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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323205
• Other study ID #: CR018340
• Secondary ID: 40411813SCH20012
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2011
• Last updated: May 22, 2014
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Ethics CommissionSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Germany,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients		Up to 12 weeks	Yes
Primary	The number of patients with abnormal results from clinical laboratory tests performed as a measure of safety and tolerability		Up to 12 weeks	Yes
Primary	The number of patients with abnormal results from electrocardiograms (ECGs) performed as a measure of safety and tolerability		Up to 12 weeks	Yes
Primary	The number of patients with abnormal results from physical examinations (including vital signs measurements) performed as a measure of safety and tolerability		Up to 12 weeks	Yes
Primary	Number of patients with adverse events reported as a measure of safety and tolerability		Up to 12 weeks	Yes
Secondary	Positive and Negative Syndrome Scale (PANSS) scores to explore potential therapeutic effect of study drug		Up to 12 weeks	Yes
Secondary	Clinical Global Impression - Schizophrenia (CGI-SCH) ratings to explore potential therapeutic effect of study drug		Up to 12 weeks	Yes
Secondary	Subjective Well-being under Neuroleptics Scale (SWN) scores to explore potential therapeutic effect of study drug		Up to 12 weeks	Yes
Secondary	Plasma (blood) concentration of JNJ-40411813		Up to 12 weeks	No