Phase
Condition
Tourette's Syndrome
Schizotypal Personality Disorder (Spd)
Mood Disorders
Treatment
N/AClinical Study ID
Ages 18-50 Both
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)criteria for a diagnosis of schizophrenia
Able to read, understand, and sign the informed consent form (ICF) indicating that heor she understands the purpose of and procedures required for the study and arewilling to participate in the study
Willing and able to fill out self-administered questionnaires
Willing and able to adhere to the prohibitions and restrictions specified in theprotocol
A woman of childbearing potential must have a negative urine pregnancy test atScreening and baseline
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assistedreproduction during the study and for 6 months after receiving the last dose of studydrug
Exclusion
Exclusion Criteria:
His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example,clinically notable hypothyroidism, organic brain disorder)
Experienced intolerable side effects during treatment with paliperidone palmitate 1-month formulation (PP1M)
Has a known hypersensitivity to paliperidone or risperidone
Has received any other long-acting injectable antipsychotic medication other thanPP1M within the last 4 months before the first injection of the study drugpaliperidone palmitate 3-month formulation (PP3M)
Has received clozapine during the last 3 months before the Screening visit
Is considered to be at imminent risk of suicide, even after clinical intervention
Has a serious unstable medical condition, including recent and present clinicallyrelevant laboratory abnormalities
Has a history or current symptoms of tardive dyskinesia or neuroleptic malignantsyndrome
Is a woman who is pregnant or breast-feeding, or planning to become pregnant whileenrolled in this study or within 6 months after the last dose of PP3M
Has participated in an investigational drug trial in the 30 days prior to theScreening visit or is currently enrolled in an investigational study
Has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder, majordepressive disorder, schizoaffective disorder, autistic disorder, or intellectualdisabilities and/or meets the DSM-5 definition of severe substance use disorder (except for nicotine and caffeine) within 6 months prior to screening; however,participants with mild or moderate substance use disorder, with the exception ofintravenous drug use, will be eligible for enrollment
Study Design
Study Description
Connect with a study center
Rijeka,
CroatiaSite Not Available
Split,
CroatiaSite Not Available
Zagreb,
CroatiaSite Not Available
Esbjerg,
DenmarkSite Not Available
Middelfart,
DenmarkSite Not Available
Clermont Ferrand,
FranceSite Not Available
Montpellier,
FranceSite Not Available
Paris,
FranceSite Not Available
Rennes,
FranceSite Not Available
Toulon,
FranceSite Not Available
Berlin,
GermanySite Not Available
Hamburg,
GermanySite Not Available
Stralsund,
GermanySite Not Available
Beer Yaakov,
IsraelSite Not Available
Emek Hefer,
IsraelSite Not Available
Ness Ziona,
IsraelSite Not Available
Petach Tikva,
IsraelSite Not Available
Ramat Gan,
IsraelSite Not Available
Gwangju,
Korea, Republic ofSite Not Available
Jeonju,
Korea, Republic ofSite Not Available
Seongnam,
Korea, Republic ofSite Not Available
Seoul,
Korea, Republic ofSite Not Available
Ipoh,
MalaysiaSite Not Available
Johor Bahru,
MalaysiaSite Not Available
Kuala Lumpur,
MalaysiaSite Not Available
Assen,
NetherlandsSite Not Available
Groningen,
NetherlandsSite Not Available
Moscow,
Russian FederationSite Not Available
St-Petersburg,
Russian FederationSite Not Available
Barcelona,
SpainSite Not Available
Bilbao,
SpainSite Not Available
Burgos,
SpainSite Not Available
Madrid,
SpainActive - Recruiting
Oviedo,
SpainSite Not Available
Sabadell,
SpainSite Not Available
Valencia,
SpainActive - Recruiting
New Taipei City,
TaiwanSite Not Available
Tainan,
TaiwanSite Not Available
Taoyuan,
TaiwanSite Not Available
Ankara,
TurkeySite Not Available
Bursa,
TurkeySite Not Available
Istanbul,
TurkeySite Not Available
Sakarya,
TurkeySite Not Available
Derby,
United KingdomSite Not Available
Edinburgh,
United KingdomSite Not Available
Reading,
United KingdomSite Not Available
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