Clinical Risk State for Bipolar Disorder in Adolescents
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ClinicalTrials.gov Identifier: NCT01383915 |
Recruitment Status :
Active, not recruiting
First Posted : June 28, 2011
Last Update Posted : April 6, 2022
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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.
Condition or disease |
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Bipolar Disorder Schizophrenia |
Study Type : | Observational |
Estimated Enrollment : | 402 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents |
Study Start Date : | September 2009 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | June 30, 2023 |

Group/Cohort |
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inpatients
Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder
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- Number of subjects with development of a bipolar or schizophrenia disorder [ Time Frame: within 60 months ]Diagnostic conversion
- Psychopathology [ Time Frame: within 60 months ]Psychopathology

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Ages Eligible for Study: | 12 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383915
United States, New York | |
The Zucker Hillside Hospital, NSLIJ | |
Glen Oaks, New York, United States, 11004 |
Principal Investigator: | Christoph Correll, MD | The Zucker Hillside Hospital, Feinstein Institute for Medical Research |
Responsible Party: | Christoph U. Correll, MD, Principal Investigator, Northwell Health |
ClinicalTrials.gov Identifier: | NCT01383915 |
Other Study ID Numbers: |
06-123 |
First Posted: | June 28, 2011 Key Record Dates |
Last Update Posted: | April 6, 2022 |
Last Verified: | April 2022 |
Schizophrenia Bipolar Disorder Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Bipolar and Related Disorders |