Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- Northwell Health
- Enrollment
- 402
- Locations
- 1
- Primary Endpoint
- Number of subjects with development of a bipolar or schizophrenia disorder
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
Prospective, naturalistic, cohort study aiming to characterizing the bipolar and psychotic prodrome thoroughly with a variety of clinical and biological measures.
Investigators
Christoph U. Correll, MD
Principal Investigator
Northwell Health
Eligibility Criteria
Inclusion Criteria
- •Age: 12-18 years;
- •Sex: male or female;
- •Race/ethnicity: no restrictions;
- •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;
- •Subject and parent (if subject\<18) willing and able to provide written, informed consent/assent.
Exclusion Criteria
- •Estimated Premorbid IQ \< 70;
- •Meets DSM-IV criteria for BP-I or schizophrenia, pervasive developmental disorder, autism spectrum disorders, current substance dependence;
- •History of medical condition known to affect the brain;
- •current group home affiliation.
Outcomes
Primary Outcomes
Number of subjects with development of a bipolar or schizophrenia disorder
Time Frame: within 60 months
Diagnostic conversion
Secondary Outcomes
- Psychopathology(within 60 months)