NCT00049738

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2002

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2002

Completed
14.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 5, 2017

First QC Date

November 12, 2002

Last Update Submit

October 6, 2017

Conditions

Keywords

PsychosisChildhood Onset SchizophreniaSchizophreniaSchizoaffectivePsychotic DisorderMultidimensionally Impaired Syndrome

Outcome Measures

Primary Outcomes (1)

  • Accurate Diagnosis

    On going

Eligibility Criteria

Age5 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (8)

  • 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.

    PMID: 7081488BACKGROUND
  • Green 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.

    PMID: 6747145BACKGROUND
  • Beitchman JH. Childhood schizophrenia. A review and comparison with adult-onset schizophrenia. Psychiatr Clin North Am. 1985 Dec;8(4):793-814.

    PMID: 3878510BACKGROUND
  • Markovic 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.

  • Craddock 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.

  • Kasoff 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.

  • Berman 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.

  • Anvari 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.

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSchizophrenia, Childhood

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurodevelopmental Disorders

Study Officials

  • Judith L Rapoport, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2002

First Posted

November 13, 2002

Study Start

October 29, 2002

Study Completion

October 5, 2017

Last Updated

October 9, 2017

Record last verified: 2017-10-05

Locations