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Trial record 21 of 89 for:    CARBAMAZEPINE AND Psychotropic

A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00892125
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE November 20, 2008
First Posted Date  ICMJE May 4, 2009
Last Update Posted Date May 18, 2011
Study Start Date  ICMJE September 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
to evaluate the effects of a potent enzyme inducer, carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
to evaluate the safety and tolerability of the treatments in clinically stable patients with a diagnosis of schizophrenia or bipolar I disorder
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder
Official Title  ICMJE Evaluation of the Effect of Carbamazepine on the Steady-state Pharmacokinetics of Paliperidone Extended Release in Clinically Stable Subjects With Schizophrenia or Bipolar I Disorder
Brief Summary The purposes of this study are to evaluate the effects of a potent metabolic enzyme inducer, carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER and to evaluate the safety and tolerability of the treatments in clinically stable patients with a diagnosis of schizophrenia or bipolar I disorder.
Detailed Description The current study is designed as an open-label, multiple-center, multiple-dose, 2 treatment, 2 period sequential drug interaction study. It consists of 3 phases: a screening phase beginning within 21 days before the first study drug administration; an open label treatment phase consisting of 2 treatment periods (Period 1 and Period 2), during which patients will receive multiple oral doses of 6-mg paliperidone ER alone or in combination with multiple oral doses of carbamazepine, and end of study evaluations upon completion of all the study procedures in Period 2 or at early withdrawal. There is no washout period between treatment periods. Given the potential concomitant use of carbamazepine with antipsychotics, such as paliperidone ER, in the treatment of schizophrenia or bipolar I disorder, this study is designed to investigate the effect of carbamazepine on the steady-state pharmacokinetics of paliperidone ER. Safety and tolerability will be monitored throughout the study.. Period 1: 6 mg paliperidone ER once daily from Day 1 through Day 7, route oral; Period 2: 6 mg paliperidone ER once daily and carbamazepine 200 mg twice daily from Day 8 through Day 28, route oral.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Bipolar Disorder
Intervention  ICMJE Drug: paliperidone ER; Carbamazepine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2009)
64
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2009)
60
Actual Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of schizophrenia of any subtype (295.10
  • 295.20
  • 295.30
  • 295.60
  • 295.90) or bipolar I disorder (296.0x, 296.4x, 296.5x, 296.6x or 296.7), according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
  • Clinically stable with no psychiatric hospitalization or change in existing mood stabilizers, antipsychotic, or anti-manic drugs for 3 months before screening. A reduction in the dose of existing medication is acceptable if the subject remained clinically stable throughout the 3 month period. In addition, an increase or decrease in the dose of a mood stabilizer on the basis of therapeutic drug monitoring or the substitution of a specific mood stabilizer, antipsychotic, or anti-manic drug for another because of poor tolerability will be allowed within 3 months before screening
  • Have a CGI-S score of 3 or less at baseline and at screening
  • Body mass index (BMI, weight [kg]/height [m2]) of 18 to 35 kg/m2, inclusive
  • Have a supine (after 5 minutes rest) blood pressure between 100 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive
  • Apart from the above-mentioned diagnosis, otherwise healthy on the basis of a prestudy physical examination, medical history, 12-lead ECG, and the laboratory results of serum chemistry, hematology, and urinalysis performed within 21 days before the first dose. For renal function tests, the values must be within the normal laboratory reference ranges
  • Women must be postmenopausal for at least 2 years, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include intrauterine devices, double-barrier method, and male partner sterilization). Prescription hormonal contraceptives must be used in combination with another method of birth control (e.g., double-barrier method) throughout the study. Women of childbearing potential must have a negative serum pregnancy test result at screening, and a negative urine test at baseline (Day 1).

Exclusion Criteria:

  • Diagnosis of schizoaffective disorder (295.70) according to the DSM-IV
  • Meet DSM-IV criteria for rapid cycling
  • DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within 12 months before screening. Intermittent substance abuse in the months before screening will not be exclusionary, depending upon the clinical judgment of the investigator, with the exception of barbiturates
  • Acute substance abuse, as evidenced by a positive urine drug screen at screening or baseline (Day 1)
  • Positive alcohol test at screening or baseline (Day 1)
  • Current suicidal ideation or violent tendencies at the time of screening
  • Involuntarily-hospitalized subjects
  • Moderate or severe tardive dyskinesia at the time of screening
  • History of neuroleptic malignant syndrome
  • History of bone marrow depression or acute intermittent porphyria
  • History of or a positive result at screening for any of the serology tests (hepatitis B, C, and human immunodeficiency virus [HIV])
  • History or presence of any relevant cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00892125
Other Study ID Numbers  ICMJE CR011440
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date April 2010

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