A Positron Emission Tomography Study of SLV354 in Healthy Subjects and Subjects With Schizophrenia

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

This open-label, Phase 1 study will investigate the 5-hydroxytryptamine 6 (5-HT6) receptor occupancy in the brain using positron emission tomography (PET) following single oral doses of SLV354. Up to 22 healthy male subjects and male subjects with stable schizophrenia, between 18-55 years of age are to complete the study.

Key facts

Study ID

NCT01545310

Run by

Abbott

People needed

18

Starts

2011-05-01

Expected to finish

2012-07-01

Last updated by the study team

2012-09-18

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male, age between 18 and 55 years, inclusive.
• Body Mass Index 18 to 30 (healthy) and 18 to 38 (schizophrenia).
• A condition of general good physical health.
• Schizophrenia subjects must have a diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR).
• Schizophrenia subjects must be on a stable dose of an atypical antipsychotic for at least 4 weeks prior to Screening.

You may not qualify if…

• Presence of a metal implant that would preclude a Magnetic Resonance Imaging (MRI) scan.
• Radiation exposure for research purposes within the past year that will exclude participation in the study.
• Significant current suicidal ideation within the past month as evidenced by Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening.
• History of psychiatric diseases or disorders (healthy subjects)
• Unsuitable to receive SLV354 or the radiotracer, [11C]-QUICS.

Where it is running

• Site Reference ID/Investigator# 52162 — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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