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Label indication COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies (14) ]. Limitations of Use The use of COTEMPLA XR-ODT is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and… FDA label
Also known as Methylphenidate HCl, Ritalin-SR, Ritalin, methylphenidate hydrochloride, Concerta, Concerta AG formulation, Concerta EG formulation
Methylphenidate · 5 trials · 8 indications
This measure is an 18-item scale initially developed as a method for measuring apathy resulting from brain-related pathology.
The CGIC is a systematic method, developed for the Alzheimer's disease (AD) setting to assess clinically significant change in a clinical trial as viewed by an independent, skilled, and experienced clinician and has been used as an outcome in Parkinson disease trials
Feasibility is measured by the participation rate (i.e., ratio of those who agree to participate to those approached).
Acceptability is captured by parent- and self-report ratings on the Acceptability of Intervention Measure (AIM).
Adherence is measured through weekly pill counts. The primary adherence outcome is the ratio of the number of pills taken to those dispersed.
| Arm | Type | Description |
|---|---|---|
| Treatment | ACTIVE_COMPARATOR | Methylphenidate 20 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Methylphenidate Treatment Group | EXPERIMENTAL | All participants in this single-arm pilot study will receive extended-release methylphenidate for 4 weeks. The intervention is designed to evaluate feasibility, acceptability, adherence, and safety of stimulant treatment in children and adolescents with sickle cell disease (SCD) and executive functioning deficits. |
| Name | Type | Description |
|---|---|---|
| methylphenidate | DRUG | - |
| methylphenidate hydrochloride | DRUG | - |
| CONCERTA (OROS methylphenidate hydrochloride) | DRUG | - |
| Psychosocial intervention | BEHAVIORAL | The counseling session, in which a trained study clinician will counsel the primary caregiver, will take place at each study visit and after the randomization visit. It will last approximately 20-30 minutes. Each counseling session will consist of the following elements: * Review and adjustment of the patient and caregiver supportive care plans * Emotional support and the opportunity to ventilate feelings * Counseling regarding specific caregiving skills * Assistance with problem-solving of specific issues that the caregiver brings to the sessions * Answers to questions regarding the educational materials The educational materials will consist of a copy of the book "The 36-Hour Day" by Nancy L. Mace and Peter V. Rabins. The caregiver also will be provided with 24-hour phone access to the study nurse or physician for assistance with crises that may arise after hours. |
| Extended-Release Methylphenidate | DRUG | Participants will receive a weight-based dose of extended-release methylphenidate (0.6 mg/kg/day), rounded to either 10 mg or 20 mg, taken orally once daily for 4 weeks. |
Inclusion Criteria: * Currently having a Major Depressive Disorder episode without psychotic features * Has had an inadequate response to at least one but not more than 3 antidepressants given for 4 weeks * Is currently treated with an antidepressant for the past 4 weeks * Has a Montgomery Asberg D...
Methylphenidate is a small molecule central nervous system stimulant studied for Attention Deficit Disorder With Hyperactivity, Major Depressive Disorder, and Parkinson Disease. It is also known as methylphenidate hydrochloride, methylphenidate HCl, Ritalin, and Ritalin-SR. Johnson & Johnson, ticker JNJ, is developing it, and it is in Phase 3 clinical development.
Methylphenidate is being studied as prolonged-release methylphenidate hydrochloride for adults with Attention Deficit Disorder With Hyperactivity. A Phase 3 trial, NCT00246220, evaluated its effectiveness and safety in 402 adult patients with ADHD. It is also under study for Major Depressive Disorder and Parkinson Disease, so its use in ADHD remains investigational.
Methylphenidate targets SLC6A3 and SLC6A2, which are dopamine and norepinephrine transporters. It acts as an inhibitor of these transporters. This target profile underlies its activity as a small molecule agent being studied across psychiatric and neurological conditions, including ADHD, Major Depressive Disorder, and Parkinson Disease.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of methylphenidate. The company is associated with the clinical development program covering the drug's studied indications, including Attention Deficit Disorder With Hyperactivity, Major Depressive Disorder, and Parkinson Disease.
Methylphenidate is in Phase 3 clinical development and is investigational. Its program includes Phase 3 trials in adults with Attention Deficit Disorder With Hyperactivity and in adults with Major Depressive Disorder, plus a Phase 2 trial in veterans with Parkinson Disease and apathy. It has not been described as approved for these studied uses.
Methylphenidate has been studied in NCT00246220, a completed Phase 3 trial of prolonged-release methylphenidate hydrochloride in 402 adults with ADHD, and NCT00246233, a completed Phase 3 trial of CONCERTA as add-on therapy in 145 adults with Major Depressive Disorder. NCT05669170 is a Phase 2 trial for apathy in veterans with Parkinson Disease.
Yes. Methylphenidate is also known as methylphenidate hydrochloride, methylphenidate HCl, Ritalin, and Ritalin-SR. These names refer to the same active drug, a small molecule inhibitor of SLC6A3 and SLC6A2 that Johnson & Johnson is developing for ADHD, Major Depressive Disorder, and Parkinson Disease.