Phase 4 ADHD Trial, Recruiting NCT03781765 Sponsor: Icahn School of Medicine at Mount Sinai Condition: ADHD
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Phase 4 ADHD Trial, Recruiting

NCT03781765
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:

  • Children who are pre-pubescent (at an early stage of physical development, such as Tanner stage 1 or 2)
  • Children aged 7 to 12 years old (inclusive)
  • Children whose parent or guardian has signed a consent form, and where the child has also given their agreement to participate
  • Children whose parent communicates well enough in English to give informed consent and fill out assessment questionnaires
  • Children who have been identified as having ADHD based on a structured parent interview (a computerised diagnostic tool called the C-DISC)
  • Children whose ADHD symptoms score at a certain level on the ADHD Rating Scale-5, based on a parent interview
  • Children whose ADHD symptoms are rated by their teacher at 1.5 standard deviations above what is typical for their age and sex on a scale called the SNAP
  • Children who have been identified as having Conduct Disorder (CD), or severe Oppositional Defiant Disorder (ODD) with at least 2 additional Conduct Disorder symptoms, based on the C-DISC interview
  • Children whose ODD or CD symptoms are rated by both a parent and a teacher at 1.5 standard deviations above what is typical for their age and sex on the SNAP scale

Who may not be able to join:

  • Children with a significant neurological or medical illness
  • Children with a history of head injury
  • Children who were exposed to alcohol or drugs before birth
  • Children who have been diagnosed with certain other psychiatric conditions, such as schizophrenia, bipolar disorder, major depression, generalised anxiety, social phobia, Tourette's Disorder, PTSD, or autism spectrum disorder
  • Children who currently have thoughts of suicide, or who have previously attempted suicide
  • Children who score below 75 on a standardised intelligence assessment called the WASI
  • Children who have previously used or are currently using stimulant medications (note: prior or current use of non-stimulant medications may be permitted, but the child must have stopped taking any such medication at least 2 weeks before the study begins)
  • Children who currently use or have previously used alcohol or drugs (confirmed through a diagnostic interview and urine testing)
  • Children who have a psychological or medical condition that would prevent them from being safely or comfortably placed in a brain scanner — for example, claustrophobia or severe obesity
  • Children who have metal in their body that cannot be removed before scanning, such as braces or a metal plate
  • Children who have visual problems that could affect their ability to complete tasks during the study
  • Children who have entered puberty early (Tanner stage above 2), or who are pregnant

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 19 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: Jeffrey Newcorn, MD, Icahn School of Medicine at Mount Sinai

Phone: 212-241-8012

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
4 June 2019
Est. completion
25 September 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

fMRI Measure

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: 19 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