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| Name | Class |
|---|---|
| National Center for Research and Development, Poland | OTHER |
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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..
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPL500036 low dose | Experimental | Patients are to receive 20 mg of CPL500036 administered once dail for 28-days treatment period. |
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| CPL500036 high dose | Experimental | Patients are to receive 40 mg of CPL500036 administered once dail for 28-days treatment period. |
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| Placebo | Placebo Comparator | Patients are to receive placebo administered once dail for 28-days treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPL500036 - low dose | Drug | CPL500036 is to be oral administered. Each patient is to take 2 capsules with active substance and 2 capsules of placebo daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day -1, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotheraapy of Semmelweis University | Budapest | H-1083 | Hungary | |||
| Semmelweis University, Faculty of Medicine, Department of Psychiatry and Psychotherapy |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 5, 2025 | |
| Reset | Dec 19, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2024 | Sep 3, 2025 |
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| CPL500036 - high dose | Drug | CPL500036 is to be oral administered. Each patient is to take 4 capsules with active substance daily. |
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| Placebo | Drug | Placebo is to be oral administered. Each patient is to take 4 capsules of placebo daily. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | Day -1, Week 2 and 4 |
| Number of abnormal clinically significant values in vital signs (heart rate, blood pressure, respiratory rate) results. | 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. | up to 6 weeks |
| Number of abnormal clinically significant values in laboratory tests (hematologic, clinical chemistry, coagulation and urinalysis) results. | up to 6 weeks |
| Number of abnormal physical, neurological, ophthalmological and dermatological examination findings. | 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. | up to 6 weeks |
| Number of adverse events. | All adverse events that occurence during study will be assessed. | up to 6 weeks |
| CPL500036 Cmax - Maximum observed concentration | up to 24 hours after administration on Day 7 |
| CPL500036 Tmax - Time corresponding to occurrence of Cmax | up to 24 hours after administration on Day 7 |
| CPL500036 AUC (0-24h) - Area under the curve from time zero to 24 hours | up to 24 hours after administration on Day 7 |
| CPL500036 AUC T1/2 - Apparent terminal elimination half-life | up to 24 hours after administration on Day 7 |
| CPL500036 CL/F (Apparent clearance) and Vz/F (apparent volume of distribution during terminal phase) | up to 24 hours after administration on Day 7 |
| CPL500036 Cthrough - Concentration immediately prior to dosing | up to 24 hours after administration on Day 7 |
| Budapest |
| H-1085 |
| Hungary |
| Department of Psychiatry, Mental hygiene and Addictology of Petz Aladár County Teaching Hospital | Győr | H-9024 | Hungary |
| Bács-Kiskun County Teaching Hospital Kalocsa Holy Cross Hospital | Kalocsa | H-6300 | Hungary |
| Psychiatry Department of Tolna County Balassa Janos Hospital | Szekszárd | H-7100 | Hungary |
| Uniwersytecki Szpital Kliniczny | Bialystok | 15-272 | Poland |
| Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych | Bolesławiec | 59-700 | Poland |
| Samodzielny Publiczny Psychiatryczny Zakład Opieki Zdrowotnej | Choroszcz | 16-070 | Poland |
| Wojewódzki Szpital dla Psychicznie i Nerwowo Chorych | Gmina Świecie | 86-100 | Poland |
| Ivano-Frankivsk National Medical University, Department of Psychiatry, Narcology and Medical Psychology | Ivano-Frankivsk | 76014 | 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 |
| 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- commercial enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", | Lviv | 79021 | Ukraine |
| 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 |
| Vinnytsia National Medical University named after M.I. Pirogov, Department of Psychiatry, Narcology and Psychotherapy with a course of postgraduate education | Vinnytsia | 21018 | Ukraine |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2024 | Sep 3, 2025 | SAP_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 5, 2025 | Dec 19, 2025 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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