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 : August 25, 2017
Information provided by (Responsible Party):
Christoph U. Correll, MD, Northwell Health

June 27, 2011
June 28, 2011
August 25, 2017
September 2009
May 2019   (Final data collection date for primary outcome measure)
Development of a bipolar or schizophrenia disorder [ Time Frame: within 24 months ]
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Complete list of historical versions of study NCT01383915 on Archive Site
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Clinical Risk State for Bipolar Disorder in Adolescents
Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents

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.

Prospective, naturalistic, cohort study aiming to characterizing the bipolar and psychotic prodrome thoroughly with a variety of clinical and biological measures.
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Inpatients consecutively admitted to the adolescent inpatient unit of the Zucker Hillside Hospital, NY
  • Bipolar Disorder
  • Schizophrenia
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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.
Same as current
May 2019
May 2019   (Final data collection date for primary outcome measure)

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
12 Years to 18 Years   (Child, Adult)
Contact: Christoph U Correll, MD 7184704812
Contact: Eva Sheridan, MD 5165077780
United States
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Christoph U. Correll, MD, Northwell Health
Northwell Health
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Principal Investigator: Christoph Correll, MD The Zucker Hillside Hospital, Feinstein Institute for Medical Research
Northwell Health
August 2017