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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01323205

Collaborator

(none)

100

Enrollment

Locations

Arms

19.1

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: JNJ-40411813 Drug: JNJ-40411813 Drug: Placebo Drug: Antipsychotic medication	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Experimental: JNJ-40411813 (Part B)

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

Outcome Measures

Primary Outcome Measures

Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients [Up to 12 weeks]
The number of patients with abnormal results from clinical laboratory tests performed as a measure of safety and tolerability [Up to 12 weeks]
The number of patients with abnormal results from electrocardiograms (ECGs) performed as a measure of safety and tolerability [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 [Up to 12 weeks]
Number of patients with adverse events reported as a measure of safety and tolerability [Up to 12 weeks]

Secondary Outcome Measures

Positive and Negative Syndrome Scale (PANSS) scores to explore potential therapeutic effect of study drug [Up to 12 weeks]
Clinical Global Impression - Schizophrenia (CGI-SCH) ratings to explore potential therapeutic effect of study drug [Up to 12 weeks]
Subjective Well-being under Neuroleptics Scale (SWN) scores to explore potential therapeutic effect of study drug [Up to 12 weeks]
Plasma (blood) concentration of JNJ-40411813 [Up to 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	Country
1	Innsbruck	Austria
2	Salzburg	Austria
3	Wien	Austria
4	Dave	Belgium
5	Duffel	Belgium
6	Kortenberg	Belgium
7	Lede	Belgium
8	Plovdiv	Bulgaria
9	Radnevo N/A	Bulgaria
10	Berlin	Germany
11	Hamburg	Germany
12	Mainz	Germany
13	Mannheim	Germany
14	München	Germany
15	Arad	Romania
16	Brasov	Romania
17	Iasi	Romania
18	Sibiu	Romania
19	Barcelona	Spain
20	Zamora	Spain

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC C. Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT01323205

Other Study ID Numbers:

CR018340
40411813SCH2001
2010-023369-23

First Posted:

Mar 25, 2011

Last Update Posted:

May 30, 2014

Last Verified:

May 1, 2014

Keywords provided by Janssen Research & Development, LLC

JNJ-40411813

Additional relevant MeSH terms:

Schizophrenia

Antipsychotic Agents

Study Results

No Results Posted as of May 30, 2014