Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia

JRCT ID: jRCT2031220096

Registered date:28/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Schizophrenia
• Date of first enrollment: 01/09/2022
• Target sample size: 250
• Countries of recruitment: Taiwan,Japan
• Study type: Interventional

Intervention(s)

Cariprazine Dose A, Dose B, or Placebo.
Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose A or Dose B or Dose C for 18 weeks.

Outcome(s)

• Primary Outcome: Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Total Score

Secondary Outcome

Change in Clinical Global Impression-Severity (CGI-S) Score
Change in SCI-PANSS Positive Symptom Score
Change in 16-Item Negative Symptom Assessment (NSA-16) Total Score
Change in SCI-PANSS Negative Symptom Score
Change in SCI-PANSS Negative Factor Score
Change in SCI-PANSS Total Score

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

- Diagnosed with schizophrenia at least 1 year before informed consent.
- Experienced a persistent psychotic episode within 2 months prior to screening requiring treatment modifications as judged by the investigator or sub-investigator.

• Exclude criteria: - 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.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT05368558