SchizophreniaPhase 2NCT05278156
Efficacy, Safety and Pharmacokinetics Study of CPL500036 (PDE10A Inhibitor) in Patients With Schizophrenia
A Phase 2 study testing CPL500036 - low dose and CPL500036 - high dose in people with Schizophrenia, run by Celon Pharma SA at 16 sites in 3 countries.
Trial summary
The purpose of this study is to determine the efficacy, safety, tolerability and pharmacokinetics (PK) properties of CPL500036 compound (PDE10a inhibitor) in patients with an acute exacerbation of schizophrenia after 28 days of administration.. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CPL500036 - low dose and CPL500036 - high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 19 May 2021to 19 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has a primary diagnosis of schizophrenia confirmed by clinical interview [SCID-5-CT].
- Male or female patient aged 18 to 65, inclusive, at Screening.
- The patient's with exacerbation of psychotic symptoms
- The patient has a score of 5 or higher in 3 or more items of the following PANSS items at Screening and Baseline
- The patient has a PANSS Total Score of 80 or higher during Screening and on Baseline
- The patient of childbearing potential willing to use acceptable forms of contraception.
Show all 9Show fewer
- The patient has a score in CGI-S scale of 4 or greater at Screening and on Baseline
- 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.
- 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.
Who cannot join
- The patient has a decrease in the PANSS Total Score at Baseline compared with the Total Score at Screening.
- Patient who recently participated in another interventional clinical study with an Investigational Medicinal Product.
- The patient has uncontrolled abnormality which may impact the ability of the patient to participate or potentially confound the study results.
- The patient has a history of severe head injury, traumatic brain injury, myocardial infarction or stroke.
- The patient has a moderate or severe substance use disorder for alcohol or other substances of abuse except nicotine or caffeine.
- The patient is pregnant or lactating or intending to become pregnant or intending to donate ova.
Show all 14Show fewer
- 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.
- The patient is considered by the Investigator to be at imminent risk of suicide or injury to self or others.
- The patient has chronic movement disorder that may interfere with the interpretation of study results.
- The patient has any existing or previous history of cancer or has newly diagnosed diabetes.
- The patient has long QT syndrome or is under treatment with antiarrhythmic drugs.
- The patient is considered to be treatment resistant. .
- The patient has received electroconvulsive therapy.
- The patient has any laboratory values outside the normal range that are considered by the Investigator to be clinically significant at Screening.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Ukraine7 sites
Ivano-Frankivsk National Medical University, Department of Psychiatry, Narcology and Medical Psychology
Ivano-Frankivsk, 76014
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
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
Communal non-commercial enterprise of the Lviv Regional Council "Lviv Regional Clinical Psychoneurological Dispensary",
Lviv, 79017
Communal non- commercial enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital",
Lviv, 79021
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
Vinnytsia National Medical University named after M.I. Pirogov, Department of Psychiatry, Narcology and Psychotherapy with a course of postgraduate education
Vinnytsia, 21018
Hungary5 sites
Department of Psychiatry and Psychotheraapy of Semmelweis University
Budapest, H-1083
Semmelweis University, Faculty of Medicine, Department of Psychiatry and Psychotherapy
Budapest, H-1085
Department of Psychiatry, Mental hygiene and Addictology of Petz Aladár County Teaching Hospital
Győr, H-9024
Bács-Kiskun County Teaching Hospital Kalocsa Holy Cross Hospital
Kalocsa, H-6300
Psychiatry Department of Tolna County Balassa Janos Hospital
Szekszárd, H-7100
Poland4 sites
Uniwersytecki Szpital Kliniczny
Bialystok, 15-272
Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych
Bolesławiec, 59-700
Samodzielny Publiczny Psychiatryczny Zakład Opieki Zdrowotnej
Choroszcz, 16-070
Wojewódzki Szpital dla Psychicznie i Nerwowo Chorych
Gmina Świecie, 86-100
About this study
Official title: Phase II, Double Blind, Randomized, Placebo Controlled, Parallel Group, Trial to Explore Efficacy, Safety and Pharmacokinetics of CPL500036 (PDE10A Inhibitor) in Patients With an Acute Exacerbation of Schizophrenia
The purpose of this study is to determine the efficacy, safety, tolerability and pharmacokinetics (PK) properties of CPL500036 compound (PDE10a inhibitor) in patients with an acute exacerbation of schizophrenia after 28 days of administration..
