Phase
Condition
Tourette's Syndrome
Psychosis
Drugs
Treatment
N/AClinical Study ID
Ages 19-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria
Subjects who voluntarily consented to participating in the clinical trial.
Male and female legally aged ≥19 and < 65 years.
Subjects who were diagnosed of schizophrenia as defined by DSM diagnostic criteria, and were diagnosed of schizophrenia for at least for 2 years prior to screening.
Subjects with all of the following schizophrenia clinical features:
A. Outpatient subjects, with no hospitalization for worsening of schizophrenia within 3 months prior to screening.
B. Subjects who have no more than a moderate rating on the PANSS total score≤80 C. 4 individual PANSS items, which are concerning to psychotic symptom (P2. conceptual disorganization, P3. hallucinatory behavior, P6. suspiciousness/persecution, G9. unusual thought content), score≤4.
D. CGI-S score ≤4 (moderately ill).
Subjects who take atypical antipsychotic drugs with the therapeutic effective dose (as specified in each label) for schizophrenia treatment, and should be maintained on the type and dose of the current antipsychotic drugs (including both typical and atypical antipsychotic drugs) for at least 4 weeks prior to the screening.
Subjects who need antipsychotic treatment (other than clozapine), and would be stable when switching to Abilify Maintena on the investigator's judgement.
Subjects must exhibit willingness, physiologic capability, and an educational level sufficient to comply with all protocol procedures as per the investigator's judgment.
Exclusion criteria
Subject who showed medically significant adverse events or intolerance with aripiprazole during screening period or as prior experiences.
Subjects with a current DSM diagnostic criteria-based diagnosis other than schizophrenia, including Schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, neurocognitive disorder due to Alzheimer's or similar diseases, amnesia, borderline, paranoid, histrionic, schizotypal, schizoid, antisocial or other cognitive or personality disorders.
Subjects with diseases of the central nervous system that may impact the assessment of the psychotic symptoms as per investigator's opinion.
Subjects who have been treated with clozapine, electroconvulsive therapy (ECT) or other long-acting injectable antipsychotic drugs within 3 months prior to the screening.
Subjects who have been treated more than 2 oral antipsychotic drugs (including both typical and atypical antipsychotic drugs) with the minimum therapeutic effective dose (as specified in each label) for schizophrenia treatment at screening.
(e.g. Aripiprazole≥10 mg/day, Olanzapine≥10 mg/day, Risperidone≥2 mg/day, Quetiapine ≥150 mg/day)
- Subjects who have been treated with oral antipsychotic drugs (including both typical and atypical antipsychotic drugs) exceeding maximum maintenance dose (as specified in each label) at screening.
(e.g. Aripiprazole>30 mg/day, Olanzapine>20 mg/day, Risperidone > 6 mg/day, Quetiapine > 750 mg/day)
Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
Subjects had a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose them to undue risk or interfere with study assessments.
Significant history of drug abuse disorder (excluding caffeine and nicotine, including alcohol, as defined in DSM-5 substance use disorder or in the opinion of the investigator) within the last 6 months prior to screening.
Subjects who participated in another interventional clinical trial within 30 days prior to screening.
Pregnant or lactating women, or women of childbearing potential who are not willing to or not able to use contraceptive methods (sexual abstinence; oral, implanted or injection hormone contraceptive methods; intrauterine device or condom; barrier contraceptive methods such as diaphragm and spermicide), accepted to avoid pregnancy until the end of the clinical trial.
Subjects having any other clinically significant finding of the physical examination or laboratory value that make investigator consider that it would be inappropriate to participate in this study.
Study Design
Study Description
Connect with a study center
Konkuk University Chungju Hospital
Chungju, Chungcheongbuk-do 27376
Korea, Republic ofSite Not Available
Gongju National Hospital
Gongju, Chungcheongnam-do 32601
Korea, Republic ofSite Not Available
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do
Korea, Republic ofSite Not Available
Cha Bundang Medical Center
Seongnam-si, Gyeonggi-do
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si,, Gyeonggi-do
Korea, Republic ofSite Not Available
The Catholic University of Korea Uijeongbu ST. Mary'S Hospital
Uijeongbu Si, Gyeonggi-do
Korea, Republic ofSite Not Available
Yong-In Mental Hospital
Yongin-si, Gyeonggi-do 17089
Korea, Republic ofSite Not Available
Jeju National University Hospital
Jeju, Jeju-do 63241
Korea, Republic ofSite Not Available
Chonbuk National University Hospital
Jeonju, Jeollabuk-do
Korea, Republic ofSite Not Available
Keimyung University Dongsan Medical Center
Daegu,
Korea, Republic ofSite Not Available
Kyungpook National University Hospital
Daegu,
Korea, Republic ofSite Not Available
Yeungnam University Medical Center
Daegu,
Korea, Republic ofSite Not Available
Chungnam National University Hospital
Daejeon,
Korea, Republic ofSite Not Available
Eulji University Hospital
Daejeon, 35233
Korea, Republic ofSite Not Available
Konyang University Hospital
Daejeon, 35365
Korea, Republic ofSite Not Available
Chonnam National University Hospital
Gwangju,
Korea, Republic ofSite Not Available
Inha University Hospital
Incheon, 22332
Korea, Republic ofSite Not Available
International St. Mary's Hospital
Incheon,
Korea, Republic ofSite Not Available
Inje University Haeundae Paik Hospital
Pusan,
Korea, Republic ofSite Not Available
Pusan National University Yangsan Hospital
Pusan,
Korea, Republic ofSite Not Available
Eulji General Hospital
Seoul,
Korea, Republic ofSite Not Available
Ewha Womans University Mokdong Hospital
Seoul,
Korea, Republic ofSite Not Available
Kangbuk Samsung Hospital
Seoul, 03181
Korea, Republic ofSite Not Available
Korea University Anam Hospital
Seoul,
Korea, Republic ofSite Not Available
Kyung Hee University Hospital
Seoul,
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hosipital
Seoul,
Korea, Republic ofSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.