Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective 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: NCT01888107
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag S.p.A.

Brief Summary:
The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy. The secondary aim is to investigate prospectively (a study that starts with the present condition of a population of individuals and follows them into the future) the prevalence of patients who met standardized remission criteria (according to Andreasen et al. criteria) and the psychopathological, psychosocial and subjective predictors of achieving remission.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Risperidone Long-acting Injectable (LAI) 25 mg Drug: Risperidone LAI 37.5 mg Drug: Risperidone LAI 50 mg Phase 3

Detailed Description:
This is a prospective, open-label, (all people know the identity of the intervention), single-arm study conducted at 47 sites in Italy between January 2005 and April 2007. Approximately 338 patients with schizophrenia or schizoaffective disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy will be switched directly to RLAI without an oral risperidone run-in (the elapsed time before a trial is started when no treatment is given to patients in the study). They will be considered either not optimally treated or symptom-free. Patients will be either not hospitalized or living in residential structures at the time of the enrollment as well as throughout the study. The maximum duration of study participation will be 52 weeks. Patient safety will be monitored throughout the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance of Clinical Response With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
Study Start Date : January 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: Risperidone Long-acting Injectable (LAI)
Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.
Drug: Risperidone Long-acting Injectable (LAI) 25 mg
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Drug: Risperidone LAI 37.5 mg
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Drug: Risperidone LAI 50 mg
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.




Primary Outcome Measures :
  1. Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]
    Maintenance= Symptom severity assessed with PANSS scale vs baseline (Total, positive, negative, general psychopathology and cognitive cluster score); Remission= percentage of patients with 8 specific items PANSS simultaneously scoring <= 3 for at least 6 months


Secondary Outcome Measures :
  1. Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: Baseline ]
    This measure is used to evaluate disease severity at baseline (Visit 1).

  2. Change from Baseline in Clinical Global Impression-Change (CGI-C) scale [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]
    This measure is used to evaluate disease severity at the other time points (Visits 2 to 6).

  3. Change from Baseline in Global Assessment of Functioning (GAF) [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]
    GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. Lower scores indicate worsening.

  4. Change from Baseline in Drug Attitude Inventory (DAI 30) [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]
    Personal attitude towards risperidone long-acting injectable treatment is rated by a subjective questionnaire that is administered at each study visit (1 through 6).

  5. The number of patients who experience adverse events as a measure of safety and tolerability. [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
  • Required long-term antipsychotic therapy at the time of recruitment
  • Symptomatically stable and taking the same dose of antipsychotic agents for at least one month before the baseline visit (considered stable if there have been no appreciable change in symptoms over the previous month, regardless of the severity of their symptoms)
  • Patients or their legal representatives provided their written informed consent prior to enrollment in the study

Exclusion Criteria:

  • Patients who had received clozapine during the previous 3 months
  • Participated in an investigational drug trial in the previous 30 days
  • Previously been shown to be either intolerant or non-responsive to risperidone therapy
  • Presence of a serious unstable medical condition, such as a history or current symptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome
  • Pregnant or breast-feeding; female patients of childbearing potential not using adequate contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888107


Sponsors and Collaborators
Janssen-Cilag S.p.A.
Investigators
Layout table for investigator information
Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial Janssen-Cilag S.p.A.
Additional Information:
Layout table for additonal information
Responsible Party: Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier: NCT01888107    
Other Study ID Numbers: CR004993
2004-000830-35 ( EudraCT Number )
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013
Keywords provided by Janssen-Cilag S.p.A.:
Schizophrenia
Schizoaffective Disorder
Antipsychotics
Risperidone
Long-acting injectable
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents