CVN058 Effect on Mismatch Negativity in Schizophrenics

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This is a phase 1, double-blind, placebo-controlled, 3 period cross-over study to evaluate CVN058 target engagement by measuring auditory evoked potential mismatch negativity (MMN) downstream to 5-hydroxytryptamine receptor 3 (5-HT3) as a pharmacodynamic (PD) marker.

Key facts

Study ID

NCT03669250

Run by

Cerevance Alpha, Inc.

People needed

22

Starts

2018-11-09

Expected to finish

2020-03-06

Last updated by the study team

2024-10-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects 18 to 50 years of age, inclusive, at the time of informed consent.
• The subject weighs at least 50 kg and has a body mass index (BMI) between 18 and 40 kg/m2 inclusive at Screening.
• Subject meets schizophrenia criteria as defined by the Diagnostic \& Statistical Manual of mental Disorders, 5th Edition (DSM-V).
• Subjects are on a stable dose of antipsychotic medication(s) for at least 2 months prior to - Screening as documented by medical history and assessed by site staff.
• Subject has a Positive and Negative Syndrome Scale (PANSS) total score of <95.

You may not qualify if…

• Subject currently receiving treatment with any excluded medication or dietary supplement.
• Subjects who have a history of gastrointestinal disease that would influence the absorption of study drug or have a history of any surgical intervention known to impact absorption (e.g., bariatric surgery or bowel resection).
• Subjects having clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) outside the reference range for the testing laboratory, unless the results are deemed to be not clinically significant (NCS) by the investigator at Screening.
• Subjects with moderate to severe substance use disorder, unstable mood or anxiety disorder.
• Subject has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/episode.
• Subject has clinically meaningful hearing loss.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• New York State Psychiatric Institute — New York, New York, United States
• Nathan Kline Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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