臨床研究等提出・公開システム

A 6-Week, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Cariprazine in the Acute Exacerbation of Schizophrenia, With an Additional 18-Week Blinded Extension Period

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

Otani Tetsuya

AbbVie G.K.

3-1-21, Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Patients and HCP Contact for

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Not Recruiting

June. 30, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.

- 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.

Both

Schizophrenia

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.

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

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

April. 06, 2022

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Taiwan