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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05368558
• Other study ID #: M22-509
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 18, 2022
• Est. completion date: October 2, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: October 2, 2024
• Est. primary completion date: October 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion 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 Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Cariprazine
Oral Capsule
• Placebo
Oral Capsule

Locations

Country	Name	City	State
Japan	Akita University Hospital /ID# 245941	Akita-shi	Akita
Japan	Narimasu Kosei Hospital /ID# 243107	Banqiao Qu	Tokyo
Japan	Fukuoka University Hospital /ID# 244404	Fukuoka-shi	Fukuoka
Japan	Kuramitsu Hospital /ID# 242511	Fukuoka-shi	Fukuoka
Japan	Gifu University Hospital /ID# 246238	Gifu-shi	Gifu
Japan	Ongata Hospital /ID# 256975	Hachioji-shi	Tokyo
Japan	Taniyama Hospital /ID# 242385	Kagoshima-shi	Kagoshima
Japan	Hizen Psychiatric Center /ID# 243239	Kanzaki-gun	Saga
Japan	Rainbow & Sea Hospital /ID# 242699	Karatsu-shi	Saga
Japan	Nara Medical University Hospital /ID# 242561	Kashihara-shi	Nara
Japan	Kagawa University Hospital /ID# 243772	Kita-gun	Kagawa
Japan	Nishigahara Hospital /ID# 243312	Kita-ku	Tokyo
Japan	National Center of Neurology and Psychiatry /ID# 242677	Kodaira-shi	Tokyo
Japan	Juntendo Univ Koshigaya Hospital /ID# 248502	Koshigaya-shi	Saitama
Japan	Yuge Hospital /ID# 242849	Kumamoto-shi	Kumamoto
Japan	Hayakawa Clinic /ID# 242432	Kure City	Hiroshima
Japan	National Hospital Organization Kure Medical Center /ID# 243405	Kure-shi	Hiroshima
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 242443	Kyoto-shi	Kyoto
Japan	Maizuru Medical Center /ID# 243450	Maizuru	Kyoto
Japan	IUHW Narita Hospital /ID# 243870	Narita-shi	Chiba
Japan	Numazu Chuo Hospital /ID# 245275	Numazu-shi	Shizuoka
Japan	Shiranui Hospital /ID# 243717	Omuta-shi	Fukuoka
Japan	Asakayama General Hospital /ID# 242732	Sakai	Osaka
Japan	Goryokai Hospital /ID# 242420	Sapporo-shi	Hokkaido
Japan	Hokkaido University Hospital /ID# 243245	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 245135	Sapporo-shi	Hokkaido
Japan	Tokyo Metropolitan Matsuzawa Hospital /ID# 245272	Setagaya-ku	Tokyo
Japan	Shin-abuyama Hospital /ID# 243138	Takatsuki
Japan	Holy Cross Hospital /ID# 242673	Toki-shi	Gifu
Japan	Tokushima University Hospital /ID# 250056	Tokushima-shi	Tokushima
Japan	Inuo Hospital /ID# 243310	Tosu-shi	Saga
Japan	Minamitoyama Nakagawa Hospital /ID# 243616	Toyama
Japan	Mie University Hospital /ID# 244710	Tsu-shi	Mie
Japan	Mental Support Soyokaze Hospital /ID# 242512	Ueda-shi	Nagano
Japan	Tochigi Prefectural Okamotodai Hospital /ID# 248855	Utsunomiya-shi	Tochigi
Japan	Wakayama Medical University Hospital /ID# 251105	Wakayama-shi	Wakayama
Japan	Yokohama City University Hospital /ID# 244944	Yokohama-shi	Kanagawa
Taiwan	Changhua Christian Hospital /ID# 241524	Changhua City, Changhua County
Taiwan	National Taiwan University Hospital - Yunlin Branch /ID# 241537	Douliu City
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528	Kaohsiung
Taiwan	Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533	Kaohsiung City
Taiwan	TsaoTun Psychiatric Center, MOHW /ID# 246012	Nantou
Taiwan	Bali Psychiatric Center /ID# 241597	New Taipei City	New Taipei
Taiwan	New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653	New Taipei City
Taiwan	Chung Shan Medical University Hospital /ID# 241543	Taichung
Taiwan	Taichung Veterans General Hospital /ID# 246200	Taichung
Taiwan	Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540	Tainan
Taiwan	Tri-Service General Hospital Beitou Branch /ID# 241563	Taipei
Taiwan	Taipei City Hospital, Songde Branch /ID# 241600	Taipei City
Taiwan	Taipei Veterans General Hospital /ID# 241522	Taipei City	Taipei
Taiwan	Taoyuan Psychiatric Center, MOHW /ID# 241691	Taoyuan
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 241520	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Japan,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Adverse Events	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.	Up to approximately 32 Weeks
Primary	Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Total Score	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).	Baseline (Week 0) through Week 6
Secondary	Change in Clinical Global Impression-Severity (CGI-S) Score	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.	Baseline (Week 0) through Week 24
Secondary	Change in SCI-PANSS Positive Symptom Score	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).	Baseline (Week 0) through Week 24
Secondary	Change in 16-Item Negative Symptom Assessment (NSA-16) Total Score	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).	Baseline (Week 0) through Week 24
Secondary	Change in SCI-PANSS Negative Symptom Score	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).	Baseline (Week 0) through Week 24
Secondary	Change in SCI-PANSS Negative Factor Score	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).	Baseline (Week 0) through Week 24
Secondary	Change in SCI-PANSS Total Score	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).	Baseline (Week 0) through Week 24

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