Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330551
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2006-05-26
Brief Title:
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-episode Schizophrenia
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia
Detailed Description:
Schizophrenia is a severely disabling brain disorder People with schizophrenia often experience hallucinations delusions thought disorders and movement disorders Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia but are also more susceptible to adverse treatment side effects Atypical antipsychotic medications have been shown to produce fewer adverse side effects than older typical antipsychotics Risperidone is a type of atypical antipsychotic medication that is used to control the symptoms of schizophrenia This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia
Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting risperidone administered via injection Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist Participants assigned to long-acting risperidone will receive an injection of risperidone once every 2 weeks Dosages will begin at 25 mg and will be adjusted as necessary to achieve the optimal dosage Following 2 to 3 months to achieve outpatient risperidone dosage stabilization the randomized medication conditions will begin and participants will be monitored for 1 year Study visits will occur once weekly throughout the study They will include group therapy meetings focused on everyday living skills family education about schizophrenia assessments of medication response and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms
Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting risperidone administered via injection Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist Participants assigned to long-acting risperidone will receive an injection of risperidone once every 2 weeks Dosages will begin at 25 mg and will be adjusted as necessary to achieve the optimal dosage Following 2 to 3 months to achieve outpatient risperidone dosage stabilization the randomized medication conditions will begin and participants will be monitored for 1 year Study visits will occur once weekly throughout the study They will include group therapy meetings focused on everyday living skills family education about schizophrenia assessments of medication response and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Janssen RIS-NAP-4009 | OTHER_GRANT | Janssen Scientific Affairs | httpsreporternihgovquickSearchP50MH066286 |
| P50MH066286 | NIH | None | None |
| DATR A2-AISZ | REGISTRY | None | None |