Clinical Risk State for Bipolar Disorder in Adolescents

March 31, 2023 updated by: Christoph U. Correll, MD, Northwell Health

Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

402

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - Glen Oaks, New York, United States, 11004
    - The Zucker Hillside Hospital, NSLIJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients consecutively admitted to the adolescent inpatient unit of the Zucker Hillside Hospital, NY

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
inpatients Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with development of a bipolar or schizophrenia disorder Time Frame: within 60 months	Diagnostic conversion	within 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychopathology Time Frame: within 60 months	Psychopathology	within 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Gerstenberg M, Hauser M, Al-Jadiri A, Sheridan EM, Kishimoto T, Borenstein Y, Vernal DL, David L, Saito E, Landers SE, Carella M, Singh S, Carbon M, Jimenez-Fernandez S, Birnbaum ML, Auther A, Carrion RE, Cornblatt BA, Kane JM, Walitza S, Correll CU. Frequency and correlates of DSM-5 attenuated psychosis syndrome in a sample of adolescent inpatients with nonpsychotic psychiatric disorders. J Clin Psychiatry. 2015 Nov;76(11):e1449-58. doi: 10.4088/JCP.14m09435.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)