Read the detailed description
This is a double-blind, randomized, placebo controlled, parallel group, dose ranging study to explore the efficacy, safety, tolerability and PK of 2 different doses of CPL500036 (phosphodiesterase 10A [PDE10A] inhibitor) in patients with an acute exacerbation of schizophrenia. Approximately 165 patients will be randomized at a 1:1:1 ratio and will be dosed with 20 mg CPL500036, 40 mg CPL500036 or placebo once daily for 28 consecutive days (Day 1 to Day 28). Patients will remain in house for the duration of the Treatment Period. The study will comprise of a Screening Period (that will include a prior Medication Washout Period), a Treatment Period and a Follow-up Period. After discharge from the Clinical Unit, patients will return to the Clinical Unit for 2 once weekly Follow-up Visits. Approximately 30% of the patients (17 patients in each of the 3 treatment groups) will undergo extensive PK sampling during the Treatment Period, and the remaining 70% of the patients will only undergo sparse PK sampling.
- Conditions
- Schizophrenia
- Being tested
- CPL500036 - low dose, CPL500036 - high dose, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPL500036 - low doseDrug
CPL500036 is to be oral administered. Each patient is to take 2 capsules with active substance and 2 capsules of placebo daily.
CPL500036 - high doseDrug
CPL500036 is to be oral administered. Each patient is to take 4 capsules with active substance daily.
PlaceboDrug
Placebo is to be oral administered. Each patient is to take 4 capsules of placebo daily.
| Study group | Role | What they receive |
|---|---|---|
| CPL500036 low dose | Experimental | Patients are to receive 20 mg of CPL500036 administered once dail for 28-days treatment period. Receives: Drug: CPL500036 - low dose |
| CPL500036 high dose | Experimental | Patients are to receive 40 mg of CPL500036 administered once dail for 28-days treatment period. Receives: Drug: CPL500036 - high dose |
| Placebo | Placebo comparator | Patients are to receive placebo administered once dail for 28-days treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PANSS positive subscale at Day 28.
The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient.Total score is 210 points. The higher PANSS total score, the more severe schizophrenia.
Measured: Day -1, Day 28
Secondary outcomes (21)
Change from baseline in PANSS positive subscale at Week 1, 2 and 3
The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient.Total score is 210 points. The higher PANSS total score, the more severe schizophrenia.
Measured: Day -1, Week 1, 2 and 3
Change from baseline in PANSS Total Score at Weeks 1, 2, 3, 4
The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient.Total score is 210 points. The higher PANSS total score, the more severe schizophrenia.
Measured: Day -1, Week 1, 2, 3 and 4
Change from Baseline in PANSS Subscales Using the Marder 5 factor Model at Weeks 1, 2, 3, and 4
The PANSS is a 30-item scale used to measure symptoms of schizophrenia.
Measured: Day -1, Week 1, 2, 3 and 4
Change from Baseline in PANSS Negative Subscales at Weeks 1, 2, 3 and 4
The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient.Total score is 210 points. The higher PANSS total score, the more severe schizophrenia.
Measured: Day -1, Week 1, 2, 3 and 4
Change from Baseline in PANSS general psychopathology Subscale at Weeks 1, 2, 3 and 4
The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient.Total score is 210 points. The higher PANSS total score, the more severe schizophrenia.
Measured: Day -1, Week 1, 2, 3 and 4
Percentage of Clinical Responders Based on the PANSS Total Score.
Clinical responder is defined as a ≥ 30% decrease from baseline.
Measured: Day -1, Week 1, 2, 3 and 4
Change from Baseline in Clinical Global Impression Severity (CGI-S) Score at Weeks 1, 2, 3, and 4
CGI-S scale is a physician-rated scale that is designed to rate the severity of the patient's illness at the time of assessment. It is a 7-point assessment where 1= normal (not at all ill) and 7 = among the most extremely ill patients.
Measured: Day -1, Week 1, 2, 3 and 4
Clinical Global Impression Scale Improvement (CGI-I) Score at Weeks 1, 2, 3, 4.
CGI-I is a 7 points scale that requires the clinician to assess how much the patient's illness has improved or worsened during treatment. It is a 7-point assessment where 1= Very much improved and 7 = Very much worse
Measured: Day -1, Week 1, 2, 3 and 4
Change from Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Score at Weeks 2 and 4.
BACS is specifically designed to measure treatment-related improvements in cognition. The BACS is a cognition assessment battery that assesses 6 domains of cognitive function found to be consistently impaired in schizophrenia: verbal memory, working memory, motor speed, attention, executive functions, and verbal fluency.
Measured: Day -1, Week 2 and 4
Number of abnormal clinically significant values in vital signs (heart rate, blood pressure, respiratory rate) results.
Measured: up to 6 weeks
Number of abnormal clinically significant findings in electrocardiogram results.
The following electrocardiogram parameters will be assess: PR interval, QRS interval, RR interval, QT interval and QTc interval.
