Clinical Risk State for Bipolar Disorder in Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Northwell Health
Sponsor:
Information provided by (Responsible Party):
Christoph U. Correll, MD, Northwell Health
ClinicalTrials.gov Identifier:
NCT01383915
First received: June 27, 2011
Last updated: August 18, 2016
Last verified: August 2016
  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:


Further study details as provided by Northwell Health:

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 2019
Estimated Primary Completion Date: May 2019 (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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383915

Contacts
Contact: Christoph U Correll, MD 7184704812 ccorrell@lij.edu
Contact: Eva Sheridan, MD 5165077780 evaschenk78@yahoo.com

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
Northwell Health
Investigators
Principal Investigator: Christoph Correll, MD The Zucker Hillside Hospital, Feinstein Institute for Medical Research
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph U. Correll, MD, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT01383915     History of Changes
Other Study ID Numbers: 06-123 
Study First Received: June 27, 2011
Last Updated: August 18, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 30, 2016