A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis

NCT00246259 | Completed Phase 4 Results

• 2 other identifiers: CR005959RISSCH4056
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations).

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorders

Keywords

Schizophrenia; Schizoaffective disorder; Schizophreniform disorder; Risperidone; Risperdal Consta

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)

  The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

  Baseline, Week 104 or LRV

• Time to Relapse

  Time to relapse was calculated from the start of the maintenance phase to date of relapse according to Csernansky: "Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as Clinical Global Impression of Change (CGI-C) score of 6 (much worse)".

  Week 10 (post-stability) up to Week 104 or LRV

• Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV

  The SOFAS focused exclusively on participants' level of social and occupational functioning. The SOFAS is a 100 point single item scale that rates functioning of a participant. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.

  Baseline, Week 104 or LRV

Secondary Outcomes (9)

• Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV

  Baseline, Week 104 or LRV

• Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV

  Baseline, Week 104 or LRV

• Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV

  Baseline, Week 104 or LRV

• Percentage of Participants With Relapse

  Week 10 (post-stability) up to Week 104 or LRV

• Number of Participants With Cognitive Assessment Using Trail A

  Week -2, 104 or LRV

Other Outcomes (3)

• Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment

  Baseline, Week 104 or LRV

• Simpson Angus Scale (SAS)

  Baseline, Week 104 or LRV

• Abnormal Involuntary Movement Scale (AIMS)

  Baseline, Week 104 or LRV

Study Arms (2)

Risperidone long-acting injection (LAI)

EXPERIMENTAL

Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.

Drug: Risperidone long-acting injection (LAI)

Oral Antipsychotic

ACTIVE COMPARATOR

Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants will be switched to another oral therapy as per Investigator's discretion.

Drug: Oral Antipsychotic

Interventions

Risperidone long-acting injection (LAI) DRUG

Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion.

Risperidone long-acting injection (LAI)

Oral Antipsychotic DRUG

Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.

Oral Antipsychotic

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In-patients or out-patients
• Primary Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder for no longer than 3 years after diagnosis and treatment of a psychotic illness
• Positive and Negative Syndrome Scale (PANSS) score of 60-120 at Visit 1 and 2
• Currently on monotherapy atypical antipsychotic treatment below local label guidelines or treatment naive
• Able to complete self-assessments in either English or French

You may not qualify if:

• Current primary Axis-1 diagnosis other than schizophrenia, schizophreniform disorder or schizoaffective disorder, according to DSM-IV
• Current drug or alcohol dependence
• Treatment with a depot antipsychotic within 3 months of study start
• Confirmed or suspected history of lack of tolerability, hypersensitivity or allergy to risperidone
• Risperidone non-responders (based on evidence of adequate trial of treatment)

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

Study Sites (11)

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Unknown Facility

Dartmouth, Nova Scotia, Canada

Location

Unknown Facility

Greater Sudbury, Ontario, Canada

Location

Unknown Facility

Kingston, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Markham, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Québec, Quebec, Canada

Location

Unknown Facility

Verdun, Quebec, Canada

Location

Related Links

• An Open-label Randomized Trial Comparing RISPERDAL\*CONSTA\* With Oral Antipsychotic Care in the Treatment of Early Psychosis

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Results Point of Contact

• Title: Director Medical Affairs - CNS
• Organization: Janssen Inc., Toronto, ON, Canada

+1-416-382-5094

Study Officials

• Janssen Inc. Clinical Trial

  Janssen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: October 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 11, 2013
• Results First Posted: November 12, 2013

Record last verified: 2013-11

Locations

CA (11)