Clinical trial NCT04825860: A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase
Official title: A Randomized, Double-blind, Parallel-group, Placebo Controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in Acutely Psychotic Patients With Schizophrenia, Followed by an Open-label Extension Phase
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 83
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: A clinical study to investigate the effect of 2 doses of an investigational drug in acutely psychotic adult patients with schizophrenia. The study will consist of a double-blind phase followed by an open-label extension phase.

Detailed description: A Phase 2/3 Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Patients with Schizophrenia, Followed by an Open-label Extension Phase.

The double-blind phase is to evaluate the efficacy and safety of 2 doses of SEP-363856 (50 and 75 mg/day) versus placebo over 6 weeks in acutely psychotic patients with schizophrenia. This phase is projected to randomize approximately 480 subjects to 3 treatments (SEP-363856 50 mg/day, SEP-363856 75 mg/day, placebo) in a 1:1:1 ratio. The completers of the double-blind phase will be able to enroll into the 12-week open-label phase during which the long term safety and effectiveness of-SEP 363856 will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities. If the subject is considered a minor according to local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
2. Male or female between 18 to 65 years of age (inclusive) at the time of consent.
3. Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
4. Must have a CGI S score ≥ 4 (moderately ill) at Screening and Baseline.
5. Must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), and unusual thought content (G9) at Screening and Baseline.
6. Must have an acute exacerbation of psychotic symptoms (no longer than 2 months prior to providing informed consent for this study). The acute exacerbation should include:

   a. Marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene.
7. In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination (PE), vital signs, ECG, and clinical laboratory values (hematology, chemistry, and urinalysis).

Exclusion Criteria:

1. Have a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment
2. At significant risk of harming self, others, or objects based on Investigator's judgment.
3. Have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
4. Female subjects who are pregnant or lactating.
5. Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.

Primary outcomes:
measure: Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Week 6
timeFrame: Week 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Guangzhou
country: China
facility: The Affiliated Brain Hospital of Guangzhou Medical University
state: Guangdong
city: Changsha
country: China
facility: The Second People's Hospital of Hunan Province/ Brain Hospital of Hunan Province
state: Hunan
city: Jining
country: China
facility: Shandong Daizhuang Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Xian
country: China
facility: The Mental Health Center of Xi'an
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
city: Konan
country: Japan
facility: Hotei Hospital
state: Aichi
city: Toyoake
country: Japan
facility: Okehazama Hospital Fujita Kokoro Care Center
state: Aichi
city: Hachinohe
country: Japan
facility: Medical corporation Seijinkai Seinan Hospital
state: Aomori
city: Ichikawa
country: Japan
facility: Kohnodai Hp., National Center for Global Health and Medicine
state: Chiba
city: Omuta
country: Japan
facility: Shiranui Hospital
state: Fukuoka
city: Onojo
country: Japan
facility: Juzenkai Oorin Hospital
state: Fukuoka
city: Aizu-Wakamatsu
country: Japan
facility: Takeda General Hospital
state: Fukushima
city: Mihara
country: Japan
facility: Mihara Hospital
state: Hiroshima
city: Hiratsuka
country: Japan
facility: Fujimidai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Okinawa Tokushukai Hino Hospital
state: Kanagawa
city: Yatsushiro
country: Japan
facility: Yatsushiro Kosei Hospital
state: Kumamoto
city: Miyakonojo
country: Japan
facility: Miyakonojo Shinsei Hospital
state: Miyazaki
city: Matsumoto
country: Japan
facility: Shonan Hospital
state: Nagano
city: Ueda
country: Japan
facility: Mental Support Soyokaze Hospital
state: Nagano
city: Kunigami
country: Japan
facility: NHO Ryukyu Hospital
state: Okinawa
city: Higashiosaka
country: Japan
facility: Social welfare corporation Tenshinkai Kosaka hospital
state: Osaka
city: Moriguchi
country: Japan
facility: Kansai Medical University Medical Center
state: Osaka
city: Moriguchi
country: Japan
facility: Nishiurakai Keihan Hospital
state: Osaka
city: Neyagawa
country: Japan
facility: Neyagawa Sanatorium
state: Osaka
city: Sakai
country: Japan
facility: Asakayama Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
state: Osaka
city: Kanzaki
country: Japan
facility: NHO Hizen Psychiatric Center
state: Saga
city: Karatsu
country: Japan
facility: Rainbow & Sea Hospital
state: Saga
city: Kumagaya
country: Japan
facility: Nishi Kumagaya Hospital
state: Saitama
city: Otsu
country: Japan
facility: Shiga university of medical science hospital
state: Shiga
city: Fuchu
country: Japan
facility: Negishi Hospital
state: Tokyo
city: Itabashi
country: Japan
facility: Narimasu Kosei Hospital
state: Tokyo
city: Kodaira
country: Japan
facility: National Center of Neurology and Psychiatry
state: Tokyo
city: Nanto
country: Japan
facility: National Hospital Organization Hokuriku National Hospital
state: Toyama
city: Takaoka
country: Japan
facility: Azusakai Kawada Hospital
state: Toyama
city: Sakata
country: Japan
facility: Sanyokai Sanyo Hospital
state: Yamagata
city: Tendo
country: Japan
facility: Akino Hospital
state: Yamagata
city: Akita
country: Japan
facility: Akita City Hospital
city: Fukuoka
country: Japan
facility: Inokuchi Noma Hospital
city: Fukuoka
country: Japan
facility: Kuramitsu Hospital
city: Fukuoka
country: Japan
facility: Minkodo Aburayama Hospital
city: Kumamoto
country: Japan
facility: Satokai Yuge Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital
city: Mariveles
country: Philippines
facility: Mariveles Mental Wellness and General Hospital
state: Bataan
city: Iloilo City
country: Philippines
facility: St. Paul's Hospital of Iloilo, Inc.
state: Iloilo
city: Makati
country: Philippines
facility: Makati Medical Center
state: Metro Manila
city: Mandaluyong
country: Philippines
facility: National Center for Mental Health
state: Metro Manila
city: Davao
country: Philippines
facility: Southern Philippines Medical Center
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: