Schizophrenia
Conditions
Interventions
Double-Blind Phase:
390 participants will be randomly assigned to one of three groups: EA8001 15 mg (n=130), EA8001 30 mg (n=130), or placebo (n=130). The study drug will be administered orally twice
Sponsors
Chihiro Saito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese patients aged 18 years or older and younger than 65 years at the time of informed consent. 2.Patients with a primary diagnosis of schizophrenia established and confirmed based on DSM-5 criteria through a comprehensive psychiatric evaluation using the Mini-International Neuropsychiatric Interview. 3.Patients with medical-record documentation, prior to initiation of investigational product administration, of no response or inadequate response to at least two antipsychotic agents (including at least one second-generation antipsychotic), despite treatment for at least 6 weeks at appropriate doses and durations per package insert (for long-acting injectable antipsychotics, at least two administration / dosing cycles). 4.Patients with a Positive and Negative Syndrome Scale (PANSS) total score of 70 to 90 and a Clinical Global Impression-Severity score of 3 to 5 at screening and baseline. 5.Patients with, for at least 8 weeks prior to screening, no acute exacerbation requiring psychiatric hospitalization, incarceration, acute crisis intervention, or other marked symptom worsening, and investigator judgement that no change or addition to treatment is necessary.
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with a comorbid psychiatric disorder other than schizophrenia according to DSM-5 criteria (excluding substance use disorders related to caffeine or nicotine). 2.Patients clinically judged by the investigator or sub-investigator to be experiencing a first episode of schizophrenia. 3.Patients who are breastfeeding or pregnant at screening or baseline. 4.Patients who are currently taking prohibited concomitant medications or undergoing prohibited concomitant therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in PANSS Total Score at Week 12 of Study Drug Administration | — |
Contacts
Public ContactSaito Chihiro
EA Pharma Co., Ltd
Outcome results
None listed