Clinical trial NCT05368558: Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Cariprazine
VRAYLAR
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 32 Weeks
measure: Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Total Score
timeFrame: Baseline (Week 0) through Week 6
Secondary outcomes:
measure: Change in Clinical Global Impression-Severity (CGI-S) Score
timeFrame: Baseline (Week 0) through Week 24
measure: Change in SCI-PANSS Positive Symptom Score
timeFrame: Baseline (Week 0) through Week 24
measure: Change in 16-Item Negative Symptom Assessment (NSA-16) Total Score
timeFrame: Baseline (Week 0) through Week 24
measure: Change in SCI-PANSS Negative Symptom Score
timeFrame: Baseline (Week 0) through Week 24
measure: Change in SCI-PANSS Negative Factor Score
timeFrame: Baseline (Week 0) through Week 24
measure: Change in SCI-PANSS Total Score
timeFrame: Baseline (Week 0) through Week 24
Other outcomes:
Locations:
city: Akita-shi
country: Japan
facility: Akita University Hospital /ID# 245941
state: Akita
city: Narita-shi
country: Japan
facility: IUHW Narita Hospital /ID# 243870
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 244404
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kuramitsu Hospital /ID# 242511
state: Fukuoka
city: Omuta-shi
country: Japan
facility: Shiranui Hospital /ID# 243717
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital /ID# 246238
state: Gifu
city: Toki-shi
country: Japan
facility: Holy Cross Hospital /ID# 242673
state: Gifu
city: Kure City
country: Japan
facility: Hayakawa Clinic /ID# 242432
state: Hiroshima
city: Kure-shi
country: Japan
facility: National Hospital Organization Kure Medical Center /ID# 243405
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Goryokai Hospital /ID# 242420
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital /ID# 245135
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 243245
state: Hokkaido
city: Kita-gun
country: Japan
facility: Kagawa University Hospital /ID# 243772
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Taniyama Hospital /ID# 242385
state: Kagoshima
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital /ID# 244944
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Yuge Hospital /ID# 242849
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 242443
state: Kyoto
city: Maizuru
country: Japan
facility: Maizuru Medical Center /ID# 243450
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 244710
state: Mie
city: Ueda-shi
country: Japan
facility: Mental Support Soyokaze Hospital /ID# 242512
state: Nagano
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital /ID# 242561
state: Nara
city: Sakai
country: Japan
facility: Asakayama General Hospital /ID# 242732
state: Osaka
city: Kanzaki-gun
country: Japan
facility: Hizen Psychiatric Center /ID# 243239
state: Saga
city: Karatsu-shi
country: Japan
facility: Rainbow & Sea Hospital /ID# 242699
state: Saga
city: Tosu-shi
country: Japan
facility: Inuo Hospital /ID# 243310
state: Saga
city: Koshigaya-shi
country: Japan
facility: Juntendo Univ Koshigaya Hospital /ID# 248502
state: Saitama
city: Numazu-shi
country: Japan
facility: Numazu Chuo Hospital /ID# 245275
state: Shizuoka
city: Utsunomiya-shi
country: Japan
facility: Tochigi Prefectural Okamotodai Hospital /ID# 248855
state: Tochigi
city: Tokushima-shi
country: Japan
facility: Tokushima University Hospital /ID# 250056
state: Tokushima
city: Banqiao Qu
country: Japan
facility: Narimasu Kosei Hospital /ID# 243107
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Ongata Hospital /ID# 256975
state: Tokyo
city: Kita-ku
country: Japan
facility: Nishigahara Hospital /ID# 243312
state: Tokyo
city: Kodaira-shi
country: Japan
facility: National Center of Neurology and Psychiatry /ID# 242677
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Tokyo Metropolitan Matsuzawa Hospital /ID# 245272
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital /ID# 251105
state: Wakayama
city: Takatsuki
country: Japan
facility: Shin-abuyama Hospital /ID# 243138
city: Toyama
country: Japan
facility: Minamitoyama Nakagawa Hospital /ID# 243616
city: New Taipei City
country: Taiwan
facility: Bali Psychiatric Center /ID# 241597
state: New Taipei
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital /ID# 241522
state: Taipei
city: Changhua City, Changhua County
country: Taiwan
facility: Changhua Christian Hospital /ID# 241524
city: Douliu City
country: Taiwan
facility: National Taiwan University Hospital - Yunlin Branch /ID# 241537
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528
city: Nantou
country: Taiwan
facility: TsaoTun Psychiatric Center, MOHW /ID# 246012
city: New Taipei City
country: Taiwan
facility: New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital /ID# 241543
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 246200
city: Tainan
country: Taiwan
facility: Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540
city: Taipei City
country: Taiwan
facility: Taipei City Hospital, Songde Branch /ID# 241600
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital Beitou Branch /ID# 241563
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 241520
city: Taoyuan
country: Taiwan
facility: Taoyuan Psychiatric Center, MOHW /ID# 241691
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: