SchizophreniaPhase 3509 JPN SchzNCT05368558
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
A Phase 3 study testing Cariprazine in people with Schizophrenia, run by AbbVie at 52 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cariprazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 52 sitesin 2 countries
- Study dates
- 18 Aug 2022to 20 Sep 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
52 sites in 2 countries.
52 sites in 2 countries
Japan37 sites
Akita University Hospital /ID# 245941
Akita, Akita, 010-8543
Narimasu Kosei Hospital /ID# 243107
Banqiao Qu, Tokyo, 175-0091
Fukuoka University Hospital /ID# 244404
Fukuoka, Fukuoka, 814-0180
Kuramitsu Hospital /ID# 242511
Fukuoka, Fukuoka, 819-0037
Gifu University Hospital /ID# 246238
Gifu, Gifu, 501-1194
Ongata Hospital /ID# 256975
Hachioji-shi, Tokyo, 192-0153
Taniyama Hospital /ID# 242385
Kagoshima, Kagoshima-ken, 891-0111
Hizen Psychiatric Center /ID# 243239
Kanzaki-gun, Saga-ken, 842-0192
Rainbow & Sea Hospital /ID# 242699
Karatsu-shi, Saga-ken, 847-0031
Nara Medical University Hospital /ID# 242561
Kashihara-shi, Nara, 634-8522
Kagawa University Hospital /ID# 243772
Kita-gun, Kagawa-ken, 761-0793
Nishigahara Hospital /ID# 243312
Kita-ku, Tokyo, 114-0024
National Center of Neurology and Psychiatry /ID# 242677
Kodaira-shi, Tokyo, 187-8551
Juntendo Univ Koshigaya Hospital /ID# 248502
Koshigaya-shi, Saitama, 343-0032
Yuge Hospital /ID# 242849
Kumamoto, Kumamoto, 861-8002
Hayakawa Clinic /ID# 242432
Kure, Hiroshima, 737-0111
National Hospital Organization Kure Medical Center /ID# 243405
Kure-shi, Hiroshima, 737-0023
Duplicate_University Hospital Kyoto Prefectural University of Medicine /ID# 242443
Kyoto, Kyoto, 602-8566
Maizuru Medical Center /ID# 243450
Maizuru, Kyoto, 625-8502
International University of Health and Welfare Narita Hospital /ID# 243870
Narita-shi, Chiba, 2868520
Numazu Chuo Hospital /ID# 245275
Numazu-shi, Shizuoka, 4108575
Shiranui Hospital /ID# 243717
Omuta-shi, Fukuoka, 836-0004
Asakayama General Hospital /ID# 242732
Sakai, Osaka, 590-0018
Goryokai Hospital /ID# 242420
Sapporo, Hokkaido, 002-8029
Sapporo Medical University Hospital /ID# 245135
Sapporo, Hokkaido, 060-8543
Duplicate_Hokkaido University Hospital /ID# 243245
Sapporo, Hokkaido, 060-8648
Tokyo Metropolitan Matsuzawa Hospital /ID# 245272
Setagaya-ku, Tokyo, 156-0057
Shin-abuyama Hospital /ID# 243138
Takatsuki, 569-1041
Holy Cross Hospital /ID# 242673
Toki-shi, Gifu, 509-5142
Tokushima University Hospital /ID# 250056
Tokushima, Tokushima, 770-8503
Inuo Hospital /ID# 243310
Tosu-shi, Saga-ken, 841-0081
Minamitoyama Nakagawa Hospital /ID# 243616
Toyama, 939-8073
Mie University Hospital /ID# 244710
Tsu, Mie-ken, 514-8507
Mental Support Soyokaze Hospital /ID# 242512
Ueda-shi, Nagano, 386-0401
Tochigi Prefectural Okamotodai Hospital /ID# 248855
Utsunomiya, Tochigi, 329-1104
Wakayama Medical University Hospital /ID# 251105
Wakayama, Wakayama, 641-8510
Yokohama City University Hospital /ID# 244944
Yokohama, Kanagawa, 236-0004
Taiwan15 sites
Changhua Christian Hospital /ID# 241524
Changhua City, Changhua County, 50006
National Taiwan University Hospital - Yunlin Branch /ID# 241537
Douliu, 640
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533
Kaohsiung City, Kaohsiung, 802
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528
Kaohsiung City, 807
TsaoTun Psychiatric Center, MOHW /ID# 246012
Nantou City, 54249
Bali Psychiatric Center /ID# 241597
New Taipei City, New Taipei, 249
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653
New Taipei City, 236
Chung Shan Medical University Hospital /ID# 241543
Taichung, 40201
Taichung Veterans General Hospital /ID# 246200
Taichung, 40705
Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540
Tainan, 71742
Taipei City Hospital, Songde Branch /ID# 241600
Taipei, 110
Tri-Service General Hospital Beitou Branch /ID# 241563
Taipei, 112
Taipei Veterans General Hospital /ID# 241522
Taipei City, Taipei, 11217
Taoyuan Psychiatric Center, MOHW /ID# 241691
Taoyuan, 33058
Linkou Chang Gung Memorial Hospital /ID# 241520
Taoyuan City, 333
About this study
Official title: 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
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.
Read more
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.
Read the 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 randomized to the arm that was eliminated, remained in that arm through DBP and their data are displayed by that arm for the DBP portion of the study in participant flow, baseline characteristics and safety sections. Data for all endpoints are presented as planned per final SAP.
- Conditions
- Schizophrenia
- Being tested
- Cariprazine, Placebo
- Keywords
- Schizophrenia, Cariprazine, VRAYLAR
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CariprazineDrug
Also called VRAYLAR
Oral Capsule
PlaceboDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine | Experimental | 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. Receives: Drug: Cariprazine |
| Placebo | Placebo comparator | 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. Receives: Drug: Cariprazine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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 drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Measured: From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks)
Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) to Week 6
Secondary outcomes (11)
Change in CGI-S Score From Baseline (Wk 0) to Week 6
Clinical Global Impression-Severity (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 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) to Week 6
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) to Week 6
Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6
Negative Symptom Assessment-16 (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 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) to Week 6
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) to Week 6
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) to Week 6
Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) and Week 6 to Week 24
Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24
Clinical Global Impression-Severity (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 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) and Week 6 to Week 24
Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24
Negative Symptom Assessment-16 (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 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Measured: Baseline (Wk 0) and Week 6 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start18 Aug 2022
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368558
- Sponsor's protocol ID
- M22-509
- Acronym
- 509 JPN Schz
- Status last verified
- Oct 2025
- First submitted
- 6 May 2022
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05368558
- Acronym / sponsor ID
- 509 JPN Schz / M22-509
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cariprazine, VRAYLAR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 randomized to the arm that was eliminated, remained in that arm through DBP and their data are displayed by that arm for the DBP portion of the study in participant flow, baseline characteristics and safety sections. Data for all endpoints are presented as planned per final SAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cariprazine | Experimental | Drug: CariprazineParticipants 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 | Placebo comparator | Drug: Cariprazine, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CariprazineAlso: VRAYLAROral Capsule | Drug | Cariprazine, Placebo |
| PlaceboOral Capsule | Drug | Placebo |
Primary outcome
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)
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 drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6.
Time frame: Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
11 secondary outcomes
Change in CGI-S Score From Baseline (Wk 0) to Week 6
Time frame: Baseline (Wk 0) to Week 6
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6
Time frame: Baseline (Wk 0) to Week 6
Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6
Time frame: Baseline (Wk 0) to Week 6
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6
Time frame: Baseline (Wk 0) to Week 6
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6
Time frame: Baseline (Wk 0) to Week 6
Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24
Time frame: Baseline (Wk 0) and Week 6 to Week 24
Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24
Time frame: Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Time frame: Baseline (Wk 0) and Week 6 to Week 24
Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24
Time frame: Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Time frame: Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24
Time frame: Baseline (Wk 0) and Week 6 to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
52 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cariprazine in people with Schizophrenia, run by AbbVie at 52 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Japan, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.