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..
Budapest H-1083, Hungary
Psychiatry Department of Tolna County Balassa Janos Hospital
Szekszárd H-7100, Hungary
Uniwersytecki Szpital Kliniczny
Białystok 15-272, Poland
Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych
Bolesławiec 59-700, Poland
Wojewódzki Szpital dla Psychicznie i Nerwowo Chorych
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
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.
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.
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.
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.
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Efficacy, Safety and Pharmacokinetics Study of CPL500036 (PDE10A Inhibitor) in Patients With Schizophrenia 0 reviewsWrite Your Review
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