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An Open-Label Randomized Trial Comparing Risperdal Consta With Oral Antipsychotic Care in the Treatment of Early Psychosis
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).
Details
| Lead sponsor | Janssen-Ortho Inc., Canada |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 77 |
| Start date | 2004-10 |
| Completion | 2008-12 |
Conditions
- Schizophrenia
- Schizoaffective Disorder
- Schizophreniform Disorder
- Psychotic Disorders
Interventions
- Risperidone long-acting injection (LAI)
- Oral Antipsychotic
Primary outcomes
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV) — Baseline, Week 104 or 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. - Time to Relapse — Week 10 (post-stability) up to Week 104 or LRV
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)". - Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV — Baseline, 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.
Countries
Canada