Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056498
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2003-03-14
Brief Title:
Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Clozapine Treatment of Schizophrenic Patients
Status:
COMPLETED
Status Verified Date:
2019-09
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 whether adding the drug risperidone Risperdal is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine
Detailed Description:
Clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia However up to 50 of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments An emerging trend in treatment is the addition of a second antipsychotic drug This study will determine if risperidone when given as adjunctive treatment is more effective than placebo in treating schizophrenic patients failing clozapine therapy
Participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single daily dose for 16 weeks Positive and negative symptoms cognitive impairments side effects of the treatment anxiety depression hostility symptoms and quality of life are assessed Neurological tests self administered questionnaires and interviews are used to assess patients
Participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single daily dose for 16 weeks Positive and negative symptoms cognitive impairments side effects of the treatment anxiety depression hostility symptoms and quality of life are assessed Neurological tests self administered questionnaires and interviews are used to assess patients
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 |
|---|---|---|---|
| DSIR 83-ATAP | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH045074 |
| R01MH045074 | NIH | None | None |