Schizophrenia Clinical Trial
— BICEPSOfficial title:
Brain Imaging, Cognitive Enhancement and Early Schizophrenia
Verified date | February 2021 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed project is designed to examine the effects of cognitive rehabilitation on brain structure and function in a randomized trial of 102 early course schizophrenia patients treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched Supportive Therapy (EST) control, and then followed-up at 1-year post-treatment.
Status | Completed |
Enrollment | 102 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: Patients will be included if they have: 1. a diagnosis of schizophrenia or schizoaffective disorder verified by the SCID (in our data patients with both conditions respond similarly to CET); 2. duration since first psychotic symptom of < 10 years; 3. stable positive symptoms based on medical record review and SCID for at least 2 months; 4. are currently maintained on and compliant with prescribed antipsychotic medication; 5. age 18-55 years; 6. significant social and cognitive disability based on the Cognitive Style and Social Cognition Eligibility Interview utilized in previous CET studies; 7. current IQ >= 80; and 8. the ability to read (sixth grade level or higher) and speak fluent English. This is a study of early course schizophrenia, not first-episode schizophrenia. A duration of illness since first psychotic symptom of < 10 years is adequate to define the early phase of the illness, particularly given that the average duration of untreated psychosis is a year or more. Eligibility criteria regarding IQ are justified from previous experience with CET indicating that individuals with severe mental incapacity are better served with less cognitively advanced programs. Exclusion Criteria: In order to avoid confounders likely to affect cognition and limit response to cognitive rehabilitation, we will exclude those with: 1. significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury); 2. persistent suicidal or homicidal behavior; 3. a recent (within the past 3 months) history of substance abuse or dependence; and 4. any MRI contraindications such as ferromagnetic objects in the body. |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Massachusetts Institute of Technology | Cambridge | Massachusetts |
United States | Massachusetts General Hospital | Charlestown | Massachusetts |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Western Psychiatry Institute and Clinic | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Massachusetts General Hospital, National Institute of Mental Health (NIMH), University of Pittsburgh |
United States,
Eack SM, Hogarty GE, Cho RY, Prasad KM, Greenwald DP, Hogarty SS, Keshavan MS. Neuroprotective effects of cognitive enhancement therapy against gray matter loss in early schizophrenia: results from a 2-year randomized controlled trial. Arch Gen Psychiatry. 2010 Jul;67(7):674-82. doi: 10.1001/archgenpsychiatry.2010.63. Epub 2010 May 3. — View Citation
Insel TR. Translating scientific opportunity into public health impact: a strategic plan for research on mental illness. Arch Gen Psychiatry. 2009 Feb;66(2):128-33. doi: 10.1001/archgenpsychiatry.2008.540. — View Citation
Keshavan MS, Hogarty GE. Brain maturational processes and delayed onset in schizophrenia. Dev Psychopathol. 1999 Summer;11(3):525-43. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Confirm the neuroprotective effects of CET on frontal and temporal brain structure | Aim #1: Confirm the neuroprotective effects of CET on frontal and temporal brain structure. Structural magnetic resonance imaging (MRI) assessments will be collected along with cognitive and functional outcome data at baseline, 9, and 18 months. It is hypothesized that patients treated with CET will demonstrate decreased loss of frontal and temporal gray matter relative to EST, and that this neuroprotection will be a mechanism of cognitive and functional improvement. | 18 months | |
Primary | Examine the effects of CET on fronto-temporal brain function. | Aim #2: Examine the effects of CET on fronto-temporal brain function. Functional MRI data using established executive and social cognition paradigms will be collected at baseline, 9, and 18 months along with cognitive and functional outcome data. It is hypothesized that CET patients will demonstrate enhanced fronto-temporal brain activity during these tasks relative to EST (see Section 3C.6.2 for specific predictions), and that this enhanced brain activity will be a mechanism of cognitive and functional improvement. | 18 Months | |
Primary | Examine the durability of CET effects on fronto-temporal brain structure and function, cognition, and functional outcome at 1 year post-treatment | Aim #3: Examine the durability of CET effects on fronto-temporal brain structure and function, cognition, and functional outcome at 1 year post-treatment. Identical neuroimaging, cognitive, and behavioral data will be collected as those assessed during active treatment. It is hypothesized that the differential neurobiologic benefits of CET relative to EST observed in Aims 1 and 2, and the cognitive and functional benefits of CET observed during active treatment will be sustained 1 year post-treatment. | 1 year post-treatment | |
Secondary | Explore the effects of a fronto-temporal structural and functional reserve on CET treatment response. | Exploratory Aim: Explore the effects of a fronto-temporal structural and functional reserve on CET treatment response. Moderator analyses will examine whether pre-treatment fronto-temporal structural and functional brain reserves (operationalized in Section 3C.8.2) predict larger cognitive and functional gains in CET. Exploratory analyses will also examine the degree to which later (18 mo) treatment improvement is dependent upon early (9 mo) neuroprotection and increased brain function, which may reflect plasticity. | 18 Months |
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