Childhood Onset Psychotic DisordersNCT00049738
Screening for Childhood-Onset Psychotic Disorders
An observational study of Childhood Onset Psychotic Disorders and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Childhood Onset Psychotic Disorders, Schizophrenia, Psychosis
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2002to 5 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females between the ages of 5 and 18
- Onset of psychotic symptoms before 13th birthday and a presumptive diagnosis of either schizophrenia, schizoaffective disorder, MDI syndrome, or psychosis NOS
- Pre-psychotic IQ 70 or above.
Who cannot join
- -Major neurological or medical condition (e.g. temporal lobe epilepsy for which patient is on active treatment), or other psychiatric diagnosis that is the main focus of treatment (e.g. serious eating disorder).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Screening, Evaluation, Diagnosis, Treatment Optimization and Follow-up for Childhood Onset Psychotic Disorders
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.
Read the 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 antipsychotic(s), 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 antipsychotic(s); 5) Discharge to the care of his/her 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 (e.g. 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.
- Keywords
- Psychosis, Childhood Onset Schizophrenia, Schizophrenia, Schizoaffective, Psychotic Disorder, Multidimensionally Impaired Syndrome
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Childhood
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate Diagnosis
Measured: On going
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2002 (estimated)
- Study start29 Oct 2002
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Childhood Onset Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Judith L Rapoport, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049738
- Sponsor's protocol ID
- 030035
- Other IDs
- 03-M-0035
- Status last verified
- 5 Oct 2017
- First submitted
- 12 Nov 2002
- Last updated
- 9 Oct 2017
- Results posted
- No
Publications
Cantor S, Evans J, Pearce J, Pezzot-Pearce T. Childhood schizophrenia: present but not accounted for. Am J Psychiatry. 1982 Jun;139(6):758-62. doi: 10.1176/ajp.139.6.758.
PubMed 7081488Green WH, Campbell M, Hardesty AS, Grega DM, Padron-Gayol M, Shell J, Erlenmeyer-Kimling L. A comparison of schizophrenic and autistic children. J Am Acad Child Psychiatry. 1984 Jul;23(4):399-409. doi: 10.1016/s0002-7138(09)60317-4. No abstract available.
PubMed 6747145Beitchman JH. Childhood schizophrenia. A review and comparison with adult-onset schizophrenia. Psychiatr Clin North Am. 1985 Dec;8(4):793-814.
PubMed 3878510Markovic A, Buckley A, Driver DI, Dillard-Broadnax D, Gochman PA, Hoedlmoser K, Rapoport JL, Tarokh L. Sleep spindle activity in childhood onset schizophrenia: Diminished and associated with clinical symptoms. Schizophr Res. 2020 Sep;223:327-336. doi: 10.1016/j.schres.2020.08.022. Epub 2020 Sep 24.
PubMed 32980206Craddock KES, Zhou X, Liu S, Gochman P, Dickinson D, Rapoport JL. Symptom dimensions and subgroups in childhood-onset schizophrenia. Schizophr Res. 2018 Jul;197:71-77. doi: 10.1016/j.schres.2017.10.045. Epub 2017 Nov 13.
PubMed 29146021Kasoff LI, Ahn K, Gochman P, Broadnax DD, Rapoport JL. Strong Treatment Response and High Maintenance Rates of Clozapine in Childhood-Onset Schizophrenia. J Child Adolesc Psychopharmacol. 2016 Jun;26(5):428-35. doi: 10.1089/cap.2015.0103. Epub 2016 Jan 19.
PubMed 26784704Berman RA, Gotts SJ, McAdams HM, Greenstein D, Lalonde F, Clasen L, Watsky RE, Shora L, Ordonez AE, Raznahan A, Martin A, Gogtay N, Rapoport J. Disrupted sensorimotor and social-cognitive networks underlie symptoms in childhood-onset schizophrenia. Brain. 2016 Jan;139(Pt 1):276-91. doi: 10.1093/brain/awv306. Epub 2015 Oct 22.
PubMed 26493637Anvari AA, Friedman LA, Greenstein D, Gochman P, Gogtay N, Rapoport JL. Hippocampal volume change relates to clinical outcome in childhood-onset schizophrenia. Psychol Med. 2015;45(12):2667-74. doi: 10.1017/S0033291715000677. Epub 2015 May 4.
PubMed 25936396
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening, Evaluation, Diagnosis, Treatment Optimization and Follow-up for Childhood Onset Psychotic Disorders
- ClinicalTrials.gov ID
- NCT00049738
- Acronym / sponsor ID
- 030035
- Keywords
- Psychosis, Childhood Onset Schizophrenia, Schizophrenia, Schizoaffective, Psychotic Disorder, Multidimensionally Impaired Syndrome
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 123 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 29 Oct 2002
- Study completion
- 5 Oct 2017
- First posted
- 13 Nov 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 antipsychotic(s), 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 antipsychotic(s); 5) Discharge to the care of his/her 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 (e.g. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females between the ages of 5 and 18
- Onset of psychotic symptoms before 13th birthday and a presumptive diagnosis of either schizophrenia, schizoaffective disorder, MDI syndrome, or psychosis NOS
- Pre-psychotic IQ 70 or above.
Key exclusion criteria (1 listed)
- -Major neurological or medical condition (e.g. temporal lobe epilepsy for which patient is on active treatment), or other psychiatric diagnosis that is the main focus of treatment (e.g. serious eating disorder).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accurate Diagnosis
Time frame: On going
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Background: PubMed 7081488Cantor S, Evans J, Pearce J, Pezzot-Pearce T. Childhood schizophrenia: present but not accounted for. Am J Psychiatry. 1982 Jun;139(6):758-62. doi: 10.1176/ajp.139.6.758.
- Background: PubMed 6747145Green WH, Campbell M, Hardesty AS, Grega DM, Padron-Gayol M, Shell J, Erlenmeyer-Kimling L. A comparison of schizophrenic and autistic children. J Am Acad Child Psychiatry. 1984 Jul;23(4):399-409. doi: 10.1016/s0002-7138(09)60317-4. No abstract available.
- Background: PubMed 3878510Beitchman JH. Childhood schizophrenia. A review and comparison with adult-onset schizophrenia. Psychiatr Clin North Am. 1985 Dec;8(4):793-814.
- Derived from this study: PubMed 32980206Markovic A, Buckley A, Driver DI, Dillard-Broadnax D, Gochman PA, Hoedlmoser K, Rapoport JL, Tarokh L. Sleep spindle activity in childhood onset schizophrenia: Diminished and associated with clinical symptoms. Schizophr Res. 2020 Sep;223:327-336. doi: 10.1016/j.schres.2020.08.022. Epub 2020 Sep 24.
- Derived from this study: PubMed 29146021Craddock KES, Zhou X, Liu S, Gochman P, Dickinson D, Rapoport JL. Symptom dimensions and subgroups in childhood-onset schizophrenia. Schizophr Res. 2018 Jul;197:71-77. doi: 10.1016/j.schres.2017.10.045. Epub 2017 Nov 13.
- Derived from this study: PubMed 26784704Kasoff LI, Ahn K, Gochman P, Broadnax DD, Rapoport JL. Strong Treatment Response and High Maintenance Rates of Clozapine in Childhood-Onset Schizophrenia. J Child Adolesc Psychopharmacol. 2016 Jun;26(5):428-35. doi: 10.1089/cap.2015.0103. Epub 2016 Jan 19.
- Derived from this study: PubMed 26493637Berman RA, Gotts SJ, McAdams HM, Greenstein D, Lalonde F, Clasen L, Watsky RE, Shora L, Ordonez AE, Raznahan A, Martin A, Gogtay N, Rapoport J. Disrupted sensorimotor and social-cognitive networks underlie symptoms in childhood-onset schizophrenia. Brain. 2016 Jan;139(Pt 1):276-91. doi: 10.1093/brain/awv306. Epub 2015 Oct 22.
- Derived from this study: PubMed 25936396Anvari AA, Friedman LA, Greenstein D, Gochman P, Gogtay N, Rapoport JL. Hippocampal volume change relates to clinical outcome in childhood-onset schizophrenia. Psychol Med. 2015;45(12):2667-74. doi: 10.1017/S0033291715000677. Epub 2015 May 4.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith L Rapoport, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Onset Psychotic Disorders and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate Diagnosis (time frame: On going). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00049738, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.