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
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: JNJ-40411813
Drug: Placebo
Drug: Antipsychotic medication
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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: 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: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01323205

Locations
Austria
Innsbruck, Austria
Salzburg, Austria
Wien, Austria
Belgium
Dave, Belgium
Duffel, Belgium
Kortenberg, Belgium
Lede, Belgium
Bulgaria
Plovdiv, Bulgaria
Radnevo N/A, Bulgaria
Germany
Berlin, Germany
Hamburg, Germany
Mainz, Germany
Mannheim, Germany
München, Germany
Romania
Arad, Romania
Brasov, Romania
Iasi, Romania
Sibiu, Romania
Spain
Barcelona, Spain
Zamora, Spain
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01323205     History of Changes
Other Study ID Numbers: CR018340, 40411813SCH2001, 2010-023369-23
Study First Received: March 24, 2011
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission
Spain: Spanish Agency of Medicines

Keywords provided by Janssen Research & Development, LLC:
JNJ-40411813

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014