Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130923
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2005-08-15
Brief Title:
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Risperidone Long-Acting for Alcohol and Schizophrenia Treatment R-LAST
Status:
COMPLETED
Status Verified Date:
2019-04
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:
The purpose of this study is to compare the efficacy of oral risperidone Risperdal to risperidone long-acting Consta in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder
Detailed Description:
Comorbid alcoholsubstance use disorder SUD in people with schizophrenia is a major concern both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia the typical antipsychotic agents are of limited value in controlling alcoholsubstance use in these patients Extrapyramidal dysphoric side effects of conventional neuroleptics may actually promote the use of substances in an attempt to counteract these effects In addition medication non-compliance is common among patients with schizophrenia
Novel antipsychotics have altered treatment expectations and outcomes for patients with severe forms of schizophrenia A growing number of studies have assessed the effects of oral risperidone in persons with dual disorders Potential mechanisms of action by which risperidone and other atypical antipsychotics could decrease substance use include being less likely to cause extrapyramidal side effects than typical agents improving negative symptoms and ameliorating a dysfunction of the brain reward system Risperidone long-acting injectable medication addresses issues of noncompliance while avoiding peak blood levels of oral preparations thereby minimizing EPS and improving negative symptoms of schizophrenia Risperidone may also facilitate dopamine neurotransmission in the prefrontal cortex and correct a hypothesized dysfunction of the brain reward system
This study is an open randomized controlled study to compare intramuscular long-acting risperidone to oral risperidone with blinded ratings to determine whether the long-acting form of risperidone has greater efficacy in reducing substance use Patients with schizophrenia or schizoaffective disorder age 18 to 65 who are taking any single oral antipsychotic medication except clozapine or risperidone long-acting may be enrolled
Novel antipsychotics have altered treatment expectations and outcomes for patients with severe forms of schizophrenia A growing number of studies have assessed the effects of oral risperidone in persons with dual disorders Potential mechanisms of action by which risperidone and other atypical antipsychotics could decrease substance use include being less likely to cause extrapyramidal side effects than typical agents improving negative symptoms and ameliorating a dysfunction of the brain reward system Risperidone long-acting injectable medication addresses issues of noncompliance while avoiding peak blood levels of oral preparations thereby minimizing EPS and improving negative symptoms of schizophrenia Risperidone may also facilitate dopamine neurotransmission in the prefrontal cortex and correct a hypothesized dysfunction of the brain reward system
This study is an open randomized controlled study to compare intramuscular long-acting risperidone to oral risperidone with blinded ratings to determine whether the long-acting form of risperidone has greater efficacy in reducing substance use Patients with schizophrenia or schizoaffective disorder age 18 to 65 who are taking any single oral antipsychotic medication except clozapine or risperidone long-acting may be enrolled
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 |
|---|---|---|---|
| RIS-EMR-4032 | None | None | None |