Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder

NCT01888107 | Completed Phase 3

• 2 other identifiers: CR0049932004-000830-35
• Study Type: interventional
• Target: 347
• Locations: 0 countries
• Sites: N/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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Antipsychotics; Risperidone; Long-acting injectable

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score

  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

  Baseline and after 4, 12, 26, 38 and 52 weeks

Secondary Outcomes (5)

• Clinical Global Impression-Severity (CGI-S) scale

  Baseline

• Change from Baseline in Clinical Global Impression-Change (CGI-C) scale

  Baseline and after 4, 12, 26, 38 and 52 weeks

• Change from Baseline in Global Assessment of Functioning (GAF)

  Baseline and after 4, 12, 26, 38 and 52 weeks

• Change from Baseline in Drug Attitude Inventory (DAI 30)

  Baseline and after 4, 12, 26, 38 and 52 weeks

• The number of patients who experience adverse events as a measure of safety and tolerability.

  Baseline and after 4, 12, 26, 38 and 52 weeks

Study Arms (1)

Risperidone Long-acting Injectable (LAI)

EXPERIMENTAL

Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.

Drug: Risperidone Long-acting Injectable (LAI) 25 mg; Drug: Risperidone LAI 37.5 mg; Drug: Risperidone LAI 50 mg

Interventions

Risperidone Long-acting Injectable (LAI) 25 mg DRUG

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

Risperidone Long-acting Injectable (LAI)

Risperidone LAI 37.5 mg DRUG

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

Risperidone Long-acting Injectable (LAI)

Risperidone LAI 50 mg DRUG

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

Risperidone Long-acting Injectable (LAI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag S.p.A.: lead

Related Links

• Maintenance of clinical response with risperidone long-acting injectable (R-LAI) in subjects with schizophrenia or schizoaffective disorder

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Janssen-Cilag S.p.A., Italy Clinical Trial

  Janssen-Cilag S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: January 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: June 27, 2013

Record last verified: 2013-06