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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01323205
First received: March 24, 2011
Last updated: May 22, 2014
Last verified: May 2014

March 24, 2011
May 22, 2014
May 2011
November 2012   (final data collection date for primary outcome measure)
  • Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • The number of patients with abnormal results from electrocardiograms (ECGs) performed as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of patients with adverse events reported as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01323205 on ClinicalTrials.gov Archive Site
  • Positive and Negative Syndrome Scale (PANSS) scores to explore potential therapeutic effect of study drug [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Global Impression - Schizophrenia (CGI-SCH) ratings to explore potential therapeutic effect of study drug [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Subjective Well-being under Neuroleptics Scale (SWN) scores to explore potential therapeutic effect of study drug [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Plasma (blood) concentration of JNJ-40411813 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Bulgaria,   Germany,   Romania,   Spain
 
NCT01323205
CR018340, 40411813SCH2001, 2010-023369-23
No
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
May 2014

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