Measured: up to 6 weeks
Number of abnormal clinically significant values in laboratory tests (hematologic, clinical chemistry, coagulation and urinalysis) results.
Measured: up to 6 weeks
Number of abnormal physical, neurological, ophthalmological and dermatological examination findings.
Measured: up to 6 weeks
Number and intensity of extrapyramidal side effects.
It will be assessed by using Extrapyramidal Symptom Rating Scale (ESRS). This scale is using to assess four types of drug-induced movement disorders (DIMD): Parkinsonism, akathisia, dystonia, and tardive dyskinesia.
Measured: up to 6 weeks
Number of adverse events.
All adverse events that occurence during study will be assessed.
Measured: up to 6 weeks
CPL500036 Cmax - Maximum observed concentration
Measured: up to 24 hours after administration on Day 7
CPL500036 Tmax - Time corresponding to occurrence of Cmax
Measured: up to 24 hours after administration on Day 7
CPL500036 AUC (0-24h) - Area under the curve from time zero to 24 hours
Measured: up to 24 hours after administration on Day 7
CPL500036 AUC T1/2 - Apparent terminal elimination half-life
Measured: up to 24 hours after administration on Day 7
CPL500036 CL/F (Apparent clearance) and Vz/F (apparent volume of distribution during terminal phase)
Measured: up to 24 hours after administration on Day 7
CPL500036 Cthrough - Concentration immediately prior to dosing
Measured: up to 24 hours after administration on Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start19 May 2021
- Primary completion5 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celon Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278156
- Sponsor's protocol ID
- 02PDE2019
- Status last verified
- Sep 2025
- First submitted
- 9 Feb 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wieczorek M, Waszkiewicz N, Gromniak-Haniecka E, Rethelyi JM, Pustovoyt M, Filts Y, Blazhevych Y, Matloka M, Janowska S, Lapinska B, Rudzki PJ, Jazwiec R, Sierzputowska-Prarat J. PDE10A Inhibition in Schizophrenia: A Randomised, Placebo-Controlled Phase 2 Study of Alofropodect (CPL'36) in Patients Experiencing Acute Schizophrenia. CNS Drugs. 2026 Jul 31. doi: 10.1007/s40263-026-01317-5. Online ahead of print.
PubMed 42533223
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Double Blind, Randomized, Placebo Controlled, Parallel Group, Trial to Explore Efficacy, Safety and Pharmacokinetics of CPL500036 (PDE10A Inhibitor) in Patients With an Acute Exacerbation of Schizophrenia
- ClinicalTrials.gov ID
- NCT05278156
- Acronym / sponsor ID
- 02PDE2019
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Celon Pharma SAIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 19 May 2021 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy, safety, tolerability and pharmacokinetics (PK) properties of CPL500036 compound (PDE10a inhibitor) in patients with an acute exacerbation of schizophrenia after 28 days of administration..
Detailed description
This is a double-blind, randomized, placebo controlled, parallel group, dose ranging study to explore the efficacy, safety, tolerability and PK of 2 different doses of CPL500036 (phosphodiesterase 10A [PDE10A] inhibitor) in patients with an acute exacerbation of schizophrenia. Approximately 165 patients will be randomized at a 1:1:1 ratio and will be dosed with 20 mg CPL500036, 40 mg CPL500036 or placebo once daily for 28 consecutive days (Day 1 to Day 28). Patients will remain in house for the duration of the Treatment Period. The study will comprise of a Screening Period (that will include a prior Medication Washout Period), a Treatment Period and a Follow-up Period. After discharge from the Clinical Unit, patients will return to the Clinical Unit for 2 once weekly Follow-up Visits. Approximately 30% of the patients (17 patients in each of the 3 treatment groups) will undergo extensive PK sampling during the Treatment Period, and the remaining 70% of the patients will only undergo sparse PK sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPL500036 low dose | Experimental | Drug: CPL500036 - low dosePatients are to receive 20 mg of CPL500036 administered once dail for 28-days treatment period. |
| CPL500036 high dose | Experimental | Drug: CPL500036 - high dosePatients are to receive 40 mg of CPL500036 administered once dail for 28-days treatment period. |
| Placebo | Placebo comparator | Drug: PlaceboPatients are to receive placebo administered once dail for 28-days treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient has a primary diagnosis of schizophrenia confirmed by clinical interview [SCID-5-CT].
- Male or female patient aged 18 to 65, inclusive, at Screening.
- The patient's with exacerbation of psychotic symptoms
- The patient has a score of 5 or higher in 3 or more items of the following PANSS items at Screening and Baseline
- The patient has a PANSS Total Score of 80 or higher during Screening and on Baseline
Key exclusion criteria (14 listed)
- The patient has a decrease in the PANSS Total Score at Baseline compared with the Total Score at Screening.
