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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01383915
Recruitment Status : Active, not recruiting
First Posted : June 28, 2011
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Christoph U. Correll, MD, Northwell Health

Study Description
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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.


Condition or disease
Bipolar Disorder Schizophrenia

Detailed Description:
Prospective, naturalistic, cohort study aiming to characterizing the bipolar and psychotic prodrome thoroughly with a variety of clinical and biological measures.
Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
inpatients
Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with development of a bipolar or schizophrenia disorder [ Time Frame: within 60 months ]
    Diagnostic conversion


Secondary Outcome Measures :
  1. Psychopathology [ Time Frame: within 60 months ]
    Psychopathology


Eligibility Criteria
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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
Study Population
Inpatients consecutively admitted to the adolescent inpatient unit of the Zucker Hillside Hospital, NY
Criteria

Inclusion Criteria:

  1. Age: 12-18 years;
  2. Sex: male or female;
  3. Race/ethnicity: no restrictions;
  4. 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;
  5. Subject and parent (if subject<18) willing and able to provide written, informed consent/assent.

Exclusion Criteria:

  1. Estimated Premorbid IQ < 70;
  2. Meets DSM-IV criteria for BP-I or schizophrenia, pervasive developmental disorder, autism spectrum disorders, current substance dependence;
  3. History of medical condition known to affect the brain;
  4. current group home affiliation.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
The Zucker Hillside Hospital, NSLIJ
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Christoph Correll, MD The Zucker Hillside Hospital, Feinstein Institute for Medical Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders