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New pill aims to calm schizophrenia symptoms fast

NCT ID NCT05278156

Symptom relief Sponsor: Celon Pharma SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new drug called CPL500036 in 189 people having a sudden worsening of schizophrenia symptoms. Participants took either a low dose, high dose, or placebo for 28 days. The main goal was to see if the drug reduces symptoms like hallucinations and delusions better than a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CPL500036 (PDE10A inhibitor)
What this could lead to
If it works, this could point toward a new treatment option for acute schizophrenia symptoms.
What could go wrong
This is an early Phase 2 trial with only 189 people, so results may not apply broadly. The drug may not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

189 people

The number who actually took part.

Started

May 2021

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The patient has a primary diagnosis of schizophrenia confirmed by clinical interview \[SCID-5-CT\]. 2. Male or female patient aged 18 to 65, inclusive, at Screening. 3. The patient's with exacerbation of psychotic symptoms 4. The patient has a score of 5 or higher in 3 or more items of the following PANSS items at Screening and Baseline 5. The patient has a PANSS Total Score of 80 or higher during Screening and on Baseline 6. The patient of childbearing potential willing to use acceptable forms of contraception. 7. The patient has a score in CGI-S scale of 4 or greater at Screening and on Baseline 8. The patient is able to and agrees to remain off prior antipsychotic medication and all excluded medications as outlined in the protocol for the duration of the Treatment Period. 9. The patient is able to sign informed consent after receiving information about the trial and has the ability and willingness to comply with the requirements and restrictions of the study protocol. Exclusion Criteria: 1. The patient has a decrease in the PANSS Total Score at Baseline compared with the Total Score at Screening. 2. Patient who recently participated in another interventional clinical study with an Investigational Medicinal Product. 3. The patient has uncontrolled abnormality which may impact the ability of the patient to participate or potentially confound the study results. 4. The patient has a history of severe head injury, traumatic brain injury, myocardial infarction or stroke. 5. The patient has a moderate or severe substance use disorder for alcohol or other substances of abuse except nicotine or caffeine. 6. The patient is pregnant or lactating or intending to become pregnant or intending to donate ova. 7. The patient has a history of or known personality disorder or other psychiatric disorder that, in the opinion of the Investigator, would interfere with participation in the study. 8. The patient is considered by the Investigator to be at imminent risk of suicide or injury to self or others. 9. The patient has chronic movement disorder that may interfere with the interpretation of study results. 10. The patient has any existing or previous history of cancer or has newly diagnosed diabetes. 11. The patient has long QT syndrome or is under treatment with antiarrhythmic drugs. 12. The patient is considered to be treatment resistant. . 13. The patient has received electroconvulsive therapy. 14. The patient has any laboratory values outside the normal range that are considered by the Investigator to be clinically significant at Screening.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • Bács-Kiskun County Teaching Hospital Kalocsa Holy Cross Hospital

    Kalocsa, H-6300, Hungary

  • Communal non- commercial enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital",

    Lviv, 79021, Ukraine

  • Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association", women's department No. 2, men's department No. 10.

    Kyiv, 08631, Ukraine

  • Communal non-commercial enterprise of the Lviv Regional Council "Lviv Regional Clinical Psychoneurological Dispensary",

    Lviv, 79017, Ukraine

  • Communal non-profit enterprise "Clinical Hospital "PSYCHIATRY"" of the executive body of the Kyiv City Council (Kyiv City State Administration), Center for Primary Psychotic Episode and Modern Treatment Methods.

    Kyiv, 04080, Ukraine

  • Department of Psychiatry and Psychotheraapy of Semmelweis University

    Budapest, H-1083, Hungary

  • Department of Psychiatry, Mental hygiene and Addictology of Petz Aladár County Teaching Hospital

    Győr, H-9024, Hungary

  • Ivano-Frankivsk National Medical University, Department of Psychiatry, Narcology and Medical Psychology

    Ivano-Frankivsk, 76014, Ukraine

  • Psychiatry Department of Tolna County Balassa Janos Hospital

    Szekszárd, H-7100, Hungary

  • Samodzielny Publiczny Psychiatryczny Zakład Opieki Zdrowotnej

    Choroszcz, 16-070, Poland

  • Semmelweis University, Faculty of Medicine, Department of Psychiatry and Psychotherapy

    Budapest, H-1085, Hungary

  • Ternopil National Medical University named after I.Y. Gorbachevskiy of the Ministry of Health of Ukraine, Department of Psychiatry, Narcology and Medical Psychology

    Ternopil, 46001, Ukraine

  • Uniwersytecki Szpital Kliniczny

    Bialystok, 15-272, Poland

  • Vinnytsia National Medical University named after M.I. Pirogov, Department of Psychiatry, Narcology and Psychotherapy with a course of postgraduate education

    Vinnytsia, 21018, Ukraine

  • Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych

    Bolesławiec, 59-700, Poland

  • Wojewódzki Szpital dla Psychicznie i Nerwowo Chorych

    Gmina Świecie, 86-100, Poland

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