Clinical Risk State for Bipolar Disorder in Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01383915|
Recruitment Status : Recruiting
First Posted : June 28, 2011
Last Update Posted : February 18, 2021
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|
|Bipolar Disorder Schizophrenia|
|Study Type :||Observational|
|Estimated Enrollment :||402 participants|
|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|
Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder
- 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
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
|Contact: Christoph U Correll, MDfirstname.lastname@example.org|
|Contact: Daniel Guinart, MD||718-470-4139 ext 4139||DGuinart@northwell.edu|
|United States, New York|
|The Zucker Hillside Hospital, NSLIJ||Recruiting|
|Glen Oaks, New York, United States, 11004|
|Contact: Christoph U Correll, MD 718-470-4812 email@example.com|
|Principal Investigator:||Christoph Correll, MD||The Zucker Hillside Hospital, Feinstein Institute for Medical Research|