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

NCT01323205 | Completed Phase 2

• 3 other identifiers: CR01834040411813SCH20012010-023369-23
• Study Type: interventional
• Target: 100
• Locations: 6 countries
• Sites: 20

Brief Summary

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

Conditions

Schizophrenia

Keywords

JNJ-40411813

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (3)

JNJ-40411813 (Part A)

EXPERIMENTAL

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 (Part B)

EXPERIMENTAL

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; Drug: Antipsychotic medication

Placebo and JNJ-40411813 (Part B)

EXPERIMENTAL

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; Drug: Placebo; Drug: Antipsychotic medication

Interventions

JNJ-40411813 DRUG

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 (Part A)

Placebo DRUG

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

Placebo and JNJ-40411813 (Part B)

Antipsychotic medication DRUG

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.

JNJ-40411813 (Part B); Placebo and JNJ-40411813 (Part B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (20)

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Salzburg, Austria

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Dave, Belgium

Location

Unknown Facility

Duffel, Belgium

Location

Unknown Facility

Kortenberg, Belgium

Location

Unknown Facility

Lede, Belgium

Location

Unknown Facility

Plovdiv, Bulgaria

Location

Unknown Facility

Radnevo, Bulgaria

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

Mannheim, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Arad, Romania

Location

Unknown Facility

Brasov, Romania

Location

Unknown Facility

Iași, Romania

Location

Unknown Facility

Sibiu, Romania

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Zamora, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

1-butyl-3-chloro-4-(4-phenyl-1-piperidinyl)-(1H)-pyridone; Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Janssen Research & Development, LLC C. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 30, 2014

Record last verified: 2014-05

Locations

RO (4); ES (2); BE (4); AU (3); BU (2); DE (5)