Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049738
Status:
TERMINATED
Last Update Posted:
2017-10-09
First Post:
2002-11-12
Brief Title:
Screening for Childhood-Onset Psychotic Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening Evaluation Diagnosis Treatment Optimization and Follow-up for Childhood Onset Psychotic Disorders
Status:
TERMINATED
Status Verified Date:
2017-10-05
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 screen and evaluate children with psychotic disorders to establish or confirm their diagnosis and to collect data about their condition This study will also recruit individuals for various treatment studies
Childhood psychotic disorders are debilitating conditions in which children have auditory or visual hallucinations and disorganized thoughts This study will examine psychotic disorders in children in an inpatient setting
Participants in this study will be admitted to the NIH Clinical Center for up to 9 weeks under one or more of the following conditions current medication no medication or tapered medication Participants will undergo blood urine metabolic and intellectual functioning tests An electrocardiogram EKG and electroencephalogram EEG will be performed A magnetic resonance imaging MRI scan of the brain will be taken and infrared oculography will be used to measure eye movements Participants and their family members may also be asked to participate in a study of genetics in children with psychotic illnesses Children meeting criteria for childhood onset schizophrenia may be offered participation in a medication comparison protocol
Childhood psychotic disorders are debilitating conditions in which children have auditory or visual hallucinations and disorganized thoughts This study will examine psychotic disorders in children in an inpatient setting
Participants in this study will be admitted to the NIH Clinical Center for up to 9 weeks under one or more of the following conditions current medication no medication or tapered medication Participants will undergo blood urine metabolic and intellectual functioning tests An electrocardiogram EKG and electroencephalogram EEG will be performed A magnetic resonance imaging MRI scan of the brain will be taken and infrared oculography will be used to measure eye movements Participants and their family members may also be asked to participate in a study of genetics in children with psychotic illnesses Children meeting criteria for childhood onset schizophrenia may be offered participation in a medication comparison protocol
Detailed Description:
Up to 250 children and adolescents ages 5 to 18 meeting DSM IV criteria for schizophrenia schizoaffective disorder and psychotic disorder not otherwise specified are currently under study in our group The purpose of this protocol is to allow systematic outpatient and subsequent inpatient screening evaluation to establish an accurate diagnosis for research obtain clinical and neurobiological research measurements evaluate the patient s response to open treatment with antipsychotics and allow longitudinal follow-up Subjects and first-degree relatives may then be enrolled in Protocol 89-M-0006 Brain Imaging of Childhood Onset Psychiatric Disorders Endocrine Disorders and Healthy Controls and Protocol 84-M-0050 Biochemical Physiological and Psychological Measures in Normal Controls and Relatives of Psychiatric Patients If additional research protocols are available this screening protocol will represent an entry point for them
The evaluation process will include a one-day outpatient psychiatric screening interview with proband and family If it is thought that the child is likely to meet criteria for childhood onset psychoses an inpatient evaluation will then be offered for clarifying the diagnosis This may involve 1 Up to 3 weeks of inpatient observation on the child s current medication regimen 2 Tapering of psychotropic medications 1-4 weeks depending upon type and dosage 3 Observation for up to 3 weeks drug free in order to confirm the diagnosis and 4 Once the diagnosis is confirmed two to ten weeks of treatment with antipsychotics 5 Discharge to the care of hisher community psychiatrist Treatment will be guided by what is considered the subject s best clinical interest During the inpatient stay or occasionally as part of the outpatient screening we will obtain neurocognitive testing research blood draws including blood for genetic testing of the proband and a research brain MRI scan A skin biopsy may be obtained either during the inpatient stay or a follow up visit
This protocol also includes a study 100 non-schizophrenic children ages 6-13 with psychotic symptoms eg hallucinations or delusions to extend our studies of early neuro-developmental biomarkers and of the factors that either promote or stop the progression to full schizophrenia resilience or conversion factors These children will be recruited from the local community evaluated as outpatients and followed prospectively for five years Measures will include diagnostic interviews clinical ratings neurocognitive testing anatomic and functional imaging and blood for routine and genetic testing
The evaluation process will include a one-day outpatient psychiatric screening interview with proband and family If it is thought that the child is likely to meet criteria for childhood onset psychoses an inpatient evaluation will then be offered for clarifying the diagnosis This may involve 1 Up to 3 weeks of inpatient observation on the child s current medication regimen 2 Tapering of psychotropic medications 1-4 weeks depending upon type and dosage 3 Observation for up to 3 weeks drug free in order to confirm the diagnosis and 4 Once the diagnosis is confirmed two to ten weeks of treatment with antipsychotics 5 Discharge to the care of hisher community psychiatrist Treatment will be guided by what is considered the subject s best clinical interest During the inpatient stay or occasionally as part of the outpatient screening we will obtain neurocognitive testing research blood draws including blood for genetic testing of the proband and a research brain MRI scan A skin biopsy may be obtained either during the inpatient stay or a follow up visit
This protocol also includes a study 100 non-schizophrenic children ages 6-13 with psychotic symptoms eg hallucinations or delusions to extend our studies of early neuro-developmental biomarkers and of the factors that either promote or stop the progression to full schizophrenia resilience or conversion factors These children will be recruited from the local community evaluated as outpatients and followed prospectively for five years Measures will include diagnostic interviews clinical ratings neurocognitive testing anatomic and functional imaging and blood for routine and genetic testing
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 |
|---|---|---|---|
| 03-M-0035 | None | None | None |