CLINICAL TRIALS PROFILE FOR RITALIN-SR

All Clinical Trials for Ritalin-sr

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-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	48
Hyperkinesis	35
Disease	24
Fatigue	9

Clinical Trial Locations for Ritalin-sr

Trials by Country

Trials by Country for Ritalin-sr
Location	Trials
United States	106
Israel	19
Canada	11
Switzerland	4
Netherlands	4

Trials by US State

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
PHASE2	1
Phase 4	37
Phase 3	14

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
Massachusetts General Hospital	8
National Institute of Mental Health (NIMH)	8
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for Ritalin-sr
Sponsor	Trials
Other	165
NIH	23
Industry	16

Ritalin-SR Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is Ritalin-SR and how is it positioned commercially?

Ritalin-SR is the sustained-release (SR) formulation of methylphenidate, a central nervous system stimulant indicated for attention-deficit/hyperactivity disorder (ADHD) in approved jurisdictions. In the market context, Ritalin-SR sits in the methylphenidate stimulant class and competes against both (1) other methylphenidate formulations (IR, ER, OROS-type ER) and (2) amphetamine-based stimulants (IR and ER) within ADHD.

Competitive implication for investors and R&D planners

• Formulation differentiation drives share: SR/ER release profiles affect dose frequency, tolerability, and adherence.
• Class-level regulation caps upside: all stimulants face similar controlled-substance requirements and prescriber monitoring, compressing “brand-new modality” premium.

What is the clinical-trials status for Ritalin-SR specifically?

No reliable, complete clinical-trials update specific to “Ritalin-SR” (as a unique product with a distinct identifier across registries) can be produced from the provided information. A product-name-only query typically fragments results across:

• branded vs generic labels,
• IR vs SR vs ER versions,
• country-specific dossiers and local registry naming.

Per operational constraint, a complete and accurate R&D and trial update cannot be issued without a definitive mapping from “Ritalin-SR” to specific registrational product codes and trial identifiers.

What does the available evidence say about methylphenidate SR/ER market dynamics?

Even without a product-specific trial map, the ADHD stimulant market has well-characterized structural drivers:

• Stable prevalence and chronic use: ADHD is a long-duration condition for a large share of treated patients, supporting repeat use once patients respond.
• Titration and switching churn: patients often cycle between formulations to manage onset/duration, appetite suppression, sleep effects, and school-day coverage.
• Payer incentives favor fewer dosing events: ER/SR formulations usually win formulary access where payers prioritize reduced dosing complexity and adherence.
• Patent and exclusivity structure shapes pricing power: brand SR products generally face generic erosion after expiry; enduring brands rely on lifecycle reformulations (or market-specific bundles).

How big is the methylphenidate/ADHD stimulant opportunity and what can be projected?

A projection for “Ritalin-SR” specifically requires product-level revenue mapping (market share, country mix, pricing net of rebates, and dosing share between SR and other ERs/IRs). That granularity is not available in the provided context, so a product-specific forecast cannot be built without violating the accuracy requirement.

What are the most actionable market levers to evaluate for Ritalin-SR?

1) Formulation share within methylphenidate

• Track share of patients on SR/ER vs IR.
• Watch payer policies that restrict multiple claims per day, which can shift patients toward ER/SR schedules.

2) Safety and tolerability outcomes that drive retention

• Appetite and weight monitoring programs
• Sleep disturbance management strategies
• Cardiovascular screening protocols adherence rates

3) Competitive intensity from amphetamine ER brands

• Amphetamine ER products often maintain strong formulary presence.
• Any SR brand’s growth hinges on demonstrable adherence or coverage advantages versus competing ERs.

4) Supply and compliance controls

• Controlled-substance compliance capability at scale
• Pharmacy substitution outcomes (generic vs brand switching rates)

What should investors model for “Ritalin-SR” under a generic erosion scenario?

Because SR methylphenidate brands typically face generic competition over time, the base-case commercial model generally trends toward:

• lower net price after generic entries, and
• defensive volume retention only if the SR dosing profile keeps a measurable segment of patients on-brand.

A high-integrity model would separate:

• gross-to-net contraction due to rebates and payer concessions,
• volume loss due to therapeutic substitution to equivalent generic methylphenidate SR,
• volume stabilization where SR-specific dosing tolerability matters.

Key Takeaways

• Clinical-trials update for Ritalin-SR specifically cannot be completed accurately from the provided information because product naming fragments across IR/SR/ER and registries.
• Market positioning is driven by SR/ER adherence and coverage, payer formulary placement, and stimulant-class switching.
• Product-specific revenue projection is not possible without product-level revenue share, pricing, and country mix, which are not provided here.

FAQs

1. Is “Ritalin-SR” the same as other Ritalin sustained-release products in trials?
   No. Trial datasets often label by formulation and registry naming conventions; product identity must be mapped to exact trial entries.

2. What drives SR methylphenidate share versus IR?
   Dosing convenience, school-day coverage, adherence, and formulary rules that prefer fewer dosing events.

3. How does generic erosion typically affect branded SR stimulants?
   Net price declines after generic entry and volume can shift to therapeutically equivalent generics, limiting long-term revenue growth unless retention advantages persist.

4. Do amphetamine ER products materially change the outlook for methylphenidate SR?
   They increase competitive intensity for payer formularies and prescriber preferences, often compressing growth unless a clear coverage or tolerability edge exists.

5. What is the fastest way to evaluate Ritalin-SR commercial viability?
   Build a product-level model using SR share of methylphenidate, gross-to-net assumptions, and retention under generic switching, then benchmark against amphetamine ER payer tiering.

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References

[1] FDA. Drug Safety and Availability Information. (FDA.gov). https://www.fda.gov/drugs/drug-safety-and-availability
[2] ClinicalTrials.gov. Search results for methylphenidate sustained-release. https://clinicaltrials.gov/