An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders

NCT01855074 | Completed Phase 4 Results

• 2 other identifiers: CR014845RISSCH4186
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of long acting injectable microspheres of risperidone in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizophreniform or schizoaffective disorders (disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations).

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder

Keywords

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder; Risperidone; Risperdal consta

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26

  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. Change at Week 26 score is calculated as Baseline score minus Week 26 score.

  Baseline and Week 26

Secondary Outcomes (5)

• Clinical Global Impressions (CGI) - Disease Severity Score

  Baseline and Week 26

• Short Form-36 (SF-36) - Quality of Life Score

  Baseline and Week 26

• Global Assessment of Functioning (GAF) Score

  Baseline and Week 26

• Patient Satisfaction With Treatment

  Baseline and Week 26

• Extrapyramidal Symptom Rating Scale (ESRS) Score

  Baseline and Week 26

Study Arms (1)

Risperidone

EXPERIMENTAL

Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion.

Drug: Risperidone

Interventions

Risperidone DRUG

Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion.

Risperidone

Eligibility Criteria

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

You may qualify if:

• Symptomatically stable participants defined as a) participants with treatment on outpatient and inpatient basis for at least 4 weeks before entering the study, and b) Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score less than or equal to (\<= ) 3 (1-7), including conceptual disorganization, suspicion, hallucinatory conduct and delirium (state of violent mental agitation)
• Participants under antipsychotic treatment with extrapyramidal symptoms, persistent negative symptoms or lack of adherence defined as irregular administration of medication in the last 2 weeks
• Participants who have given their informed consent in writing, or at least, by their family member or personal representative

You may not qualify if:

• Participants taking first antipsychotic treatment in his/her life
• Pregnant or nursing women
• History of neuroleptic malignant syndrome (potentially fatal syndrome associated primarily with the use of antipsychotic drugs and clinical features include diffuse muscle rigidity, tremor, high fever) or current symptoms of tardive dyskinesia (a neurological disorder characterized by involuntary movements of the face and jaw)
• Participants with known intolerance or lack of response to risperidone

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The planned sample size was not reached and a high dropout rate of participants was observed. Due to the high number of protocol violations, analysis was performed as intention-to-treat instead of per protocol as was planned.

Results Point of Contact

• Title: Medical Manager Neurosciences
• Organization: Janssen. Pharmaceutical Companies of Johnson and Johnson

dmuschet@its.jnj.com

+507-3989740

Study Officials

• Janssen-Cilag Ltd. Clinical trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: May 16, 2013
• Study Start: November 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 14, 2013
• Results First Posted: July 25, 2013

Record last verified: 2013-08