Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00101634
First received: January 12, 2005
Last updated: June 6, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate 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.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone palmitate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq, 50 mg eq, and 100 mg eq) of Paliperidone Palmitate in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Change in total PANSS score from baseline to the end of the double blind treatment period.

Secondary Outcome Measures:
  • PSP and CGI-S scores from baseline to the end of of the double-blind treatment. Incidence of adverse events, labs and ECGs throughout study.

Enrollment: 518
Study Start Date: December 2004
Study Completion Date: March 2006
Detailed Description:

Many patients with schizophrenia have difficulty adhering to a daily oral treatment regimen. Long-acting injectable (LAI) formulations may provide therapeutic plasma concentrations over several weeks, thereby eliminating the need for daily oral medication and making compliance easier. 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, parallel group, multicenter, dose-response study in adults who have schizophrenia. The study consists of a screening period of no more than 7 days and a 13-week double-blind treatment period. The screening period includes 4 days for tolerability testing, if necessary. In the double-blind treatment period, patients will be randomly assigned to 1 of 4 treatment groups (3 fixed doses of paliperidone palmitate or placebo) to receive 4 i.m. injections of paliperidone palmitate or placebo on Days 1, 8, 36, and 64. The study, including the screening period, will last approximately 14 weeks. Efficacy will be assessed throughout the study using the Positive and Negative Symptom Scale for Schizophrenia (PANSS), the Clinical Global Impression-Severity (CGI-S), and the Personal and Social Performance Scale (PSP). Safety will be evaluated throughout the study by monitoring adverse events, extrapyramidal symptom (EPS) rating scales scores, clinical laboratory test results; vital signs and body weight measurements; electrocardiograms (ECGs); and physical examination findings. In addition, the tolerability of injections will be assessed. ER OROS paliperidone 3 mg/day for 4 days. Injections (i.m.) of paliperidone palmitate (25, 50, or 100 mg eq.) will be given on Days 1, 8, 36, and 64.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who meet diagnostic criteria for schizophrenia according to DSM-IV for at least 1 year
  • meet PANSS score criteria
  • have body mass index (BMI) of >15.0 kilogram(kg)/meter (m)2.

Exclusion Criteria:

  • Patients who have primary active DSM-IV Axis I diagnosis other than schizophrenia
  • have a decrease of >/=25% in the PANSS score
  • have DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation (nicotine and caffeine dependence are not exclusionary)
  • have history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
  • have any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
  • have significant risk of suicidal, homicidal or violent ideation or behavior
  • current presence of any significant or unstable medication condition
  • treatment with any protocol disallowed therapies
  • clinically significant result from screening laboratory or ECG.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101634

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00101634     History of Changes
Other Study ID Numbers: CR003562
Study First Received: January 12, 2005
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
Paliperidone palmitate
R092670
antipsychotic

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2014