SchizophreniaPhase 2/3NCT04825860
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
A Phase 2/3 study testing SEP-363856 50 mg and SEP-363856 75 mg in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 54 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SEP-363856 50 mg and SEP-363856 75 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 54 sitesin 4 countries
- Study dates
- 29 Mar 2021to 19 Oct 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
Who cannot join
- 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
- 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.
Trial locations and contacts
54 sites in 4 countries.
54 sites in 4 countries
Japan38 sites
Takeda General Hospital
Aizu-Wakamatsu, Fukushima
Akita City Hospital
Akita
Negishi Hospital
Fuchū, Tokyo
Inokuchi Noma Hospital
Fukuoka
Kuramitsu Hospital
Fukuoka
Minkodo Aburayama Hospital
Fukuoka
Medical corporation Seijinkai Seinan Hospital
Hachinohe, Aomori
Social welfare corporation Tenshinkai Kosaka hospital
Higashiosaka, Osaka
Fujimidai Hospital
Hiratsuka, Kanagawa
Kohnodai Hp., National Center for Global Health and Medicine
Ichikawa, Chiba
NHO Hizen Psychiatric Center
Kanzaki, Saga-ken
Rainbow & Sea Hospital
Karatsu, Saga-ken
National Center of Neurology and Psychiatry
Kodaira, Tokyo
Hotei Hospital
Kōnan, Aichi-ken
Nishi Kumagaya Hospital
Kumagaya, Saitama
Satokai Yuge Hospital
Kumamoto
NHO Ryukyu Hospital
Kunigami, Okinawa
Shonan Hospital
Matsumoto, Nagano
Mihara Hospital
Mihara, Hiroshima
Miyakonojo Shinsei Hospital
Miyakonojō, Miyazaki
Miyazaki Prefectural Miyazaki Hospital
Miyazaki
Kansai Medical University Medical Center
Moriguchi, Osaka
Nishiurakai Keihan Hospital
Moriguchi, Osaka
National Hospital Organization Hokuriku National Hospital
Nanto, Toyama
Neyagawa Sanatorium
Neyagawa, Osaka
Shiranui Hospital
Omuta, Fukuoka
Juzenkai Oorin Hospital
Ōnojō, Fukuoka
Shiga university of medical science hospital
Ōtsu, Shiga
Asakayama Hospital
Sakai, Osaka
Sanyokai Sanyo Hospital
Sakata, Yamagata
Narimasu Kosei Hospital
tabashi City, Tokyo
Azusakai Kawada Hospital
Takaoka, Toyama
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
Takatsuki, Osaka
Akino Hospital
Tendō, Yamagata
Okehazama Hospital Fujita Kokoro Care Center
Toyoake, Aichi-ken
Mental Support Soyokaze Hospital
Ueda, Nagano
Yatsushiro Kosei Hospital
Yatsushiro, Kumamoto
Okinawa Tokushukai Hino Hospital
Yokohama, Kanagawa
China8 sites
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality
Peking University Sixth Hospital
Beijing, Beijing Municipality
The Second People's Hospital of Hunan Province/ Brain Hospital of Hunan Province
Changsha, Hu'nan
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Shandong Daizhuang Hospital
Jining, Shandong
Shanghai Mental Health Center
Shanghai, Shanghai Municipality
Tianjin Anding Hospital
Tianjin, Tianjin Municipality
The Mental Health Center of Xi'an
Xian, Shanxi
Philippines5 sites
Southern Philippines Medical Center
Davao City
St. Paul's Hospital of Iloilo, Inc.
Iloilo City, Iloilo
Makati Medical Center
Makati City, National Capital Region
National Center for Mental Health
Mandaluyong, National Capital Region
Mariveles Mental Wellness and General Hospital
Mariveles, Bataan
Taiwan3 sites
Chang Gung Memorial Hospital, Keelung
Keelung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
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
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.
Read the 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
- Being tested
- SEP-363856 50 mg, SEP-363856 75 mg, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEP-363856 50 mgDrug
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 mgDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: SEP-363856 75 mg |
| Placebo | Placebo comparator | Subjects randomized to the placebo group will receive placebo throughout the double-blind phase. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 6
Secondary outcomes (1)
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.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start29 Mar 2021
- Primary completion12 Oct 2023
- Study completion19 Oct 2023
Why it stopped: Due to company business strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825860
- Sponsor's protocol ID
- DA801201
- Other IDs
- jRCT2071210003
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04825860
- Acronym / sponsor ID
- DA801201
- Conditions
- Schizophrenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to company business strategy
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SEP-363856 50 mg/day | Experimental | Drug: SEP-363856 50 mgSubjects 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. |
| SEP-363856 75 mg/day | Experimental | Drug: SEP-363856 75 mgSubjects 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. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to the placebo group will receive placebo throughout the double-blind phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEP-363856 50 mgSubjects 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. | Drug | SEP-363856 50 mg/day |
| SEP-363856 75 mgSubjects 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. | Drug | SEP-363856 75 mg/day |
| PlaceboSubjects 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. | Drug | Placebo |
Primary outcome
Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Week 6
Time frame: 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.
1 secondary outcome
Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Week 6
Time frame: Week 6
Results and safety
The study was stopped early (reason given: Due to company business strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SEP-363856 50 mg and SEP-363856 75 mg in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 54 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Japan, China, Philippines, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to company business strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.