Clinical Risk State for Bipolar Disorder in Adolescents

Schizophrenia Clinical Trial

Official title:

Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01383915
• Other study ID #: 06-123
• Status: Active, not recruiting
• Start date: September 2009
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 402
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Locations

Country	Name	City	State
United States	The Zucker Hillside Hospital, NSLIJ	Glen Oaks	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with development of a bipolar or schizophrenia disorder	Diagnostic conversion	within 60 months
Secondary	Psychopathology	Psychopathology	within 60 months