Clinical Risk State for Bipolar Disorder in Adolescents
Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents
1 other identifier
observational
402
1 country
1
Brief Summary
Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors of the disease development. Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of Bipolar Disorder (BPD) or schizophrenia. Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will differentiate between individuals developing BPD and schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 4, 2023
March 1, 2023
14.3 years
June 27, 2011
March 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects with development of a bipolar or schizophrenia disorder
Diagnostic conversion
within 60 months
Secondary Outcomes (1)
Psychopathology
within 60 months
Study Arms (1)
inpatients
Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder
Eligibility Criteria
Inpatients consecutively admitted to the adolescent inpatient unit of the Zucker Hillside Hospital, NY
You may qualify if:
- Age: 12-18 years;
- Sex: male or female;
- Race/ethnicity: no restrictions;
- Definite or suspected chart diagnosis of BP-II, BP-NOS, cyclothymia, MDD, depressive disorder NOS, dysthymia or mood disorder NOS, schizophrenifiorm disorder or psychotic disorder NOS;
- Subject and parent (if subject\<18) willing and able to provide written, informed consent/assent.
You may not qualify if:
- Estimated Premorbid IQ \< 70;
- Meets DSM-IV criteria for BP-I or schizophrenia, pervasive developmental disorder, autism spectrum disorders, current substance dependence;
- History of medical condition known to affect the brain;
- current group home affiliation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
The Zucker Hillside Hospital, NSLIJ
Glen Oaks, New York, 11004, United States
Related Publications (1)
Gerstenberg M, Hauser M, Al-Jadiri A, Sheridan EM, Kishimoto T, Borenstein Y, Vernal DL, David L, Saito E, Landers SE, Carella M, Singh S, Carbon M, Jimenez-Fernandez S, Birnbaum ML, Auther A, Carrion RE, Cornblatt BA, Kane JM, Walitza S, Correll CU. Frequency and correlates of DSM-5 attenuated psychosis syndrome in a sample of adolescent inpatients with nonpsychotic psychiatric disorders. J Clin Psychiatry. 2015 Nov;76(11):e1449-58. doi: 10.4088/JCP.14m09435.
PMID: 26646040DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Correll, MD
The Zucker Hillside Hospital, Feinstein Institute for Medical Research
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 27, 2011
First Posted
June 28, 2011
Study Start
September 1, 2009
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
April 4, 2023
Record last verified: 2023-03