Treatment With Risperidone Long Acting Injectable (RLAI) in an Early Phase of Psychosis
Is Premorbid Functioning a Predictor of Outcome in Patients With Early Onset Psychosis Treated With Risperdal Consta?
1 other identifier
interventional
303
0 countries
N/A
Brief Summary
The purpose of this research study is to see how well patients in an early phase of their illness respond to treatment and whether this depends on how well they functioned socially, academically and vocationally before becoming ill. The study also examines whether patients with more insight into their illness have better outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Mar 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 25, 2006
CompletedFirst Posted
Study publicly available on registry
August 29, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedMay 17, 2011
April 1, 2010
August 25, 2006
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the use of RLAI in patients in the early phases of psychosis and to test the hypothesis that patients with good vs. poor premorbid functioning will have better treatment response over 6 months as assessed with the Premorbid Adjustment Scale.
Secondary Outcomes (1)
The association of insight and outcomes will be examined using SAI-E and insight item (G 12) from PANSS. Effectiveness (CGI-S/C, PANSS, retention rate), functioning (SF-36, rehospitalisation rates) and safety and tolerability will be assessed.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of schizophrenia/schizoaffective disorder for no longer than 2 years
- At least 2 previous psychotic episodes
- At least 6 months of antipsychotic treatment required
- maximum total Positive and Negative Symptom Score (PANSS) score of \< = 80
- Patients may be currently treated with any antipsychotic (with the exception of clozapine and depot neuroleptics) at doses not exceeding the registered highest recommended dose.
You may not qualify if:
- Already on treatment with RLAI
- Patients requiring treatment at entry with mood stabilizers or antidepressants may enter the study only if a stable dose has been received for 3 months prior to study entry
- Previously received treatment with clozapine
- Known non-responders to previous treatment with at least 2 antipsychotics
- Mental retardation
- Patients with conditions and symptoms that are listed in the SmPC under special warnings and special precautions for use
- Acute risk of suicide in the investigator's opinion at study entry or history of suicidal attempt(s) in the last 3 months before the study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V. Clinical Trial
Janssen Pharmaceutica N.V.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2006
First Posted
August 29, 2006
Study Start
March 1, 2006
Study Completion
November 1, 2007
Last Updated
May 17, 2011
Record last verified: 2010-04