Phase 4 ADHD Trial, Recruiting NCT06577779 Sponsor: NYU Langone Health Condition: ADHD
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Phase 4 ADHD Trial, Recruiting

NCT06577779
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 60 years old (inclusive)
  • You are able to read and sign a consent form agreeing to take part
  • You are of any gender
  • You have been officially diagnosed with ADHD (specifically the inattentive or combined type), confirmed through a structured clinical interview
  • If you are not currently taking ADHD medication, your ADHD symptom score on a standard rating scale must reach a certain level at screening; if you were recently on ADHD medication, a slightly lower score is acceptable (confirm with trial site)
  • You have a diagnosis of dysthymia (persistent low mood) or an anxiety disorder that is currently in remission and has been stable on the same psychiatric medication for at least three weeks — and you must keep that medication the same throughout the study
  • You have not used any stimulant medication in the past 2 months
  • You use marijuana occasionally (fewer than 3 times per week) during the screening period only — once enrolled, you must agree not to use marijuana for the rest of the study
  • You do not use any illegal substances at screening or during the study

Who may not be able to join:

  • You have a known allergy or sensitivity to methylphenidate (the study drug) or any of its ingredients
  • You are currently taking or have taken a type of antidepressant called an MAOI (monoamine oxidase inhibitor) within the past 14 days
  • You have ever been diagnosed with bipolar disorder, a psychotic disorder, autism, or an intellectual disability
  • You have had active thoughts of suicide in the past year, or have made a suicide attempt in the past 2 years
  • You have a history of severe dependence on any drug (as assessed by a standard psychiatric interview)
  • You have used substances (other than occasional marijuana use as described above) within the past 6 months
  • You are currently taking any prescribed benzodiazepine (a type of anti-anxiety or sleep medication)
  • You have any unstable medical or neurological condition, or a significant heart or nervous system condition
  • You are currently taking certain psychiatric medications including mood stabilizers, antipsychotics, or hallucinogens (note: stable doses of antidepressants or anti-anxiety medications may be allowed — confirm with trial site)
  • You have previously tried methylphenidate and it did not work for you
  • You have a history of an allergic reaction to methylphenidate
  • You are a woman who is pregnant, breastfeeding, planning to become pregnant, or a man planning to father a child during the study or within one month after the study ends
  • The study doctor may exclude you based on their clinical judgment (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Lenard Adler, MD, NYU Langone Health

Phone: 646-754-4841

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
29 January 2025
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3; Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 10

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov