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SchizophreniaPhase 2NCT01323205

Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia

A Phase 2 study testing JNJ-40411813 and Antipsychotic medication in people with Schizophrenia, run by Janssen Research & Development, LLC at 20 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to explore the safety, tolerability, and potential clinical efficacy of JNJ 40411813 in schizophrenic patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
JNJ-40411813 and Antipsychotic medication
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
20 sitesin 6 countries
Study dates
May 2011to Dec 2012
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive
  • Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG and clinical laboratory tests
  • In- or outpatients who have been diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) at least 1 year prior to screening.

Who cannot join

  • A current DSM-IV axis I diagnosis other than schizophrenia
  • Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
  • Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disorders), renal, hepatic, endocrine, or immunologic diseases
  • PANSS score <50 or >120
  • Other significant and/or unstable systemic illnesses

Trial locations and contacts

20 sites in 6 countries.

20 sites in 6 countries

Germany5 sites

  • Study site

    Berlin

  • Study site

    Hamburg

  • Study site

    Mainz

  • Study site

    Mannheim

  • Study site

    München

Other trials in Germany

Belgium4 sites

  • Study site

    Dave

  • Study site

    Duffel

  • Study site

    Kortenberg

  • Study site

    Lede

Other trials in Belgium

Romania4 sites

  • Study site

    Arad

  • Study site

    Brasov

  • Study site

    Iași

  • Study site

    Sibiu

Other trials in Romania

Austria3 sites

  • Study site

    Innsbruck

  • Study site

    Salzburg

  • Study site

    Vienna

Other trials in Austria

Bulgaria2 sites

  • Study site

    Plovdiv

  • Study site

    Radnevo

Other trials in Bulgaria

Spain2 sites

  • Study site

    Barcelona

  • Study site

    Zamora

Other trials in Spain

About this study

Official title: First-in-Patient Study to Assess the Safety and Tolerability and to Explore the Potential Therapeutic Efficacy of a Novel Glutamate Modulator as Monotherapy and as Add-On Therapy in Patients With Schizophrenia

The purpose of this study is to explore the safety, tolerability, and potential clinical efficacy of JNJ 40411813 in schizophrenic patients.

Read the detailed description

This is a first-in-human study of JNJ-40411813 in schizophrenic patients who are not currently receiving antipsychotic drug treatment (referred to as "(sub) acute" patients) and in patients who are currently taking antipsychotic drug treatment (referred to as "stable" patients). The study will consist of 2 parts: Part A and Part B. Part A will be open-label (patients will know the identity of study treatment), and (sub)acute schizophrenic patients will receive monotherapy (treatment with one drug) with JNJ-40411813. Part B will be double-blind (patient and study staff will not know the identity of study treatment) and will randomize (assign by chance) patients with stable but symptomatic schizophrenia to receive treatment with JNJ-40411813 or a placebo (treatment identical in appearance to JNJ-40411813 but does not contain active drug) as add-on therapy to their currently prescribed antipsychotic medication. Parts A (JNJ-40411813 monotherapy) and B (JNJ-40411813 add-on therapy) will run simultaneously. Patients will take JNJ-40411813 and placebo capsules orally (by mouth) twice daily (bid) with a meal. Part A: Patients will take JNJ-40411813 50 mg (1 capsule) bid up to 150 mg (3 capsules) bid for up to 12 weeks. Part B: Patients will take JNJ-40411813 50 mg bid or placebo bid for 4 weeks. After 4 weeks, the dose of JNJ-40411813 may be increased up to 150 mg bid for 6 weeks, and patients assigned to placebo may take JNJ-40411813 50 mg bid to 150 mg bid for up to 10 weeks.

Conditions
Schizophrenia
Being tested
JNJ-40411813, Placebo, Antipsychotic medication
Keywords
JNJ-40411813
Medical subject headings
Schizophrenia

What participants receive

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

  • JNJ-40411813Drug

    JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 12 weeks.

  • JNJ-40411813Drug

    JNJ-40411813 starting dose from 50 to 150 mg as an add-on therapy. Dose is increased step-wise from 50 mg to 150 mg. Capsule(s) taken by mouth twice daily with a meal for 10 weeks.

  • PlaceboDrug

    Placebo capsule (s) orally twice daily with a meal for 4 weeks.

  • Antipsychotic medicationDrug

    Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol Hydrochloride, Clotiapine, Pipamperone Hydrochloride, Benperidol, Flupentixol, Fluphenazine Decanoate, Melperone Hydrochloride, or Chlorpromazine Hydrochloride) will be continued in Part B.

Study groups in NCT01323205
Study groupRoleWhat they receive
JNJ-40411813 (Part A)ExperimentalJNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 12 weeks.
Receives: Drug: JNJ-40411813
JNJ-40411813 (Part B)ExperimentalJNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 10 weeks.
Receives: Drug: JNJ-40411813; Drug: Antipsychotic medication
Placebo and JNJ-40411813 (Part B)ExperimentalPlacebo capsule (s) orally twice daily with a meal for 4 weeks followed by JNJ-40411813 according to tolerability dose range increased from 50 mg to 150 mg twice daily with a meal to 6 weeks.
Receives: Drug: JNJ-40411813; Drug: Placebo; Drug: Antipsychotic medication

What is being measured

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

  1. Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients

    Measured: Up to 12 weeks

  2. The number of patients with abnormal results from clinical laboratory tests performed as a measure of safety and tolerability

    Measured: Up to 12 weeks

  3. The number of patients with abnormal results from electrocardiograms (ECGs) performed as a measure of safety and tolerability

    Measured: Up to 12 weeks

  4. The number of patients with abnormal results from physical examinations (including vital signs measurements) performed as a measure of safety and tolerability

    Measured: Up to 12 weeks

  5. Number of patients with adverse events reported as a measure of safety and tolerability

    Measured: Up to 12 weeks

Secondary outcomes (4)

  1. Positive and Negative Syndrome Scale (PANSS) scores to explore potential therapeutic effect of study drug

    Measured: Up to 12 weeks

  2. Clinical Global Impression - Schizophrenia (CGI-SCH) ratings to explore potential therapeutic effect of study drug

    Measured: Up to 12 weeks

  3. Subjective Well-being under Neuroleptics Scale (SWN) scores to explore potential therapeutic effect of study drug

    Measured: Up to 12 weeks

  4. Plasma (blood) concentration of JNJ-40411813

    Measured: Up to 12 weeks

Timeline

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

  1. First posted25 Mar 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionNov 2012
  4. Study completionDec 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01323205
Sponsor's protocol ID
CR018340
Other IDs
40411813SCH2001, 2010-023369-23
Status last verified
May 2014
First submitted
24 Mar 2011
Last updated
30 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-40411813 and Antipsychotic medication in people with Schizophrenia, run by Janssen Research & Development, LLC at 20 sites in 6 countries.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany, Belgium, Romania, Austria, Bulgaria and 1 more country. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients (time frame: Up to 12 weeks). The study lists 5 primary outcomes in all. 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 NCT01323205.

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 30 May 2014.

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