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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04825860
• Other study ID #: DA801201
• Secondary ID: jRCT2071210003
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: March 29, 2021
• Est. completion date: October 19, 2023

Study information

• Verified date: March 2024
• Source: Sumitomo Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: October 19, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SEP-363856 50 mg
Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
• SEP-363856 75 mg
Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
• Placebo
Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Co., Ltd.

Countries where clinical trial is conducted

China,  Japan,  Philippines,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Week 6	PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.	Week 6
Secondary	Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Week 6	The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.	Week 6