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Clinical Risk State for Bipolar Disorder in Adolescents

Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01383915
Enrollment
402
Registered
2011-06-28
Start date
2009-09-30
Completion date
2023-12-31
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Schizophrenia

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.

Interventions

None listed

Sponsors

Northwell Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of subjects with development of a bipolar or schizophrenia disorderwithin 60 monthsDiagnostic conversion

Secondary

MeasureTime frameDescription
Psychopathologywithin 60 monthsPsychopathology

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026