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SchizophreniaPhase 1NCT01137799

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

A Phase 1 study testing JNJ-39393406 in people with Schizophrenia and Alzheimer's Disease, run by Janssen Pharmaceutica N.V., Belgium at 4 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men only
What is being tested?
JNJ-39393406
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
4 sitesGermany
Study dates
Aug 2009to Mar 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Study site

    Berlin

  • Study site

    Erlangen

  • Study site

    München

  • Study site

    Neuss

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
JNJ-39393406, placebo
Keywords
symptomatic treatment, cognition, cognitive deficits, schizophrenia, Alzheimer's Disease
Medical subject headings
Schizophrenia, Alzheimer Disease, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-39393406Drug

    50mg nanosuspension (sort of liquid formulation) once daily (single dose)

  • placeboDrug

    Once daily (single dose)

  • JNJ-39393406Drug

    200mg nanosuspension (sort of liquid formulation) once daily (single dose)

  • JNJ-39393406Drug

    100mg nanosuspension (sort of liquid formulation) once daily (single dose)

  • JNJ-39393406Drug

    10mg nanosuspension (sort of liquid formulation) once daily (single dose)

  • JNJ-39393406Drug

    30mg nanosuspension (sort of liquid formulation) once daily (single dose)

Study groups in NCT01137799
Study groupRoleWhat they receive
001ExperimentalJNJ-39393406 10mg nanosuspension (sort of liquid formulation) once daily (single dose)
Receives: Drug: JNJ-39393406
002ExperimentalJNJ-39393406 30mg nanosuspension (sort of liquid formulation) once daily (single dose)
Receives: Drug: JNJ-39393406
003ExperimentalJNJ-39393406 50mg nanosuspension (sort of liquid formulation) once daily (single dose)
Receives: Drug: JNJ-39393406
004ExperimentalJNJ-39393406 100mg nanosuspension (sort of liquid formulation) once daily (single dose)
Receives: Drug: JNJ-39393406
005ExperimentalJNJ-39393406 200mg nanosuspension (sort of liquid formulation) once daily (single dose)
Receives: Drug: JNJ-39393406
006Placebo comparatorplacebo Once daily (single dose)
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of deficits (i.e. sensory gating deficits) in event related potentials like Auditory Evoked Potentials P50 and P300 and Mismatch Negativity.

    Measured: Predose and 2 and 5 hours post dose during each treatment period.

Secondary outcomes (5)

  1. Improvement in continuous performance testing

    Measured: Predose, 2h and 5 post dosing during each treatment period

  2. Plasma concentrations of JNJ-39393406 (PK blood samples)

    Measured: Predose, 1h, 1h45, 3h, 4h45 and 6h postdose during each treatment period

  3. Number of patients with clinical significant changes in vitals signs

    Measured: Baseline, predose and 6h post dose during each treatment period and follow up visit.

  4. Number of patients with clinical significant changes in ECG parameters

    Measured: baseline, predose and 6h post dose during each treatment period and follow up

  5. Number of patients with clinical clinical significant changes in clinical laboratory parameters

    Measured: baseline, predose and 6h post dose during each treatment period and Follow Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2010 (estimated)
  2. Study startAug 2009
  3. Study completionMar 2011

Why it stopped: Efficacy signals were insufficiently strong to justify recruitment of additional patients.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01137799
Sponsor's protocol ID
CR016762
Status last verified
Nov 2012
First submitted
3 Jun 2010
Last updated
8 Nov 2012
Results posted
No
Data monitoring committee
No

Publications

  • Winterer G, Gallinat J, Brinkmeyer J, Musso F, Kornhuber J, Thuerauf N, Rujescu D, Favis R, Sun Y, Franc MA, Ouwerkerk-Mahadevan S, Janssens L, Timmers M, Streffer JR. Allosteric alpha-7 nicotinic receptor modulation and P50 sensory gating in schizophrenia: a proof-of-mechanism study. Neuropharmacology. 2013 Jan;64:197-204. doi: 10.1016/j.neuropharm.2012.06.040. Epub 2012 Jul 2.

    PubMed 22766391

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-39393406 in people with Schizophrenia and Alzheimer's Disease, run by Janssen Pharmaceutica N.V., Belgium at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Efficacy signals were insufficiently strong to justify recruitment of additional patients.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01137799, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2012.

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