Clinical Risk State for Bipolar Disorder in Adolescents

Active, not recruiting

• Conditions: Bipolar Disorder; Schizophrenia

• Registration Number: NCT01383915
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 402

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects with development of a bipolar or schizophrenia disorder	within 60 months	Diagnostic conversion

Secondary Outcome Measures

Name	Time	Method
Psychopathology	within 60 months	Psychopathology

Trial Locations

Locations (1)

The Zucker Hillside Hospital, NSLIJ; 🇺🇸 Glen Oaks, New York, United States