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

NCT04825860 | Terminated Phase 2 DMC

• 2 other identifiers: DA801201jRCT2071210003
• Study Type: interventional
• Target: 83
• Locations: 4 countries
• Sites: 54

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Week 6

  Week 6

Study Arms (3)

SEP-363856 50 mg/day

EXPERIMENTAL

Subjects randomized to the SEP-363856 50 mg/day group will receive the assigned dose of SEP-363856 50 mg/day throughout the double-blind phase.

Drug: SEP-363856 50 mg

SEP-363856 75 mg/day

EXPERIMENTAL

Subjects randomized to the SEP-363856 75 mg/day group will receive SEP-363856 50 mg/day on Day 1 through Day 3 and then the assigned dose of SEP-363856 75 mg/day thereafter.

Drug: SEP-363856 75 mg

Placebo

PLACEBO COMPARATOR

Subjects randomized to the placebo group will receive placebo throughout the double-blind phase.

Drug: Placebo

Interventions

SEP-363856 50 mg DRUG

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 50 mg/day

SEP-363856 75 mg DRUG

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/day

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female between 18 to 65 years of age (inclusive) at the time of consent.
• Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
• Must have a CGI S score ≥ 4 (moderately ill) at Screening and Baseline.
• 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.
• 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.
• 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).

You may not qualify if:

• At significant risk of harming self, others, or objects based on Investigator's judgment.
• 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.
• Female subjects who are pregnant or lactating.
• Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: lead

Study Sites (54)

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Location

The Affiliated Brain Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The Second People's Hospital of Hunan Province/ Brain Hospital of Hunan Province

Changsha, Hu'nan, China

Location

Shandong Daizhuang Hospital

Jining, Shandong, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Location

The Mental Health Center of Xi'an

Xian, Shanxi, China

Location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

Location

Hotei Hospital

Kōnan, Aichi-ken, Japan

Location

Okehazama Hospital Fujita Kokoro Care Center

Toyoake, Aichi-ken, Japan

Location

Medical corporation Seijinkai Seinan Hospital

Hachinohe, Aomori, Japan

Location

Kohnodai Hp., National Center for Global Health and Medicine

Ichikawa, Chiba, Japan

Location

Shiranui Hospital

Omuta, Fukuoka, Japan

Location

Juzenkai Oorin Hospital

Ōnojō, Fukuoka, Japan

Location

Takeda General Hospital

Aizu-Wakamatsu, Fukushima, Japan

Location

Mihara Hospital

Mihara, Hiroshima, Japan

Location

Fujimidai Hospital

Hiratsuka, Kanagawa, Japan

Location

Okinawa Tokushukai Hino Hospital

Yokohama, Kanagawa, Japan

Location

Yatsushiro Kosei Hospital

Yatsushiro, Kumamoto, Japan

Location

Miyakonojo Shinsei Hospital

Miyakonojō, Miyazaki, Japan

Location

Shonan Hospital

Matsumoto, Nagano, Japan

Location

Mental Support Soyokaze Hospital

Ueda, Nagano, Japan

Location

NHO Ryukyu Hospital

Kunigami, Okinawa, Japan

Location

Social welfare corporation Tenshinkai Kosaka hospital

Higashiosaka, Osaka, Japan

Location

Kansai Medical University Medical Center

Moriguchi, Osaka, Japan

Location

Nishiurakai Keihan Hospital

Moriguchi, Osaka, Japan

Location

Neyagawa Sanatorium

Neyagawa, Osaka, Japan

Location

Asakayama Hospital

Sakai, Osaka, Japan

Location

Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital

Takatsuki, Osaka, Japan

Location

NHO Hizen Psychiatric Center

Kanzaki, Saga-ken, Japan

Location

Rainbow & Sea Hospital

Karatsu, Saga-ken, Japan

Location

Nishi Kumagaya Hospital

Kumagaya, Saitama, Japan

Location

Shiga university of medical science hospital

Ōtsu, Shiga, Japan

Location

Negishi Hospital

Fuchū, Tokyo, Japan

Location

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Location

Narimasu Kosei Hospital

tabashi City, Tokyo, Japan

Location

National Hospital Organization Hokuriku National Hospital

Nanto, Toyama, Japan

Location

Azusakai Kawada Hospital

Takaoka, Toyama, Japan

Location

Sanyokai Sanyo Hospital

Sakata, Yamagata, Japan

Location

Akino Hospital

Tendō, Yamagata, Japan

Location

Akita City Hospital

Akita, Japan

Location

Inokuchi Noma Hospital

Fukuoka, Japan

Location

Kuramitsu Hospital

Fukuoka, Japan

Location

Minkodo Aburayama Hospital

Fukuoka, Japan

Location

Satokai Yuge Hospital

Kumamoto, Japan

Location

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Japan

Location

Mariveles Mental Wellness and General Hospital

Mariveles, Bataan, Philippines

Location

St. Paul's Hospital of Iloilo, Inc.

Iloilo City, Iloilo, Philippines

Location

Makati Medical Center

Makati City, National Capital Region, Philippines

Location

National Center for Mental Health

Mandaluyong, National Capital Region, Philippines

Location

Southern Philippines Medical Center

Davao City, Philippines

Location

Chang Gung Memorial Hospital, Keelung

Keelung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: March 29, 2021
• Primary Completion: October 12, 2023
• Study Completion: October 19, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PH (5); JP (38); TW (3); CN (8)