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

NCT ID: NCT04825860

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2023-10-19

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SEP-363856 50 mg/day

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.

Group Type: EXPERIMENTAL

SEP-363856 50 mg

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

SEP-363856 75 mg

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, China

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

The Affiliated Brain Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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

Changsha, Hu'nan, China

Shandong Daizhuang Hospital

Jining, Shandong, China

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

The Mental Health Center of Xi'an

Xian, Shanxi, China

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

Hotei Hospital

Kōnan, Aichi-ken, Japan

Okehazama Hospital Fujita Kokoro Care Center

Toyoake, Aichi-ken, Japan

Medical corporation Seijinkai Seinan Hospital

Hachinohe, Aomori, Japan

Kohnodai Hp., National Center for Global Health and Medicine

Ichikawa, Chiba, Japan

Shiranui Hospital

Omuta, Fukuoka, Japan

Juzenkai Oorin Hospital

Ōnojō, Fukuoka, Japan

Takeda General Hospital

Aizu-Wakamatsu, Fukushima, Japan

Mihara Hospital

Mihara, Hiroshima, Japan

Fujimidai Hospital

Hiratsuka, Kanagawa, Japan

Okinawa Tokushukai Hino Hospital

Yokohama, Kanagawa, Japan

Yatsushiro Kosei Hospital

Yatsushiro, Kumamoto, Japan

Miyakonojo Shinsei Hospital

Miyakonojō, Miyazaki, Japan

Shonan Hospital

Matsumoto, Nagano, Japan

Mental Support Soyokaze Hospital

Ueda, Nagano, Japan

NHO Ryukyu Hospital

Kunigami, Okinawa, Japan

Social welfare corporation Tenshinkai Kosaka hospital

Higashiosaka, Osaka, Japan

Kansai Medical University Medical Center

Moriguchi, Osaka, Japan

Nishiurakai Keihan Hospital

Moriguchi, Osaka, Japan

Neyagawa Sanatorium

Neyagawa, Osaka, Japan

Asakayama Hospital

Sakai, Osaka, Japan

Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital

Takatsuki, Osaka, Japan

NHO Hizen Psychiatric Center

Kanzaki, Saga-ken, Japan

Rainbow & Sea Hospital

Karatsu, Saga-ken, Japan

Nishi Kumagaya Hospital

Kumagaya, Saitama, Japan

Shiga university of medical science hospital

Ōtsu, Shiga, Japan

Negishi Hospital

Fuchū, Tokyo, Japan

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Narimasu Kosei Hospital

tabashi City, Tokyo, Japan

National Hospital Organization Hokuriku National Hospital

Nanto, Toyama, Japan

Azusakai Kawada Hospital

Takaoka, Toyama, Japan

Sanyokai Sanyo Hospital

Sakata, Yamagata, Japan

Akino Hospital

Tendō, Yamagata, Japan

Akita City Hospital

Akita, , Japan

Inokuchi Noma Hospital

Fukuoka, , Japan

Kuramitsu Hospital

Fukuoka, , Japan

Minkodo Aburayama Hospital

Fukuoka, , Japan

Satokai Yuge Hospital

Kumamoto, , Japan

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, , Japan

Mariveles Mental Wellness and General Hospital

Mariveles, Bataan, Philippines

St. Paul's Hospital of Iloilo, Inc.

Iloilo City, Iloilo, Philippines

Makati Medical Center

Makati City, National Capital Region, Philippines

National Center for Mental Health

Mandaluyong, National Capital Region, Philippines

Southern Philippines Medical Center

Davao City, , Philippines

Chang Gung Memorial Hospital, Keelung

Keelung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

China; Japan; Philippines; Taiwan

Other Identifiers

jRCT2071210003

Identifier Type: REGISTRY

Identifier Source: secondary_id

DA801201

Identifier Type: -

Identifier Source: org_study_id