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Clinical Risk State for Bipolar Disorder in Adolescents

Sponsor
Northwell Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01383915
Collaborator
(none)
402
Enrollment
1
Location
165.9
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    402 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents
    Study Start Date :
    Sep 1, 2009
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    inpatients

    Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects with development of a bipolar or schizophrenia disorder [within 60 months]

      Diagnostic conversion

    Secondary Outcome Measures

    1. Psychopathology [within 60 months]

      Psychopathology

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 The Zucker Hillside Hospital, NSLIJ Glen Oaks New York United States 11004

    Sponsors and Collaborators

    • Northwell Health

    Investigators

    • Principal Investigator: Christoph Correll, MD, The Zucker Hillside Hospital, Feinstein Institute for Medical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christoph U. Correll, MD, Principal Investigator, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT01383915
    Other Study ID Numbers:
    • 06-123
    First Posted:
    Jun 28, 2011
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:
    Schizophrenia
    Bipolar Disorder

    Study Results

    No Results Posted as of Apr 6, 2022