Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333177
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2006-06-01
Brief Title:
Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Developmental Processes in Schizophrenic Disorders Cognitive Remediation Medication Adherence and Work Outcome in Recent-Onset Schizophrenia
Status:
COMPLETED
Status Verified Date:
2020-03
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 various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia
Detailed Description:
Schizophrenia is a chronic severe and disabling brain disorder People with schizophrenia often experience hallucinations delusions thought disorders and movement disorders These symptoms make it difficult to maintain a job participate in school and keep up self-care Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis Antipsychotic medications such as risperidone and psychosocial treatments such as cognitive enhancement training and health behavior training are common effective treatments for schizophrenia This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia
Participants in this open label study will be randomly assigned to receive one of the following four combinations of an antipsychotic medication and a psychosocial treatment cognitive enhancement training plus oral risperidone cognitive enhancement training plus long-acting injectable risperidone health behavior training plus oral risperidone or health behavior training plus long-acting injectable risperidone Cognitive enhancement training will entail 2 hours per week of computer-assisted training targeted at improving attention memory and problem-solving skills Additionally participants will attend a weekly 1-hour group meeting to learn how to apply these skills to work and school situations Health behavior training will involve 3 hours per week of relaxation training nutrition education and physical exercise to enhance wellness Participants assigned to receive oral risperidone will receive their medication in pill form at the dosage determined to be optimal by the study psychiatrist Participants assigned to receive injectable risperidone will be given one injection every 2 weeks Dosages will start at 25 mg per injection and will be adjusted as needed
Treatment will continue for 1 year following dosage stabilization which typically occurs 2 to 3 months following study entry For the first 6 months participants assigned to receive health behavior training will attend study visits once a week and participants assigned to receive cognitive enhancement training will attend study visits once a week For the final 6 months all participants will attend study visits twice weekly At each visit participants will receive their assigned psychosocial treatment attend group therapy meet with a case manager for counseling and assessment of symptoms work functioning and social functioning and meet with a psychiatrist to monitor medication response Additional cognitive and health behavior measures will be taken every 6 months to assess treatment effectiveness
Participants in this open label study will be randomly assigned to receive one of the following four combinations of an antipsychotic medication and a psychosocial treatment cognitive enhancement training plus oral risperidone cognitive enhancement training plus long-acting injectable risperidone health behavior training plus oral risperidone or health behavior training plus long-acting injectable risperidone Cognitive enhancement training will entail 2 hours per week of computer-assisted training targeted at improving attention memory and problem-solving skills Additionally participants will attend a weekly 1-hour group meeting to learn how to apply these skills to work and school situations Health behavior training will involve 3 hours per week of relaxation training nutrition education and physical exercise to enhance wellness Participants assigned to receive oral risperidone will receive their medication in pill form at the dosage determined to be optimal by the study psychiatrist Participants assigned to receive injectable risperidone will be given one injection every 2 weeks Dosages will start at 25 mg per injection and will be adjusted as needed
Treatment will continue for 1 year following dosage stabilization which typically occurs 2 to 3 months following study entry For the first 6 months participants assigned to receive health behavior training will attend study visits once a week and participants assigned to receive cognitive enhancement training will attend study visits once a week For the final 6 months all participants will attend study visits twice weekly At each visit participants will receive their assigned psychosocial treatment attend group therapy meet with a case manager for counseling and assessment of symptoms work functioning and social functioning and meet with a psychiatrist to monitor medication response Additional cognitive and health behavior measures will be taken every 6 months to assess treatment effectiveness
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 |
|---|---|---|---|
| DAHBR AD-P | REGISTRY | WHO ICTRP | httpsreporternihgovquickSearchR01MH037705 |
| R01MH037705 | NIH | None | None |