The Effect of JNJ-39393406 on Event Related Potentials in Stable Schizophrenic Patients

This study has been terminated.
(Efficacy signals were insufficiently strong to justify recruitment of additional patients.)
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT01137799
First received: June 3, 2010
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Alzheimer's Disease
Cognition Disorders
Drug: JNJ-39393406
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Four-Way Cross-Over Study To Investigate Effect Of Single Oral Doses Of JNJ-39393406 On Event-Related Potentials In Subjects With Stable Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:
  • Improvement of deficits (i.e. sensory gating deficits) in event related potentials like Auditory Evoked Potentials P50 and P300 and Mismatch Negativity. [ Time Frame: Predose and 2 and 5 hours post dose during each treatment period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in continuous performance testing [ Time Frame: Predose, 2h and 5 post dosing during each treatment period ] [ Designated as safety issue: No ]
  • Plasma concentrations of JNJ-39393406 (PK blood samples) [ Time Frame: Predose, 1h, 1h45, 3h, 4h45 and 6h postdose during each treatment period ] [ Designated as safety issue: No ]
  • Number of patients with clinical significant changes in vitals signs [ Time Frame: Baseline, predose and 6h post dose during each treatment period and follow up visit. ] [ Designated as safety issue: No ]
  • Number of patients with clinical significant changes in ECG parameters [ Time Frame: baseline, predose and 6h post dose during each treatment period and follow up ] [ Designated as safety issue: No ]
  • Number of patients with clinical clinical significant changes in clinical laboratory parameters [ Time Frame: baseline, predose and 6h post dose during each treatment period and Follow Up ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: August 2009
Study Completion Date: March 2011
Arms Assigned Interventions
Experimental: 001
JNJ-39393406 10mg nanosuspension (sort of liquid formulation) once daily (single dose)
Drug: JNJ-39393406
10mg nanosuspension (sort of liquid formulation) once daily (single dose)
Experimental: 002
JNJ-39393406 30mg nanosuspension (sort of liquid formulation) once daily (single dose)
Drug: JNJ-39393406
30mg nanosuspension (sort of liquid formulation) once daily (single dose)
Experimental: 003
JNJ-39393406 50mg nanosuspension (sort of liquid formulation) once daily (single dose)
Drug: JNJ-39393406
50mg nanosuspension (sort of liquid formulation) once daily (single dose)
Experimental: 004
JNJ-39393406 100mg nanosuspension (sort of liquid formulation) once daily (single dose)
Drug: JNJ-39393406
100mg nanosuspension (sort of liquid formulation) once daily (single dose)
Experimental: 005
JNJ-39393406 200mg nanosuspension (sort of liquid formulation) once daily (single dose)
Drug: JNJ-39393406
200mg nanosuspension (sort of liquid formulation) once daily (single dose)
Placebo Comparator: 006
placebo Once daily (single dose)
Drug: placebo
Once daily (single dose)

Detailed Description:

This is a double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, randomized (study drug assigned by chance), four-way-crossover trial (participants may receive different interventions sequentially during the trial) in patients with stable schizophrenia. The four-way-crossover treatment phase will consist of four blinded treatment periods separated by a wash out period (the period allowed for the entire administered drug to be eliminated from the body) of 6 to 14 days. The study duration for each patient will be approximately 12 weeks. Each patient enrolled will receive 3 (out of 5) dose levels of JNJ-39393406 and one dose of placebo. Part A of the study will include smoking patients with schizophrenia and will precede part B which will include non-smoking patients with schizophrenia. Safety evaluations include adverse event monitoring, vital signs and clinical laboratory tests. The study drug will be given as a single dose on Day 1 of each treatment period as a kind of liquid formulation with 240 mL non-carbonated water between 7:00 AM and 10:30 AM. Before dosing patients will be given a standard breakfast. The proposed dose levels for this study (Part A and Part B) will range from 10 to 200 mg.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 DNA storage component (Part 2) is voluntary and refusal to participate will not result in ineligibility for the main part of the study

Exclusion Criteria:

  • A DSM-IV axis I diagnosis other than schizophrenia
  • Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening or admission. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable. Values of ALT/AST < 2 fold the upper limit of normal will be allowed
  • Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable
  • QTcb >470ms
  • A DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (caffeine dependence is not exclusionary. Patients with a positive drug screen at screening may be included provided use does not lead to a DSM-IV diagnosis of substance dependence and patients consents to abstain from illegal drugs within 3 days prior to Day -1 and at any time during the study)
  • Treatment-resistant subjects (failure to respond to two different antipsychotic drugs in the past)
  • PANSS scores > 70
  • Suicidal risk (assessed by the investigator such as, prior attempts to suicide, command hallucinations and / or hopelessness)
  • Use of clozapine within 3 months before screening until follow-up
  • Use of more than two antipsychotic drugs within 3 months before dosing until follow up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137799

Locations
Germany
Berlin, Germany
Erlangen, Germany
München, Germany
Neuss, Germany
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
  More Information

No publications provided by Janssen Pharmaceutica N.V., Belgium

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT01137799     History of Changes
Other Study ID Numbers: CR016762
Study First Received: June 3, 2010
Last Updated: November 7, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
symptomatic treatment
cognition
cognitive deficits
schizophrenia
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Schizophrenia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 28, 2014