Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT06107803
Eligibility Criteria:
Inclusion Criteria:
* Provided informed consent
* Body mass index (BMI) \< 35 kg/m2
* Meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5), as established by a full psychiatric interview in conjunction with the Mini International Neuropsychiatric Interview (MINI)
* Documented diagnosis of schizophrenia for at least 1 year before screening
* Stable in terms of both positive and negative symptoms of schizophrenia over the last 3 months
* Score of \> 20 on the PANSS original negative symptoms subscale (Sum of N1+N2+N3+N4+N5+N6+N7) at Screening and Baseline (Day -1) AND \< 4 points absolute difference between the 2 visits
* Discontinued psychotropic medications without risk to their clinical status or safety by Baseline
* Female subject, if not of childbearing potential, must be a woman who is post-menopausal or permanently sterilized
* Female subject, if of childbearing potential, must test negative for pregnancy and must be using a double barrier contraceptive method
* Must be normal metabolizer for P450 CYP 2D6, defined as a subject that has at least one functional allele (eg, \*1, \*2 or \*35), as determined by study-specific genotyping test before the first drug dose is administered
* Has a caregiver or family member or health care personnel who can provide information towards assessment and support the subject in terms of compliance with the protocol
Exclusion Criteria:
* Current major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, or intellectual disability (intellectual developmental disorder diagnosed by age 14)
* PANSS item score of \> 4 on:
* P4 Excitement/Hyperactivity
* P6 Suspiciousness/persecution
* P7 Hostility
* G8 Uncooperativeness
* G14 Poor impulse control
* CDSS total score \> 6
* Score of ≥ 2 on any 2 of items 1, 2, or 3, or a score of ≥ 3 on item 4 of the Barnes Akathisia Rating Scale (BARS)
* Has had electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), or repetitive trans-cranial magnetic stimulation (r-TMS) within the 6 months prior to the Screening visit or who are scheduled for ECT, VNS, or r-TMS at any time during the study
* Positive urine drug screen for drugs of abuse
* Currently taking proton pump inhibitors (PPI)
* Current systemic infection (eg, Hepatitis B, Hepatitis C, human immunodeficiency virus \[HIV\], tuberculosis)
* Requires or may require concomitant treatment with any other medication likely to increase QT interval
* Requires medication inhibiting CYP2D6
* Safety laboratory results show one or more of the following: potassium \<3.4 mmol/L, or calcium \<2.07 mmol/L, or magnesium \<0.70 mmol/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06107803
Study Brief:
Protocol Section:
NCT06107803