Phase 4 Schizophrenia Trial, Recruiting NCT06562608 Sponsor: Deepak K. Sarpal, M.D. Condition: Schizophrenia
Back to Schizophrenia

Phase 4 Schizophrenia Trial, Recruiting

NCT06562608
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:

For people with a psychiatric diagnosis:

  • You have been formally diagnosed with schizophrenia or schizoaffective disorder, confirmed through a structured medical interview
  • You have been prescribed the medication benztropine or trihexyphenidyl for at least 6 months
  • You are between 40 and 70 years old
  • You score 3 or higher on a specific scale that measures the anticholinergic effects of your medications (confirm with trial site)
  • You have mild or no movement-related side effects from your medication, as assessed by your care team
  • You are willing and able to give your informed consent to participate

For healthy volunteers (comparison group):

  • You are between 40 and 70 years old
  • You are willing and able to give your informed consent to participate

Who may not be able to join:

For people with a psychiatric diagnosis:

  • You are experiencing serious side effects from anticholinergic medications, such as fever or severely blurred vision, that require immediate removal of those medications
  • You have a serious neurological or medical condition affecting the brain, such as Parkinson's disease, dementia, multiple sclerosis, lupus, or a history of traumatic brain injury
  • You are considered to be at significant risk of harming yourself or others
  • You have difficulty with communication, understanding, or any other reason that would prevent you from giving informed consent
  • You have a medical device such as a pacemaker or anything else that makes MRI scanning unsafe for you
  • You currently have an active substance use disorder (however, if your substance use disorder is in remission, you may still be eligible — confirm with trial site)
  • You are currently receiving electroconvulsive therapy (ECT)

For healthy volunteers:

  • You have a history of psychotic illness or currently have an active psychiatric condition, as determined by a clinical interview
  • You score higher than 1 on a scale measuring the anticholinergic effects of medications (confirm with trial site)
  • You have anything that makes MRI scanning unsafe for you
  • You have a neurological condition, a serious non-psychiatric illness that could affect brain function, or an intellectual disability
  • You have a family history of psychosis
  • You are currently taking anticholinergic medications for any reason

⚠️ 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 27 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: Deepak K Sarpal, M.D., University of Pittsburgh

Phone: 4122465618

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
Sponsor
Deepak K. Sarpal, M.D.
Registry
ClinicalTrials.gov
Start date
1 February 2025
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in cognitive performance; Change in scores on quality of life assessments.; Change in scores on functional outcome assessments.; change in brain functional connectivity.; change in activation of neurocognitive networks; Brain glutamate concentration

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: 27 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