Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
methylphenidate · 4 trials · 5 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
| Arm | Type | Description |
|---|---|---|
| Treatment | ACTIVE_COMPARATOR | Methylphenidate 20 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| 001 | EXPERIMENTAL | Methylphenidate HCl Period 1: One tablet oral 36 mg once daily single-dose on Day 1 Period 2: Three tablets oral 18 mg once daily single-dose on Day 1 Period 3: Two tablets oral 36 mg once daily single-dose on Day 1. (Each treatment period will be separated by 3-7 days) |
| Name | Type | Description |
|---|---|---|
| methylphenidate | DRUG | - |
| 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. |
| Methylphenidate HCl | DRUG | Period 1: One tablet, oral, 36 mg, once daily, single-dose on Day 1 |
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 being studied for use in Attention Deficit Disorder With Hyperactivity, Major Depressive Disorder, Parkinson Disease, and pharmacokinetic studies in healthy volunteers. It is an investigational drug in clinical development, with trials conducted by Johnson & Johnson.
Methylphenidate is a central nervous system stimulant. It is being studied for its effects on attention, depression, and apathy in Parkinson's disease. The specific molecular target is not disclosed in the available information.
Methylphenidate is being developed by Johnson & Johnson, a company traded under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and effectiveness across several indications.
Methylphenidate is in Phase 1 clinical development, according to the latest data. It has completed Phase 3 trials for Attention Deficit Disorder With Hyperactivity and Major Depressive Disorder, and a Phase 2 trial for Parkinson Disease is planned.
Methylphenidate has been studied in several clinical trials. NCT00246220 was a completed Phase 3 trial in adults with ADHD, NCT00246233 was a completed Phase 3 trial for Major Depressive Disorder, and NCT01118702 was a Phase 1 pharmacokinetic study in healthy volunteers. A Phase 2 trial, NCT05669170, is planned for apathy in Parkinson's disease.
Methylphenidate is the active ingredient in the brand-name drug CONCERTA. Clinical trials have evaluated both Methylphenidate and CONCERTA (methylphenidate hydrochloride) for conditions such as ADHD and Major Depressive Disorder.