CLINICAL TRIALS PROFILE FOR RITALIN-SR

All Clinical Trials for RITALIN-SR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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).
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).

Clinical Trial Conditions for RITALIN-SR

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for RITALIN-SR

Trials by Country

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−

Trials by Country for RITALIN-SR
Location	Trials
United States	105
Israel	18
Canada	11
Switzerland	4
Netherlands	4

Trials by US State

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−

Trials by US State for RITALIN-SR
Location	Trials
California	13
Texas	10
Massachusetts	10
Maryland	9
Ohio	8

Clinical Trial Progress for RITALIN-SR

Clinical Trial Phase

Clinical Trial Phase for RITALIN-SR
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	14
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for RITALIN-SR
Clinical Trial Phase	Trials
Completed	67
Unknown status	20
Terminated	13

Clinical Trial Sponsors for RITALIN-SR

Sponsor Name

Sponsor Name for RITALIN-SR
Sponsor	Trials
National Institute of Mental Health (NIMH)	8
Massachusetts General Hospital	8
Shalvata Mental Health Center	6

Sponsor Type

Sponsor Type for RITALIN-SR
Sponsor	Trials
Other	164
NIH	23
Industry	15

Ritalin SR: Clinical Trials, Market Analysis, and Projections

Introduction

Ritalin SR, a sustained-release formulation of methylphenidate, is a widely used medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy and Safety Studies

Clinical trials for Ritalin SR have been conducted to evaluate its efficacy and safety in pediatric and adult populations. A key study involved children with ADHD aged 6 to 12 years, where Ritalin SR was administered in doses ranging from 10 to 40 mg per day. This study included a single-blind titration phase followed by a double-blind treatment phase. The results showed that Ritalin SR was effective in managing ADHD symptoms, with common adverse reactions including headache, insomnia, upper abdominal pain, decreased appetite, and anorexia[1].

Adverse Reactions

The clinical trials highlighted several adverse reactions associated with Ritalin SR. These include serious cardiovascular reactions, increases in blood pressure and heart rate, psychiatric adverse reactions, priapism, peripheral vasculopathy, and long-term suppression of growth. Nervousness and insomnia were among the most common adverse reactions, which could often be managed by adjusting the dosage or timing of the medication[1][5].

Market Analysis

Current Market Trends

The ADHD market, which includes Ritalin SR, is expected to decline at a negative compound annual growth rate (CAGR) of 0.9% from $11.9 billion in 2022 to $10.9 billion in 2032 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). This decline is primarily driven by patent expiries and the anticipated launch of generic versions of key ADHD medications, including lisdexamfetamine dimesylate[2].

Impact of Generic Launches

The launch of generic versions of ADHD medications is expected to significantly impact the market for Ritalin SR. Generic products are often preferred due to their lower cost, which can limit the uptake of novel, more expensive innovator products. Despite the forecasted decline, the growing awareness of adult ADHD is expected to increase the total treated cases, potentially stabilizing some market segments[2].

Pipeline Agents

Several pipeline agents are expected to launch in the US market by 2026, including Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR. These agents are forecasted to drive moderate market growth but are not expected to show significant improvements in efficacy over currently marketed products. Instead, they will differentiate themselves through increased duration of action and reduced side effects[2].

Market Projections

Global Methylphenidate Market

The global methylphenidate market, which includes Ritalin SR, is expected to register a high CAGR over the forecast period. This growth is driven by the increasing use of methylphenidate in treating ADHD and narcolepsy, as well as its mood-stabilizing benefits. The market is also influenced by the growing prevalence of mental health disorders and the impact of social media and online education on attention spans, particularly among children and teenagers[3].

Regional Market Dynamics

The Europe region is expected to account for a significant revenue CAGR due to increasing medical research, the presence of large pharmaceutical companies, and robust healthcare facilities. In the US, the diagnosis of adult ADHD is increasing, which may sustain the demand for methylphenidate products like Ritalin SR despite the overall market decline[3].

Key Factors Influencing Market Growth

Increasing Diagnosis of ADHD

The growing awareness and diagnosis of ADHD, especially in adults, are expected to increase the number of treated cases. This trend is likely to support the demand for ADHD medications, including Ritalin SR, despite the broader market decline[2][3].

Competition from Generics

The launch of generic versions of ADHD medications will continue to be a significant factor influencing the market. Generic products are often more cost-effective, making them attractive alternatives to branded products like Ritalin SR[2].

Pipeline Innovations

While new pipeline agents are expected to enter the market, their impact may be limited by the perception that they do not offer significant improvements over existing treatments. These new agents will need to differentiate themselves through other benefits such as longer duration of action or reduced side effects[2].

Conclusion

Ritalin SR remains a crucial medication in the treatment of ADHD and narcolepsy, despite the challenges posed by the broader market trends. The decline in the ADHD market value, driven by patent expiries and generic launches, will likely affect the sales of Ritalin SR. However, the increasing diagnosis of ADHD, particularly in adults, and the ongoing need for effective treatments will continue to support the demand for this medication.

Key Takeaways

• Ritalin SR has been shown to be effective in clinical trials for treating ADHD in children.
• The ADHD market is expected to decline due to patent expiries and generic launches.
• Growing awareness of adult ADHD may sustain demand for methylphenidate products.
• New pipeline agents will focus on differentiation through duration of action and side effect profiles.
• Generic versions of ADHD medications will continue to impact the market.

FAQs

What are the common adverse reactions associated with Ritalin SR?

Common adverse reactions include headache, insomnia, upper abdominal pain, decreased appetite, and anorexia. Serious reactions can include cardiovascular issues, psychiatric adverse reactions, and long-term suppression of growth[1][5].

How is the ADHD market expected to change in the coming years?

The ADHD market is forecasted to decline at a negative CAGR of 0.9% from 2022 to 2032 due to patent expiries and the launch of generic products[2].

What new pipeline agents are expected to enter the ADHD market?

Pipeline agents include Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR, expected to launch in the US by 2026[2].

How does the increasing diagnosis of adult ADHD impact the market for Ritalin SR?

The growing awareness and diagnosis of adult ADHD are expected to increase the number of treated cases, potentially stabilizing the demand for methylphenidate products like Ritalin SR despite the overall market decline[2][3].

Why are generic versions of ADHD medications gaining traction?

Generic versions are preferred due to their lower cost, making them more attractive alternatives to branded products like Ritalin SR, especially after the initial promotion incentives for new products are withdrawn[2].

Sources

1. Novartis: RITALIN LA® [PDF].
2. Clinical Trials Arena: ADHD market forecast to decline by $1bn between 2022 and 2032.
3. Reports and Data: Methylphenidate Market Size, Share, Opportunities, Forecast 2030.
4. Health.mil: DOD Pharmacy and Therapeutics Committee Recommendations [PDF].
5. FDA: Ritalin Ritalin-SR [PDF].