The Effect of JNJ-39393406 on Event Related Potentials in Stable Schizophrenic Patients (NCT01137799) | Clinical Trial Compass
TerminatedPhase 1
The Effect of JNJ-39393406 on Event Related Potentials in Stable Schizophrenic Patients
Stopped: Efficacy signals were insufficiently strong to justify recruitment of additional patients.
Germany47 participantsStarted 2009-08
Plain-language summary
This study in patients with stable schizophrenia will investigate the effect of JNJ-39393406 on Event Related Potentials (Auditory Evoked Potential \[AEP\] P50, AEP P300 and Mismatch Negativity \[MMN\]) after single dose administration.
Who can participate
Age range18 Years – 55 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male between 18 and 55 years of age, inclusive
* A known history of schizophrenia of at least 12 months by the referring psychiatrist
* DSM-IV criteria for Schizophrenia (including all subtypes)
* Stable treatment for at least 3 months (minor changes are acceptable upon confirmation by the sponsor representative)
* Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population
* Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject source documents and initialed by the investigator
* BMI between 18 and 35 kg/m² inclusive (BMI = weight/height²)
* For the pharmacogenomic component of this study subjects must have signed a separate written informed consent indicating willingness to participate in Part 1 genetic testing (mandatory), and indicate either consent or refusal for Part 2 DNA storage. Subject participation in the genetic testing component of the study (Part 1) is mandatory. Participation in the …
What they're measuring
1
Improvement of deficits (i.e. sensory gating deficits) in event related potentials like Auditory Evoked Potentials P50 and P300 and Mismatch Negativity.
Timeframe: Predose and 2 and 5 hours post dose during each treatment period.