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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01383915
Recruitment Status : Recruiting
First Posted : June 28, 2011
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
Christoph U. Correll, MD, Northwell Health

Tracking Information
First Submitted Date June 27, 2011
First Posted Date June 28, 2011
Last Update Posted Date February 18, 2021
Study Start Date September 2009
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2021)
Number of subjects with development of a bipolar or schizophrenia disorder [ Time Frame: within 60 months ]
Diagnostic conversion
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: January 24, 2020)
Psychopathology [ Time Frame: within 60 months ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Clinical Risk State for Bipolar Disorder in Adolescents
Official Title Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents
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.

Detailed Description Prospective, naturalistic, cohort study aiming to characterizing the bipolar and psychotic prodrome thoroughly with a variety of clinical and biological measures.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Inpatients consecutively admitted to the adolescent inpatient unit of the Zucker Hillside Hospital, NY
  • Bipolar Disorder
  • Schizophrenia
Intervention Not Provided
Study Groups/Cohorts inpatients
Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder
Publications * 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, Jiménez-Fernández S, Birnbaum ML, Auther A, Carrión 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 16, 2021)
Original Estimated Enrollment
 (submitted: June 27, 2011)
Estimated Study Completion Date June 30, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sexes Eligible for Study: All
Ages 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contact: Christoph U Correll, MD 7184704812
Contact: Daniel Guinart, MD 718-470-4139 ext 4139
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT01383915
Other Study ID Numbers 06-123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christoph U. Correll, MD, Northwell Health
Study Sponsor Northwell Health
Collaborators Not Provided
Principal Investigator: Christoph Correll, MD The Zucker Hillside Hospital, Feinstein Institute for Medical Research
PRS Account Northwell Health
Verification Date February 2021