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
  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 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 2014
Estimated Primary Completion Date: May 2014 (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
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

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: January 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014