Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001247
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
1999-11-03
Brief Title:
Inpatient Evaluation of Adults With Schizophrenia
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Inpatient Evaluation of Neuropsychiatric Patients
Status:
RECRUITING
Status Verified Date:
2024-06-17
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 understand the biologic basis of schizophrenia and to determine which symptoms are related to the illness itself and which are related to medications used to treat the illness
Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor and whose pathophysiology remains obscure Brain imaging technologies such s positron emission tomography PET functional magnetic resonance imaging fMRI and magnetic resonance imaging MRI offer opportunities to study the pathophysiology of psychotic disorders by evaluating brain function However the use of anti-psychotic drugs may interfere with the results of such studies In this study psychotropic medication will be discontinued in patients for a short period of time to distinguish the effects of the illness on the brain without the interference of the medications effects on the brain Given that there is a risk that the patients symptoms will increase they are asked to stay on an inpatient unit where the NIMH clinical staff is available to help them 24 hours a day
This study will be conducted in three phases In Phase 1 participants will be admitted to the Clinical Center while continuing to take their medication and will undergo diagnostic interviews physical and laboratory assessments physiological monitoring and neuropsychological testing Behavioral ratings will also be performed and blood and urine samples will be collected During Phase 2 participants will continue taking medications in a blinded fashion for 8 to 12 weeks The active medications will be replaced with a placebo an inactive pill part of that time PET fMRI and MRI scans will be used to monitor how the continuation or lack of medication affects the brain Psychological tests will also be given to measure changes in cognition In Phase 3 participants will have the opportunity for clinical stabilization
Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor and whose pathophysiology remains obscure Brain imaging technologies such s positron emission tomography PET functional magnetic resonance imaging fMRI and magnetic resonance imaging MRI offer opportunities to study the pathophysiology of psychotic disorders by evaluating brain function However the use of anti-psychotic drugs may interfere with the results of such studies In this study psychotropic medication will be discontinued in patients for a short period of time to distinguish the effects of the illness on the brain without the interference of the medications effects on the brain Given that there is a risk that the patients symptoms will increase they are asked to stay on an inpatient unit where the NIMH clinical staff is available to help them 24 hours a day
This study will be conducted in three phases In Phase 1 participants will be admitted to the Clinical Center while continuing to take their medication and will undergo diagnostic interviews physical and laboratory assessments physiological monitoring and neuropsychological testing Behavioral ratings will also be performed and blood and urine samples will be collected During Phase 2 participants will continue taking medications in a blinded fashion for 8 to 12 weeks The active medications will be replaced with a placebo an inactive pill part of that time PET fMRI and MRI scans will be used to monitor how the continuation or lack of medication affects the brain Psychological tests will also be given to measure changes in cognition In Phase 3 participants will have the opportunity for clinical stabilization
Detailed Description:
Objectives
Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor and whose pathophysiology remains obscure Neuroimaging technologies such as PET positron emission tomography fMRI functional magnetic resonance imaging DTI diffusion tensor imaging and MRSI magnetic resonance spectroscopic imaging offer opportunities to elucidate the pathophysiology by studying brain function in living research subjects The use of these techniques to study psychotic disorders is severely limited however by a critical methodological confound antipsychotic treatment The purpose of this protocol is to admit research subjects with schizophrenia and other related disorders to the Clinical Center carefully evaluate their neuropsychiatric status and discontinue psychotropic medications for a brief period so research subjects can be studied without the confound of antipsychotic treatment
Study Population
700 participants
The study will include research subjects with schizophrenia
Study Design
There are several phases to this protocol The first phase is the Screening Evaluation and Stabilization Phase and includes gathering historical data structured diagnostic interviews general physical and laboratory assessments basic physiological monitoring neuropsychological testing limited collection of blood and urine samples and serial behavioral ratings In the second phase Coded Medication Phase research subjects will receive blinded compounds that will contain inactive placebo or active antipsychotic administered in a crossover fashion Patients and unit clinical nursing staff evaluating and caring for the patient will be blind to arm status Each arm normally lasts 4 to 6 weeks The total duration of this phase is 8 to 12 weeks During the Coded Medication Phase research subjects are enrolled in a series of neuroimaging and other approved studies designed to elucidate the neurobiology of these disorders These include studies using neuropsychological testing MEG PET fMRI DTI and MRSI The antipsychotic free period is essential to distinguish the effects of illness versus medication
Outcome Measures
Parameters under investigation include traits that are candidate phenotypes for genetic studies and state-dependent aspects of brain function The combined use of many neuroimaging modalities will allow us to look at the functional relationship between a variety of brain abnormalities hypothesized to play a role in schizophrenia These include hippocampal neurochemical abnormalities deficits in prefrontal cortical activation and dysregulation of subcortical dopamine in a single research subject
Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor and whose pathophysiology remains obscure Neuroimaging technologies such as PET positron emission tomography fMRI functional magnetic resonance imaging DTI diffusion tensor imaging and MRSI magnetic resonance spectroscopic imaging offer opportunities to elucidate the pathophysiology by studying brain function in living research subjects The use of these techniques to study psychotic disorders is severely limited however by a critical methodological confound antipsychotic treatment The purpose of this protocol is to admit research subjects with schizophrenia and other related disorders to the Clinical Center carefully evaluate their neuropsychiatric status and discontinue psychotropic medications for a brief period so research subjects can be studied without the confound of antipsychotic treatment
Study Population
700 participants
The study will include research subjects with schizophrenia
Study Design
There are several phases to this protocol The first phase is the Screening Evaluation and Stabilization Phase and includes gathering historical data structured diagnostic interviews general physical and laboratory assessments basic physiological monitoring neuropsychological testing limited collection of blood and urine samples and serial behavioral ratings In the second phase Coded Medication Phase research subjects will receive blinded compounds that will contain inactive placebo or active antipsychotic administered in a crossover fashion Patients and unit clinical nursing staff evaluating and caring for the patient will be blind to arm status Each arm normally lasts 4 to 6 weeks The total duration of this phase is 8 to 12 weeks During the Coded Medication Phase research subjects are enrolled in a series of neuroimaging and other approved studies designed to elucidate the neurobiology of these disorders These include studies using neuropsychological testing MEG PET fMRI DTI and MRSI The antipsychotic free period is essential to distinguish the effects of illness versus medication
Outcome Measures
Parameters under investigation include traits that are candidate phenotypes for genetic studies and state-dependent aspects of brain function The combined use of many neuroimaging modalities will allow us to look at the functional relationship between a variety of brain abnormalities hypothesized to play a role in schizophrenia These include hippocampal neurochemical abnormalities deficits in prefrontal cortical activation and dysregulation of subcortical dopamine in a single research subject
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 89-M-0160 | None | None | None |