Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
- Registration Number
- NCT05368558
- Lead Sponsor
- AbbVie
- 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 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 6 weeks. Upon completion of 6-week treatment period, participants will be eligible to receive oral capsules of cariprazine for additional 18 weeks. The safety follow up period will follow after for an additional 8 weeks.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 34
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Cariprazine 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 Cariprazine 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 Measures
Name Time Method Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Total Score Baseline (Week 0) through Week 6 SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Number of Participants Experiencing Adverse Events Up to approximately 32 Weeks An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
- Secondary Outcome Measures
Name Time Method Change in SCI-PANSS Total Score Baseline (Week 0) through Week 24 SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Change in SCI-PANSS Positive Symptom Score Baseline (Week 0) through Week 24 SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Change in 16-Item Negative Symptom Assessment (NSA-16) Total Score Baseline (Week 0) through Week 24 NSA-16 is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from "not reduced" (1) to "severely reduced or absent" (6).
Change in SCI-PANSS Negative Factor Score Baseline (Week 0) through Week 24 SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Change in Clinical Global Impression-Severity (CGI-S) Score Baseline (Week 0) through Week 24 CGI-S is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from "normal, to at all ill" (1) to "among the most extremely ill patients" (5), with higher scores indicating greater anxiety severity.
Change in SCI-PANSS Negative Symptom Score Baseline (Week 0) through Week 24 SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Trial Locations
- Locations (52)
Hayakawa Clinic /ID# 242432
🇯🇵Kure City, Hiroshima, Japan
National Hospital Organization Kure Medical Center /ID# 243405
🇯🇵Kure-shi, Hiroshima, Japan
Hokkaido University Hospital /ID# 243245
🇯🇵Sapporo-shi, Hokkaido, Japan
Narimasu Kosei Hospital /ID# 243107
🇯🇵Banqiao Qu, Tokyo, Japan
Nishigahara Hospital /ID# 243312
🇯🇵Kita-ku, Tokyo, Japan
Taipei City Hospital, Songde Branch /ID# 241600
🇨🇳Taipei City, Taiwan
Fukuoka University Hospital /ID# 244404
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kuramitsu Hospital /ID# 242511
🇯🇵Fukuoka-shi, Fukuoka, Japan
Shiranui Hospital /ID# 243717
🇯🇵Omuta-shi, Fukuoka, Japan
Goryokai Hospital /ID# 242420
🇯🇵Sapporo-shi, Hokkaido, Japan
Gifu University Hospital /ID# 246238
🇯🇵Gifu-shi, Gifu, Japan
Taniyama Hospital /ID# 242385
🇯🇵Kagoshima-shi, Kagoshima, Japan
Yokohama City University Hospital /ID# 244944
🇯🇵Yokohama-shi, Kanagawa, Japan
Maizuru Medical Center /ID# 243450
🇯🇵Maizuru, Kyoto, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 242443
🇯🇵Kyoto-shi, Kyoto, Japan
Asakayama General Hospital /ID# 242732
🇯🇵Sakai, Osaka, Japan
Rainbow & Sea Hospital /ID# 242699
🇯🇵Karatsu-shi, Saga, Japan
Tokushima University Hospital /ID# 250056
🇯🇵Tokushima-shi, Tokushima, Japan
Ongata Hospital /ID# 256975
🇯🇵Hachioji-shi, Tokyo, Japan
National Center of Neurology and Psychiatry /ID# 242677
🇯🇵Kodaira-shi, Tokyo, Japan
Minamitoyama Nakagawa Hospital /ID# 243616
🇯🇵Toyama, Japan
Bali Psychiatric Center /ID# 241597
🇨🇳New Taipei City, New Taipei, Taiwan
Changhua Christian Hospital /ID# 241524
🇨🇳Changhua City, Changhua County, Taiwan
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533
🇨🇳Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528
🇨🇳Kaohsiung, Taiwan
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653
🇨🇳New Taipei City, Taiwan
Taichung Veterans General Hospital /ID# 246200
🇨🇳Taichung, Taiwan
Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540
🇨🇳Tainan, Taiwan
Taoyuan Psychiatric Center, MOHW /ID# 241691
🇨🇳Taoyuan, Taiwan
Akita University Hospital /ID# 245941
🇯🇵Akita-shi, Akita, Japan
Nara Medical University Hospital /ID# 242561
🇯🇵Kashihara-shi, Nara, Japan
Hizen Psychiatric Center /ID# 243239
🇯🇵Kanzaki-gun, Saga, Japan
Yuge Hospital /ID# 242849
🇯🇵Kumamoto-shi, Kumamoto, Japan
Linkou Chang Gung Memorial Hospital /ID# 241520
🇨🇳Taoyuan City, Taiwan
IUHW Narita Hospital /ID# 243870
🇯🇵Narita-shi, Chiba, Japan
Holy Cross Hospital /ID# 242673
🇯🇵Toki-shi, Gifu, Japan
Mie University Hospital /ID# 244710
🇯🇵Tsu-shi, Mie, Japan
Tochigi Prefectural Okamotodai Hospital /ID# 248855
🇯🇵Utsunomiya-shi, Tochigi, Japan
Shin-abuyama Hospital /ID# 243138
🇯🇵Takatsuki, Japan
National Taiwan University Hospital - Yunlin Branch /ID# 241537
🇨🇳Douliu City, Taiwan
Tokyo Metropolitan Matsuzawa Hospital /ID# 245272
🇯🇵Setagaya-ku, Tokyo, Japan
Mental Support Soyokaze Hospital /ID# 242512
🇯🇵Ueda-shi, Nagano, Japan
Juntendo Univ Koshigaya Hospital /ID# 248502
🇯🇵Koshigaya-shi, Saitama, Japan
Chung Shan Medical University Hospital /ID# 241543
🇨🇳Taichung, Taiwan
Tri-Service General Hospital Beitou Branch /ID# 241563
🇨🇳Taipei, Taiwan
Sapporo Medical University Hospital /ID# 245135
🇯🇵Sapporo-shi, Hokkaido, Japan
Kagawa University Hospital /ID# 243772
🇯🇵Kita-gun, Kagawa, Japan
Inuo Hospital /ID# 243310
🇯🇵Tosu-shi, Saga, Japan
Numazu Chuo Hospital /ID# 245275
🇯🇵Numazu-shi, Shizuoka, Japan
Wakayama Medical University Hospital /ID# 251105
🇯🇵Wakayama-shi, Wakayama, Japan
TsaoTun Psychiatric Center, MOHW /ID# 246012
🇨🇳Nantou, Taiwan
Taipei Veterans General Hospital /ID# 241522
🇨🇳Taipei City, Taipei, Taiwan