Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167362
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2005-09-09
Brief Title:
Cognitive Enhancement Therapy for Early-Stage Schizophrenia
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Rehabilitation Brain Function and Early Schizophrenia
Status:
COMPLETED
Status Verified Date:
2017-01
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 cognitive enhancement therapy CET in treating cognitive abnormalities in people experiencing the early stages of schizophrenia
Detailed Description:
In this study we wish to determine the neurobiological predictors and the relative efficacy of Cognitive Enhancement Therapy CET in ameliorating specific cognitive abnormalities presumably mediated by PFC and related brain structures among younger early-course schizophrenia patients who potentially have a better prognosis A series of recent-onset schizophrenic patients whose psychotic symptoms have successfully been stabilized on an atypical antipsychotic drug for one year following initiation of treatment will be randomized to CET combined with an enriched supportive therapy EST or EST alone and treated for two years Subjects will have been assessed on neurobehavioral and clinical indices immediately prior to beginning CET or EST corresponding with the CNMD 1-year follow-up and in the proposed study will again be assessed after 1 and 2 years of psychosocial treatment In a smaller subset of patients we will also seek to collect preliminary data on the efficacy of CET in reversing the neurobiological alterations in the PFC The hypotheses of this study are
1 The presence of relatively well preserved PFC structure and function PFC volume activation with fMRI and metabolism as measured by proton MRS at baseline will predict a better response to CET Neurobiological Prediction Hypothesis
2 CET combined with enriched supportive psychotherapy EST will be more effective than EST alone in ameliorating social and non-social cognitive deficits of patients with early schizophrenic illness whose psychotic symptoms have been stabilized on maintenance chemotherapy The Treatment Efficacy Hypothesis
3 CET will result in additive positive effects on neurocognitive parameters that were not observed following one year of antipsychotic medication using a sequential treatment design in a subset of patients in whom we have pre-neuroleptic baseline data from CNMD studies The Treatment Specificity Hypothesis
Study Design Subjects will be randomly assigned once stabilized clinically to CET plus EST n 30 or EST alone n 30 and then treated for up to two years Clinical neuropsychological neurological and functional neuroimaging assessments will be administered at baseline and at two annual follow-ups At the end of CET or EST treatment subjects will be asked to come back quarterly to meet informally with either their Cognitive Enhancement Therapy clinicians and former group members or with their Enriched Supportive Therapy clinician The purpose of these visits is for us to learn more about the successes that patients have had or about the difficulties that they might have had since leaving the program Clinicians will also share information obtained during this follow-up which might help patient in overcoming these difficulties At the end of the one-year period post EST or CET treatment subjects will be assessed on all measures except for diagnostic imaging and blood studies
1 The presence of relatively well preserved PFC structure and function PFC volume activation with fMRI and metabolism as measured by proton MRS at baseline will predict a better response to CET Neurobiological Prediction Hypothesis
2 CET combined with enriched supportive psychotherapy EST will be more effective than EST alone in ameliorating social and non-social cognitive deficits of patients with early schizophrenic illness whose psychotic symptoms have been stabilized on maintenance chemotherapy The Treatment Efficacy Hypothesis
3 CET will result in additive positive effects on neurocognitive parameters that were not observed following one year of antipsychotic medication using a sequential treatment design in a subset of patients in whom we have pre-neuroleptic baseline data from CNMD studies The Treatment Specificity Hypothesis
Study Design Subjects will be randomly assigned once stabilized clinically to CET plus EST n 30 or EST alone n 30 and then treated for up to two years Clinical neuropsychological neurological and functional neuroimaging assessments will be administered at baseline and at two annual follow-ups At the end of CET or EST treatment subjects will be asked to come back quarterly to meet informally with either their Cognitive Enhancement Therapy clinicians and former group members or with their Enriched Supportive Therapy clinician The purpose of these visits is for us to learn more about the successes that patients have had or about the difficulties that they might have had since leaving the program Clinicians will also share information obtained during this follow-up which might help patient in overcoming these difficulties At the end of the one-year period post EST or CET treatment subjects will be assessed on all measures except for diagnostic imaging and blood studies
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 |
|---|---|---|---|
| DATR A2-AISZ | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH060902 |
| R01MH060902 | NIH | None | None |