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Clinical Risk State for Bipolar Disorder in Adolescents

This study is currently recruiting participants.
Verified April 2013 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: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Bipolar Disorder
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Development of a bipolar or schizophrenia disorder [ Time Frame: within 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: September 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
inpatients

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383915

Contacts
Contact: Christoph U Correll, MD 7184704812 ccorrell@lij.edu

Locations
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     ccorrell@lij.edu    
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Study Director: Christoph Correll, MD The Zucker Hillside Hospital, Feinstein Institute for Medical Research
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01383915     History of Changes
Other Study ID Numbers: 06-123
Study First Received: June 27, 2011
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
 Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 16, 2013