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An Efficacy and Safety Study of Long-acting Risperidone in Participants With Schizophrenia or Schizoaffective Disorders Who Are Receiving Psychiatric Home Care Treatment

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ClinicalTrials.gov Identifier: NCT00526877
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd

Tracking Information
First Submitted Date  ICMJE September 6, 2007
First Posted Date  ICMJE September 10, 2007
Last Update Posted Date February 28, 2014
Study Start Date  ICMJE July 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Change From Baseline in Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24 [ Time Frame: Baseline and Week 24 ]
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2007)
The mean change in total PANSS (Positive and Negative Syndrome Scale score) at endpoint versus baseline.
Change History Complete list of historical versions of study NCT00526877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
  • Personal and Social Performance (PSP) Scale Score [ Time Frame: Screening (28 days before study drug administration), Baseline and Week 24 ]
    The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.
  • Clinical Global Impression (CGI) Scale Score [ Time Frame: Screening (28 days before study drug administration), Baseline and Week 24 ]
    The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening.
  • Short Form-36 (SF-36) - Quality of Life Score [ Time Frame: Screening (28 days before study drug administration), Baseline and Week 24 ]
    The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.
  • Change From Baseline in Simpson Angus Rating Scale (SAS) Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms.
  • Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).
  • Number of Participants Compliant With Study Treatment [ Time Frame: 6 months before administration of study drug and 6 months after administration of study drug ]
    Participants compliant with study treatment will be the participants who will complete the study treatment regimen.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2007)
Compare the PSP (Personal and Social Performance) score, CGI (Clinical Global Impression) score and SQLS (Quality of Life) at endpoint versus the baseline and pre-risperidone long acting period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Long-acting Risperidone in Participants With Schizophrenia or Schizoaffective Disorders Who Are Receiving Psychiatric Home Care Treatment
Official Title  ICMJE Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Schizoaffective Disorders, Who is Receiving Psychiatric Home-care Treatment, When Switching From Typical Depot or Oral Antipsychotics to Long-acting Risperidone Microspheres
Brief Summary The purpose of this study is to evaluate the efficacy and safety of long-acting risperidone microspheres (small uniformly-sized spherical particles, of micrometer dimensions, frequently labeled with radioisotopes or various reagents acting as tags or markers) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) and schizoaffective disorders (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder), who are receiving psychiatric home-care treatment .
Detailed Description This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-randomized and single-arm study of long- acting risperidone microspheres in participants with schizophrenia and schizoaffective disorders. The duration of this study will be 6 months and will include following parts: Screening (that is, 28 days before study commences on Day 1), run-in period (that is, Week 1 to 3) and Treatment period (that is, Week 1 to 24). Participants will receive previous medication for the first three weeks during run-in period and previous medications will be tapered off during the third week. Participants will receive long-acting risperidone microspheres starting at a dose of 25 milligram (mg) every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy of the participants will be primarily evaluated through Positive and Negative Syndrome Scale.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorders
Intervention  ICMJE Drug: Risperidone
Risperidone long-acting injectable 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 24 weeks.
Other Name: Risperdal Consta
Study Arms  ICMJE Experimental: Risperidone
Risperidone long-acting injectable 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 24 weeks.
Intervention: Drug: Risperidone
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: December 16, 2013)
31
Original Enrollment  ICMJE
 (submitted: September 6, 2007)
200
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
  • Participant has been given an adequate dose of an appropriate antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsatisfactory due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
  • Female participants must be postmenopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine betahuman chorionic gonadotropin (HCG) pregnancy test at screening; and a negative urine pregnancy test on screening visit
  • Participants or their legally acceptable representatives must have signed an informed consent document

Exclusion Criteria:

  • Participants with a primary, active DSM-IV diagnosis other than schizophrenia and schizoaffective disorder
  • Participants with relevant history or current presence of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic or other systemic disease
  • Participants that are previously on concomitant use of Risperdal CONSTA
  • History or current symptoms of tardive dyskinesia
  • History of neuroleptic malignant syndrome (NMS)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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  
 
Administrative Information
NCT Number  ICMJE NCT00526877
Other Study ID Numbers  ICMJE CR013873
RISSCH4119
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Taiwan Ltd
Study Sponsor  ICMJE Johnson & Johnson Taiwan Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
PRS Account Johnson & Johnson Taiwan Ltd
Verification Date February 2014

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