Status:
TERMINATED
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
Lead Sponsor:
AbbVie
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess how sa...
Detailed Description
Per the final protocol amendment 3, the number of dosing arms in the 6-week DBP of the study changed from 3 to 2. Participants enrolled in the study through Protocol Amendment 2 and who were randomize...
Eligibility Criteria
Inclusion
- Diagnosed with schizophrenia at least 1 year before informed consent.
- Experienced a persistent psychotic episode within 2 months prior to informed consent requiring treatment modifications as judged by the investigator or sub-investigator.
Exclusion
- \- History of clinically significant medical conditions or any other reason that the investigator (or subinvestigator) determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
Key Trial Info
Start Date :
August 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05368558
Start Date
August 18 2022
End Date
September 20 2024
Last Update
October 20 2025
Active Locations (52)
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1
Akita University Hospital /ID# 245941
Akita, Akita, Japan, 010-8543
2
International University of Health and Welfare Narita Hospital /ID# 243870
Narita-shi, Chiba, Japan, 2868520
3
Fukuoka University Hospital /ID# 244404
Fukuoka, Fukuoka, Japan, 814-0180
4
Kuramitsu Hospital /ID# 242511
Fukuoka, Fukuoka, Japan, 819-0037