SchizophreniaPhase 1NCT01972711
Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics
A Phase 1 study testing SEP-363856 and Amisulpride in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites in United Kingdom.
Trial summary
This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male and female volunteers with high or low schizotype characteristics. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SEP-363856 and Amisulpride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2014to Jul 2015
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 45 years, inclusive, at Day 1.
- Subject must be healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring within four weeks of randomisation. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Subject must be normotensive with sitting (5 minutes) blood pressure between the range of 90 to 150 mm Hg systolic, inclusive, and 60 to 90 mm Hg diastolic, inclusive, at Screening.
- Subject must have sitting (5 minutes) heart rate ≥ 50 beats per minute at Screening.
- Subject must agree to use one of the following birth control/contraception methods from Screening until 90 days after receiving study drug.
- Female subject of child bearing potential (≤ 65 years) should be surgically sterile or abstinent or, if sexually active, must use an adequate method of contraception in addition to their partner(s) using a barrier method.
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- Male subject with female partner(s) of childbearing potential must take appropriate precautions to avoid fathering a child and use barrier contraception, in addition to their female partner(s) using another method.
- Male subject must not donate sperm.
- Acceptable forms of contraception are as follows:
- Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel, film, cream or pessary.
- Non-hormone containing intrauterine methods: intrauterine devices or systems.
- Other: prescription oral contraceptives, contraceptive injections, contraceptive implant, contraceptive vaginal ring, hormonal intrauterine device, double-barrier method, contraceptive patch, or male partner sterilisation.
- Subject must have normal ECG results, including QTcF < 450msec (for men) or < 470 ms (for women) (based on the Fridericia correction where QTcF = QT/RR0.33) at Screening.
- Subject must be a completely fluent English speaker who, in the opinion of the Investigator, is capable of completing the fMRI and behavioural tasks.
- Subject must be right-handed.
- Subject must have acceptable weight as defined by BMI (weight [kg]/height [m]²) range of 18 to 35 kg/m², inclusive at Screening.
- Subject must be a non-smoker or light smoker (≤ 10 cigarettes per day).
- Subject must have signed the informed consent form prior to the first study-related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Subject in the low schizotypy group must have an SPQ score < 10 at Screening.
- Subject in the high schizotypy group must have an SPQ score >43 at Screening
Who cannot join
- Subject with a history of alcohol or substance dependence within the last 12 months from Screening.
- Subject with a positive urine drug screen at Screening or Day 1. One re-test within 1 to 3 days is permitted if positive result is believed to be due to licenced opiate-based medication or ingestion of poppy seeds. In this event, re-test result will be used for assessing entry criterion and must be completed prior to randomisation.
- Subject with a positive alcohol breath test at Screening or Day 1.
- Female subject with a positive pregnancy test at Screening or Day 1.
- Female subject currently pregnant or trying to get pregnant or currently breast feeding.
- Subject who consumes large amounts of caffeinated drinks (more than 8 cups of standard caffeinated drinks (tea, instant coffee) or 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day).
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- Subject with a relevant history, or presence upon clinical examination, of cardiac, ophthalmologic, pulmonary, endocrine (diabetes), blood disease, gastro-intestinal, hepatic or renal disease or other condition which in the opinion of the Investigator could interfere with the test procedures.
- Subject with a history of cancer, except for basal cell or Stage 1 squamous cell carcinoma of the skin which has been in remission for at least 5 years prior to Day 1.
- Subject meets the diagnostic criteria for schizophrenia, or any other psychotic disorder, as determined by the SCID-I at Screening
- Subject with a history of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, depression, seizures, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation).
- Subject with a history of positive HIV test.
- Subject with a history of, or current condition of, migraine headaches or has undergone operations to the head.
- Subject with a significant hearing impairment which, in the opinion of the Investigator, may interfere with the performance of the behavioural tasks or fMRI tasks.
- Subject with a significant visual impairment including colour blindness, or history of ocular treatment including corrective laser eye surgery, or ongoing condition, which in the opinion of the Investigator may interfere with the performance of the behavioural tasks or fMRI tasks.
- Subject received prescribed medication within 28 days prior to Day 1 (apart from the contraceptive pill). Subjects who have taken prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety (see Section 10.2, Concomitant Medications).
- Subject received non-prescription medication, including supplements such as vitamins and herbal supplements within 48 hours prior to Day 1 (apart from paracetamol). Subjects who have taken non-prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety (see Section 10.2, Concomitant Medications).
- Subject received an experimental drug and / or used an experimental medical device within 30 days of randomisation or within a period less than 5 times the drug's half-life, whichever is longer.
- Subject with a known hypersensitivity to SEP-363856 or amisulpride or any of their excipients.
- Subject with a history of severe drug allergy or hypersensitivity.
- Subject who is unable or unwilling to comply with study procedures, including study prohibitions and restrictions (see Section 10.2, Concomitant Medications and Section 10.3, Restrictions).
- Subject with previous experience with the ETB.
- Subject with a diagnosis of dyslexia.
- Subject with a history of claustrophobia or inability to tolerate scanner environment.
- Subject who fulfills any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants).
- Subject with a clinically relevant structural brain abnormality as determined by prior MRI scan.
- Subject with planned medical treatment within the study period that might interfere with the study procedures.
- Subject who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator.
- Subject is a staff member or the relative of a staff member, or is in a subordinate relationship with the Investigator.
- Subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the C-SSRS.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Psychiatry, University of Oxford, Warneford Hospital
Headington, Oxford, OX3 7JX
University of Manchester, Neuroscience and Psychiatry Unit
Manchester, M13 9PT
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Study of the Effects of SEP 363856 and Amisulpride on BOLD-fMRI Signal in Healthy Male and Female Volunteers With High or Low Schizotype Characteristics.
This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male and female volunteers with high or low schizotype characteristics.
Read the detailed description
The study is a randomized, double-blind, placebo-controlled functional magnetic resonance imaging (fMRI) study of the effects of a single dose of SEP-363856 and amisulpride on blood oxygen level dependent (BOLD) signal in healthy male and female volunteers with high or low schizotype characteristics.
- Conditions
- Schizophrenia
- Being tested
- SEP-363856, Amisulpride, Placebo
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEP-363856Drug
SEP-36385625 as a single oral dose of 50 mg
AmisulprideDrug
Amisulpride as a single oral dose of 400 mg
PlaceboDrug
single oral dose placebo
| Study group | Role | What they receive |
|---|---|---|
| SEP-363856 | Experimental | Single-dose SEP-363856 50 mg Receives: Drug: SEP-363856 |
| Amisulpride | Active comparator | Single-dose Amisulpride 400 mg. Receives: Drug: Amisulpride |
| Placebo | Placebo comparator | Matched placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD fMRI activity in key regions of interest (ROIs) while performing the Monetary Incentive Delay (MID), N-back, and Signal detection (SD) tasks after a single-dose of study medication
Measured: Up to 6 Weeks
Secondary outcomes (3)
Behavioural performance in the MID task, includes measurements of trial accuracy, trial duration, trial reaction time and amount of money won.
Measured: Up to 6 Weeks
Behavioural performance in the N-back task, includes measurements of accuracy (% correct for each trial type), reaction time and target sensitivity (d').
Measured: Up to 6 Weeks
Behavioural performance in the SD task, includes measurements of correct and incorrect responses.
Measured: Up to 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972711
- Sponsor's protocol ID
- SEP361-104
- Status last verified
- Jun 2024
- First submitted
- 24 Oct 2013
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Publications
Perini F, Nazimek JM, Mckie S, Capitao LP, Scaife J, Pal D, Browning M, Dawson GR, Nishikawa H, Campbell U, Hopkins SC, Loebel A, Elliott R, Harmer CJ, Deakin B, Koblan KS. Effects of ulotaront on brain circuits of reward, working memory, and emotion processing in healthy volunteers with high or low schizotypy. Schizophrenia (Heidelb). 2023 Aug 7;9(1):49. doi: 10.1038/s41537-023-00385-6.
PubMed 37550314
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-dose, Study of the Effects of SEP 363856 and Amisulpride on BOLD-fMRI Signal in Healthy Male and Female Volunteers With High or Low Schizotype Characteristics.
- ClinicalTrials.gov ID
- NCT01972711
- Acronym / sponsor ID
- SEP361-104
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Oct 2013 (estimated)
- 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.
This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male and female volunteers with high or low schizotype characteristics.
Detailed description
The study is a randomized, double-blind, placebo-controlled functional magnetic resonance imaging (fMRI) study of the effects of a single dose of SEP-363856 and amisulpride on blood oxygen level dependent (BOLD) signal in healthy male and female volunteers with high or low schizotype characteristics.
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 | Experimental | Drug: SEP-363856Single-dose SEP-363856 50 mg |
| Amisulpride | Active comparator | Drug: AmisulprideSingle-dose Amisulpride 400 mg. |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Male or female aged 18 to 45 years, inclusive, at Day 1.
- Subject must be healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring within four weeks of randomisation. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Subject must be normotensive with sitting (5 minutes) blood pressure between the range of 90 to 150 mm Hg systolic, inclusive, and 60 to 90 mm Hg diastolic, inclusive, at Screening.
- Subject must have sitting (5 minutes) heart rate ≥ 50 beats per minute at Screening.
- Subject must agree to use one of the following birth control/contraception methods from Screening until 90 days after receiving study drug.
Key exclusion criteria (29 listed)
- Subject with a history of alcohol or substance dependence within the last 12 months from Screening.
- Subject with a positive urine drug screen at Screening or Day 1. One re-test within 1 to 3 days is permitted if positive result is believed to be due to licenced opiate-based medication or ingestion of poppy seeds. In this event, re-test result will be used for assessing entry criterion and must be completed prior to randomisation.
- Subject with a positive alcohol breath test at Screening or Day 1.
- Female subject with a positive pregnancy test at Screening or Day 1.
- Female subject currently pregnant or trying to get pregnant or currently breast feeding.
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-363856SEP-36385625 as a single oral dose of 50 mg | Drug | SEP-363856 |
| AmisulprideAmisulpride as a single oral dose of 400 mg | Drug | Amisulpride |
| Placebosingle oral dose placebo | Drug | Placebo |
Primary outcome
BOLD fMRI activity in key regions of interest (ROIs) while performing the Monetary Incentive Delay (MID), N-back, and Signal detection (SD) tasks after a single-dose of study medication
Time frame: Up to 6 Weeks
3 secondary outcomes
Behavioural performance in the MID task, includes measurements of trial accuracy, trial duration, trial reaction time and amount of money won.
Time frame: Up to 6 Weeks
Behavioural performance in the N-back task, includes measurements of accuracy (% correct for each trial type), reaction time and target sensitivity (d').
Time frame: Up to 6 Weeks
Behavioural performance in the SD task, includes measurements of correct and incorrect responses.
Time frame: Up to 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 37550314Perini F, Nazimek JM, Mckie S, Capitao LP, Scaife J, Pal D, Browning M, Dawson GR, Nishikawa H, Campbell U, Hopkins SC, Loebel A, Elliott R, Harmer CJ, Deakin B, Koblan KS. Effects of ulotaront on brain circuits of reward, working memory, and emotion processing in healthy volunteers with high or low schizotypy. Schizophrenia (Heidelb). 2023 Aug 7;9(1):49. doi: 10.1038/s41537-023-00385-6.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SEP-363856 and Amisulpride in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites in United Kingdom.
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 20 inclusion and 29 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: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BOLD fMRI activity in key regions of interest (ROIs) while performing the Monetary Incentive Delay (MID), N-back, and Signal detection (SD) tasks after a single-dose of study medication (time frame: Up to 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01972711, which also lists 1 linked publication.
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 26 Jun 2024.