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

Sponsor
AbbVie
Study ID
NCT05368558
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    Oral Capsule
  • Placebo — DRUG
    Oral Capsule

Study Details

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 safe and effective cariprazine is in treating adult participants with schizophrenia in Japan and Taiwan. Adverse events and change in disease activity will be assessed. Cariprazine (VRAYLAR) is an approved drug for the treatment of schizophrenia in the United States. In the first 6-week period, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In the next 18-week period, participants will have the option to receive 1 of 3 doses of cariprazine. Approximately 250 adult participants, 18-65 years of age with schizophrenia will be enrolled in approximately 55 sites across Taiwan and Japan. Participants will receive oral capsules of Cariprazine or placebo for the 6-week Double-blind Period (DBP). Upon completion of 6-week DBP, participants will be eligible to receive oral capsules of Cariprazine for additional 18 weeks in the Blinded Extension Period (BEP), followed by an 8-week safety follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

Start date
Aug 18, 2022
Status verified
Oct 2025
Primary completion
Sep 20, 2024
Completion
Sep 20, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cariprazine
    Participants will receive cariprazine Dose A daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
  • Placebo Comparator: Placebo
    Participants will receive placebo daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks) ]

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