Phase 3 Schizophrenia Trial, Recruiting NCT05184335 Sponsor: Reviva Pharmaceuticals Condition: Schizophrenia
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Phase 3 Schizophrenia Trial, Recruiting

NCT05184335
Recruiting Phase 3

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 male or female, between 18 and 65 years old
  • You are able to read, understand, and sign a consent form approved by an ethics committee before any screening begins
  • You have been diagnosed with schizophrenia

Who may not be able to join:

  • You have a history of not responding, or barely responding, to at least 2 different antipsychotic medications taken for 28 days or more at the highest dose you could tolerate
  • You have ever taken the medication clozapine
  • You have had electroconvulsive therapy (a treatment using electrical stimulation) for schizophrenia in the past 5 years
  • You have never previously been treated for schizophrenia
  • Your main diagnosis is something other than schizophrenia, or another condition is more responsible for your current symptoms
  • You have a current diagnosis of a psychotic disorder other than schizophrenia, or symptoms believed to be caused by substance misuse
  • You have had a moderate-to-severe problem with substance use (not including caffeine or nicotine) in the past 6 months
  • You have a history of traumatic brain injury causing ongoing thinking difficulties, Alzheimer's disease, dementia, or another long-term brain or nervous system condition
  • You have an intellectual disability that would make it difficult to take part in the study
  • You have a current primary diagnosis of another mental health condition, such as schizoaffective disorder, major depression, PTSD, OCD, bipolar episodes, panic disorder, or certain personality disorders (confirm with trial site)
  • You are currently taking antipsychotic medication within the screening period (at least 3 days before the study baseline and throughout the study)
  • You have taken certain medications within 28 days before the study starts, including MAO inhibitors, stimulants, or specific drugs that strongly affect how the body processes medications (confirm with trial site for the full list)
  • You have received a long-acting injectable antipsychotic medication within a certain timeframe before the study starts (confirm with trial site)
  • A urine drug test shows the presence of certain substances, such as amphetamines, cocaine, opiates, or others, at a level meeting criteria for moderate-to-severe misuse

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 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Reviva Pharma

Phone: +1 4085018881

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 3
Sponsor
Reviva Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
24 January 2022
Est. completion
1 February 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Double Blind Safety and Efficacy of Brilaroxazine (RP5063); Open label Safety and Efficacy of Brilaroxazine (RP5063)

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: 20 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