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Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00074477
Recruitment Status : Completed
First Posted : December 15, 2003
Last Update Posted : May 24, 2011
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE December 12, 2003
First Posted Date  ICMJE December 15, 2003
Last Update Posted Date May 24, 2011
Study Start Date  ICMJE October 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
The change in total PANSS score from the start of the double-blind treatment period to the end of the double-blind treatment period.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00074477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
Changes from the start of to the end of the double-blind treatment period in CGI-S and in the PANSS subscales for specific symptoms. Incidence of adverse events, labs and ECGs throughout study.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 50 and 100 Mg-eq of Paliperidone Palmitate in Patients With Schizophrenia
Brief Summary The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate injection compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.
Detailed Description Paliperidone palmitate is an aqueous suspension that releases paliperidone gradually over a period of about 1 month and is under development to provide a sustained and stable level of paliperidone. This is a randomized (patients will be assigned to different treatment groups based solely on chance), double-blind (neither the patient nor the physician will know if placebo or drug is being given and at what dose), placebo-controlled, multicenter study in patients with schizophrenia. The study consists of a screening period (maximum 5 days, including a 3-day washout of psychotropic medications other than antidepressants, if applicable); a 7-day, open-label, oral run-in period; and a 64-day double-blind treatment period. The total duration of the study is approximately 11 weeks. Efficacy will be evaluated during the study using the Positive and Negative Symptom Scale for Schizophrenia (PANSS) and the Clinical Global Impression - Severity (CGI-S) scale. Safety will be evaluated by monitoring adverse events and changes in clinical laboratory results, including prolactin levels; physical examination results; tardive dyskinesia will be rated using the Abnormal Involuntary Movement Scale (AIMS), akathisia will be rated according to the Barnes Akathisia Rating Scale (BARS), extrapyramidal symptoms will be evaluated using the Simpson-Angus Rating Scale (SAS); electrocardiogram (ECG); vital sign measurements; and concomitant therapy. ER OROS paliperidone (6 or 12 mg) or IR paliperidone (2 or 4 mg) oral dosage administered daily for 7 days (Day -7 to -1), followed by i.m. injections of paliperidone palmitate (either 50 mg eq. or 100 mg eq.), or placebo on Days 1, 8, and 36 of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: R092670
Study Arms  ICMJE Not Provided
Publications * Kramer M, Litman R, Hough D, Lane R, Lim P, Liu Y, Eerdekens M. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol. 2010 Jun;13(5):635-47. doi: 10.1017/S1461145709990988. Epub 2009 Nov 27.

*   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: August 28, 2009)
250
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
210
Actual Study Completion Date  ICMJE July 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed with schizophrenia
  • for at least 1 year before screening
  • meet PANSS score criteria
  • must agree to hospitalization for a minimum of 14 days
  • body mass index (BMI) <35.0 kilogram (kg)/meter (m)2.

Exclusion Criteria:

  • Patients who are involuntarily committed as in-patients
  • have a DSM-IV Axis I diagnosis other than schizophrenia
  • have a DSM-IV diagnosis of substance dependence within 3 months before screening (nicotine, caffeine dependence, and history of recreational use of marijuana are not exclusionary)
  • have a decrease of >/=25% in the PANSS score between screening and predose
  • previous lack of response to 2 adequate trials of antipsychotic treatment
  • have a significant risk of suicidal, homicidal, or violent ideation or behavior
  • have severe gastrointestinal narrowing (pathologic or iatrogenic)
  • current presence of any significant or unstable medication condition
  • treatment with any protocol disallowed therapies
  • clinically significant result from screening laboratory or ECG.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 Bulgaria,   India,   Poland,   Russian Federation,   Ukraine,   United States
 
Administrative Information
NCT Number  ICMJE NCT00074477
Other Study ID Numbers  ICMJE CR004357
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