Status:
COMPLETED
Study of CAD-9303 in Subjects With Schizophrenia
Lead Sponsor:
Cadent Therapeutics
Conditions:
Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study will consist of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts that will be randomized, double-blind, and placebo-controlled to assess the safety, tolerability, and p...
Detailed Description
This study will be conducted in two Parts. Part 1 will consist of Single Ascending Dose (SAD) cohorts that will be randomized, double-blind, and placebo-controlled to assess the safety, tolerability, ...
Eligibility Criteria
Inclusion
- Key
- For SAD Cohorts: able to tolerate washout from antipsychotic medications for the duration of the planned cohort.
- For MAD Cohorts: not taking an antipsychotic medication at screening and throughout participation in the study or taking one antipsychotic medication at least 6 weeks prior to screening and as a concomitant antipsychotic medication throughout participation in the study.
- Diagnosis of schizophrenia by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria with duration of illness \> 1 year since diagnosis.
- Clinical history of minimal, stable positive symptoms while under treatment with a stable psychotropic regimen.
- Key
Exclusion
- Abnormal findings on screening safety EEG or lifetime history of seizures or stroke.
- Meets current criteria of any psychiatric diagnosis other than schizophrenia, or lifetime history of any psychiatric diagnosis other than schizophrenia based upon the Mini International Neuropsychiatric Interview (MINI).
- Participants with moderate to severe extrapyramidal symptoms including tardive dyskinesia (Simpson-Angus Scale\>6, any Abnormal Involuntary Movement Scale (AIMS) Item 1-7 \>2), and akathisia (Barnes Akathisia Rating Scale \[BARS\] Item 4 ≥1).
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04306146
Start Date
February 28 2020
End Date
November 24 2021
Last Update
December 15 2021
Active Locations (2)
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1
Collaborative Neuroscience Research
Long Beach, California, United States, 90806
2
Hassman Research Institute
Marlton, New Jersey, United States, 08053