Phase
Condition
Schizotypal Personality Disorder (Spd)
Tourette's Syndrome
Psychosis
Treatment
CPL500036 - low dose
CPL500036 - high dose
Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 PANSSitems 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 ofcontraception.
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 andall excluded medications as outlined in the protocol for the duration of theTreatment Period.
The patient is able to sign informed consent after receiving information about thetrial and has the ability and willingness to comply with the requirements andrestrictions of the study protocol.
Exclusion
Exclusion Criteria:
The patient has a decrease in the PANSS Total Score at Baseline compared with theTotal Score at Screening.
Patient who recently participated in another interventional clinical study with anInvestigational Medicinal Product.
The patient has uncontrolled abnormality which may impact the ability of the patientto participate or potentially confound the study results.
The patient has a history of severe head injury, traumatic brain injury, myocardialinfarction or stroke.
The patient has a moderate or severe substance use disorder for alcohol or othersubstances of abuse except nicotine or caffeine.
The patient is pregnant or lactating or intending to become pregnant or intending todonate ova.
The patient has a history of or known personality disorder or other psychiatricdisorder that, in the opinion of the Investigator, would interfere withparticipation in the study.
The patient is considered by the Investigator to be at imminent risk of suicide orinjury to self or others.
The patient has chronic movement disorder that may interfere with the interpretationof study results.
The patient has any existing or previous history of cancer or has newly diagnoseddiabetes.
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 consideredby the Investigator to be clinically significant at Screening.
Study Design
Study Description
Connect with a study center
Department of Psychiatry and Psychotheraapy of Semmelweis University
Budapest, H-1083
HungarySite Not Available
Semmelweis University, Faculty of Medicine, Department of Psychiatry and Psychotherapy
Budapest, H-1085
HungarySite Not Available
Department of Psychiatry and Psychotheraapy of Semmelweis University
Budapest 3054643, H-1083
HungarySite Not Available
Semmelweis University, Faculty of Medicine, Department of Psychiatry and Psychotherapy
Budapest 3054643, H-1085
HungarySite Not Available
Department of Psychiatry, Mental hygiene and Addictology of Petz Aladár County Teaching Hospital
Győr, H-9024
HungarySite Not Available
Department of Psychiatry, Mental hygiene and Addictology of Petz Aladár County Teaching Hospital
Győr 3052009, H-9024
HungarySite Not Available
Bács-Kiskun County Teaching Hospital Kalocsa Holy Cross Hospital
Kalocsa, H-6300
HungarySite Not Available
Bács-Kiskun County Teaching Hospital Kalocsa Holy Cross Hospital
Kalocsa 3050719, H-6300
HungarySite Not Available
Psychiatry Department of Tolna County Balassa Janos Hospital
Szekszárd, H-7100
HungarySite Not Available
Psychiatry Department of Tolna County Balassa Janos Hospital
Szekszárd 3044760, H-7100
HungarySite Not Available
Uniwersytecki Szpital Kliniczny
Bialystok 776069, 15-272
PolandSite Not Available
Uniwersytecki Szpital Kliniczny
Białystok, 15-272
PolandSite Not Available
Szpital dla Nerwowo i Psychicznie Chorych
Bolesławiec, 59-700
PolandActive - Recruiting
Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych
Bolesławiec, 59-700
PolandSite Not Available
Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych
Bolesławiec 3102987, 59-700
PolandSite Not Available
Samodzielny Publiczny Psychiatryczny Zakład Opieki Zdrowotnej
Choroszcz, 16-070
PolandSite Not Available
Samodzielny Publiczny Psychiatryczny Zakład Opieki Zdrowotnej
Choroszcz 774393, 16-070
PolandSite Not Available
Wojewódzki Szpital dla Psychicznie i Nerwowo Chorych
Gmina Świecie 3084074, 86-100
PolandSite Not Available
Szpital Neuropsychiatryczny, Samodzielny Publiczny Zakład Opieki Zdrowotnej
Lublin, 20-442
PolandSite Not Available
Klinika Psychiatrii Dorosłych Uniwersytetu Medycznego w Poznaniu
Poznań, 60-572
PolandSite Not Available
Specjalistyczny Psychiatryczny Zespół Opieki Zdrowotnej
Łódź, 91-229
PolandSite Not Available
Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych
Świecie, 86-100
PolandActive - Recruiting
Wojewódzki Szpital dla Psychicznie i Nerwowo Chorych
Świecie, 86-100
PolandSite Not Available
Ivano-Frankivsk National Medical University, Department of Psychiatry, Narcology and Medical Psychology
Ivano-Frankivsk, 76014
UkraineSite Not Available
Ivano-Frankivsk National Medical University, Department of Psychiatry, Narcology and Medical Psychology
Ivano-Frankivsk 707471, 76014
UkraineSite Not Available
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
UkraineSite Not Available
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
UkraineSite Not Available
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 703448, 08631
UkraineSite Not Available
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 703448, 04080
UkraineSite Not Available
Communal non- commercial enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital",
Lviv, 79021
UkraineSite Not Available
Communal non-commercial enterprise of the Lviv Regional Council "Lviv Regional Clinical Psychoneurological Dispensary",
Lviv, 79017
UkraineSite Not Available
Communal non- commercial enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital",
Lviv 702550, 79021
UkraineSite Not Available
Communal non-commercial enterprise of the Lviv Regional Council "Lviv Regional Clinical Psychoneurological Dispensary",
Lviv 702550, 79017
UkraineSite Not Available
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
UkraineSite Not Available
Ternopil National Medical University named after I.Y. Gorbachevskiy of the Ministry of Health of Ukraine, Department of Psychiatry, Narcology and Medical Psychology
Ternopil 691650, 46001
UkraineSite Not Available
Vinnytsia National Medical University named after M.I. Pirogov, Department of Psychiatry, Narcology and Psychotherapy with a course of postgraduate education
Vinnytsia, 21018
UkraineSite Not Available
Vinnytsia National Medical University named after M.I. Pirogov, Department of Psychiatry, Narcology and Psychotherapy with a course of postgraduate education
Vinnytsia 689558, 21018
UkraineSite Not Available

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