- Patient who recently participated in another interventional clinical study with an Investigational Medicinal Product.
- The patient has uncontrolled abnormality which may impact the ability of the patient to participate or potentially confound the study results.
- The patient has a history of severe head injury, traumatic brain injury, myocardial infarction or stroke.
- The patient has a moderate or severe substance use disorder for alcohol or other substances of abuse except nicotine or caffeine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPL500036 - low doseCPL500036 is to be oral administered. Each patient is to take 2 capsules with active substance and 2 capsules of placebo daily. | Drug | CPL500036 low dose |
| CPL500036 - high doseCPL500036 is to be oral administered. Each patient is to take 4 capsules with active substance daily. | Drug | CPL500036 high dose |
| PlaceboPlacebo is to be oral administered. Each patient is to take 4 capsules of placebo daily. | Drug | Placebo |
Primary outcome
Change from baseline in PANSS positive subscale at Day 28.
Time frame: Day -1, Day 28
The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient.Total score is 210 points. The higher PANSS total score, the more severe schizophrenia.
21 secondary outcomes
Change from baseline in PANSS positive subscale at Week 1, 2 and 3
Time frame: Day -1, Week 1, 2 and 3
Change from baseline in PANSS Total Score at Weeks 1, 2, 3, 4
Time frame: Day -1, Week 1, 2, 3 and 4
Change from Baseline in PANSS Subscales Using the Marder 5 factor Model at Weeks 1, 2, 3, and 4
Time frame: Day -1, Week 1, 2, 3 and 4
Change from Baseline in PANSS Negative Subscales at Weeks 1, 2, 3 and 4
Time frame: Day -1, Week 1, 2, 3 and 4
Change from Baseline in PANSS general psychopathology Subscale at Weeks 1, 2, 3 and 4
Time frame: Day -1, Week 1, 2, 3 and 4
Percentage of Clinical Responders Based on the PANSS Total Score.
Time frame: Day -1, Week 1, 2, 3 and 4
Change from Baseline in Clinical Global Impression Severity (CGI-S) Score at Weeks 1, 2, 3, and 4
Time frame: Day -1, Week 1, 2, 3 and 4
Clinical Global Impression Scale Improvement (CGI-I) Score at Weeks 1, 2, 3, 4.
Time frame: Day -1, Week 1, 2, 3 and 4
Change from Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Score at Weeks 2 and 4.
Time frame: Day -1, Week 2 and 4
Number of abnormal clinically significant values in vital signs (heart rate, blood pressure, respiratory rate) results.
Time frame: up to 6 weeks
Number of abnormal clinically significant findings in electrocardiogram results.
Time frame: up to 6 weeks
Number of abnormal clinically significant values in laboratory tests (hematologic, clinical chemistry, coagulation and urinalysis) results.
Time frame: up to 6 weeks
Number of abnormal physical, neurological, ophthalmological and dermatological examination findings.
Time frame: up to 6 weeks
Number and intensity of extrapyramidal side effects.
Time frame: up to 6 weeks
Number of adverse events.
Time frame: up to 6 weeks
CPL500036 Cmax - Maximum observed concentration
Time frame: up to 24 hours after administration on Day 7
CPL500036 Tmax - Time corresponding to occurrence of Cmax
Time frame: up to 24 hours after administration on Day 7
CPL500036 AUC (0-24h) - Area under the curve from time zero to 24 hours
Time frame: up to 24 hours after administration on Day 7
CPL500036 AUC T1/2 - Apparent terminal elimination half-life
Time frame: up to 24 hours after administration on Day 7
CPL500036 CL/F (Apparent clearance) and Vz/F (apparent volume of distribution during terminal phase)
Time frame: up to 24 hours after administration on Day 7
CPL500036 Cthrough - Concentration immediately prior to dosing
Time frame: up to 24 hours after administration on Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 42533223Wieczorek M, Waszkiewicz N, Gromniak-Haniecka E, Rethelyi JM, Pustovoyt M, Filts Y, Blazhevych Y, Matloka M, Janowska S, Lapinska B, Rudzki PJ, Jazwiec R, Sierzputowska-Prarat J. PDE10A Inhibition in Schizophrenia: A Randomised, Placebo-Controlled Phase 2 Study of Alofropodect (CPL'36) in Patients Experiencing Acute Schizophrenia. CNS Drugs. 2026 Jul 31. doi: 10.1007/s40263-026-01317-5. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPL500036 - low dose and CPL500036 - high dose in people with Schizophrenia, run by Celon Pharma SA at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Ukraine, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in PANSS positive subscale at Day 28. (time frame: Day -1, Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05278156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.