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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01323205
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE March 24, 2011
First Posted Date  ICMJE March 25, 2011
Last Update Posted Date May 30, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2011)
  • Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients [ Time Frame: Up to 12 weeks ]
  • The number of patients with abnormal results from clinical laboratory tests performed as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ]
  • The number of patients with abnormal results from electrocardiograms (ECGs) performed as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ]
  • The number of patients with abnormal results from physical examinations (including vital signs measurements) performed as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ]
  • Number of patients with adverse events reported as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
  • Number of patients with adverse events reported as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ]
  • Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients [ Time Frame: Up to 12 weeks ]
  • The number of patients with abnormal results from clinical laboratory tests performed as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ]
  • The number of patients with abnormal results from electrocardiograms (ECGs) performed as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ]
  • The number of patients with abnormal results from physical examinations (including vital signs measurements) performed as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
  • Positive and Negative Syndrome Scale (PANSS) scores to explore potential therapeutic effect of study drug [ Time Frame: Up to 12 weeks ]
  • Clinical Global Impression - Schizophrenia (CGI-SCH) ratings to explore potential therapeutic effect of study drug [ Time Frame: Up to 12 weeks ]
  • Subjective Well-being under Neuroleptics Scale (SWN) scores to explore potential therapeutic effect of study drug [ Time Frame: Up to 12 weeks ]
  • Plasma (blood) concentration of JNJ-40411813 [ Time Frame: Up to 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia
Official Title  ICMJE 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
Brief Summary The purpose of this study is to explore the safety, tolerability, and potential clinical efficacy of JNJ 40411813 in schizophrenic patients.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: JNJ-40411813
    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.
  • Drug: JNJ-40411813
    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.
  • Drug: Placebo
    Placebo capsule (s) orally twice daily with a meal for 4 weeks.
  • Drug: Antipsychotic medication
    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 Arms  ICMJE
  • Experimental: JNJ-40411813 (Part A)
    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.
    Intervention: Drug: JNJ-40411813
  • Experimental: JNJ-40411813 (Part B)
    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 10 weeks.
    Interventions:
    • Drug: JNJ-40411813
    • Drug: Antipsychotic medication
  • Experimental: Placebo and JNJ-40411813 (Part B)
    Placebo 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.
    Interventions:
    • Drug: JNJ-40411813
    • Drug: Placebo
    • Drug: Antipsychotic medication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2013)
100
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Bulgaria,   Germany,   Romania,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01323205
Other Study ID Numbers  ICMJE CR018340
40411813SCH2001 ( Other Identifier: Janssen Research & Development, LLC )
2010-023369-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP