals and patients, and escalating healthcare expenditure are key drivers[2].

Are there any new pipeline agents expected to launch in the ADHD market?

Yes, four late-stage pipeline agents are expected to launch in the US market by 2026, targeting core ADHD symptoms[3].

Sources

1. WithPower: Methylphenidate for ADHD - Clinical Trials.
2. Grand View Research: Attention Deficit Hyperactivity Disorder Market Report, 2030.
3. Clinical Trials Arena: ADHD market forecast to decline by $1bn between 2022 and 2032.
4. Patsnap: Methylphenidate Hydrochloride - Drug Targets, Indications, Patents.
5. Market Data Forecast: ADHD Therapeutics Market Size, Share & Growth Report, 2032.

Last updated: 2025-01-02