Clinical Risk State for Bipolar Disorder in Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

402 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Bipolar Disorder Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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inpatients

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes