A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Ps… (NCT04092686) | Clinical Trial Compass
CompletedPhase 3
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
United States, Bulgaria, Croatia464 participantsStarted 2019-10-14
Plain-language summary
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female participant between 18 to 65 years of age (inclusive) at the time of consent.
. Participant must give written informed consent and privacy authorization prior to participation in the study.
. Participant meets the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5 )criteria for schizophrenia as established by clinical interview at screeing.
. Participant must have a Clinical Global Impression - Severity (CGI-S) score ≥ 4.
. Participant must have a Positive and Negative Syndrome Scale (PANSS) total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content.
. Participant has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial measured symptom changes using something called the PANSS Total Score over just 6 weeks — can you help me understand whether 6 weeks is enough time to know if a treatment is truly working for schizophrenia, and what that means for interpreting the results?
2Since this is a completed Phase 3 trial, has the data been published yet, and what did the results show about how well and how safely the investigational drug worked compared to existing options?
3The trial focused specifically on people who were acutely psychotic — does my current situation match what the trial was studying, and would that affect whether its findings are relevant to my case?
4Given that this trial is now completed, is the investigational drug being reviewed for approval, and could I potentially access it through another pathway, or would my doctor recommend sticking with currently approved treatments first?
5Phase 3 trials are generally designed to confirm effectiveness and monitor side effects in a larger group — what serious or common side effects showed up in this trial that I should weigh against the potential benefits?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in PANSS Total Score at Week 6
Timeframe: Baseline, Week 6
Trial details
NCT IDNCT04092686
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
. Participant has marked deterioration of functioning in one or more areas.
. Participant is, in the opinion of the Investigator, generally healthy based on screening medical history, physical examination (PE), neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values.
Exclusion criteria
. Participant has 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 or Sponsor, 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 are not the primary focus of treatment.
. Participant is at significant risk of harming self, others, or objects based on Investigator's judgment.
. Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study
. Female participant who is pregnant or lactating
. Participant has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.