The purpose of this study is to compare the patient satisfaction between continued
administration of previous antipsychotics versus switched administration to paliperidone ER
in non-satisfied patients with previous (paliperidone)
Drug: Paliperdidone ER
Drug: Aripiprazole, olanzapine and risperidone (Antipsychotics)
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Locations near you
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Full eligibility criteria for NCT01592201
Ages eligible for Study
20 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
Must be diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
Have taken atypical antipsychotics (aripiprazole, olanzapine, risperidone) at least 6 weeks prior to start of study.
Have Medication Satisfaction Questionnaire (MSQ) score of ≤3
Competent patients who manage to answer the questionnaires
Have had a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
Have had relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity
(BMI≥40), or other systemic disease
Had received two or more different kind of antipsychotics.
Had a history of taking paliperidone extended release (ER).
Allergy or hypersensitivity to risperidone or paliperidone ER.
Have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months.
Have had Medication Satisfaction Questionnaire (MSQ) score>3
Have been hospitalized for longer than 8 continuous weeks during the past 6 months
Had history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
Current substance dependence (DSM-IV) or past history of dependence (more than 6 months)
All locations for NCT01592201
Korea, Republic of (9)
Busan, Korea, Republic of
Cheonan City, Korea, Republic of
Chuncheon-Si, Korea, Republic of
Chungju-Si, Korea, Republic of
Dae-Gu, Korea, Republic of
Daejeon, Korea, Republic of
Goyang-Si, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Seoul, Korea, Republic of
View full eligibility
Tris trial is registered with FDA with number: NCT01592201. The sponsor of the trial is Janssen Korea, Ltd., Korea and it is looking for 13 volunteers for the current phase.
Official trial title: An Open-label, Prospective, Randomized and Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
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