Clinical Risk State for Bipolar Disorder in Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01383915
First received: June 27, 2011
Last updated: January 21, 2014
Last verified: January 2014

June 27, 2011
January 21, 2014
September 2009
May 2014   (final data collection date for primary outcome measure)
Development of a bipolar or schizophrenia disorder [ Time Frame: within 24 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01383915 on ClinicalTrials.gov 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
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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inpatients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
May 2014
May 2014   (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.
Both
12 Years to 18 Years
Yes
Contact: Christoph U Correll, MD 7184704812 ccorrell@lij.edu
United States
 
NCT01383915
06-123
No
North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
Not Provided
Study Director: Christoph Correll, MD The Zucker Hillside Hospital, Feinstein Institute for Medical Research
North Shore Long Island Jewish Health System
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP