A Study of the Relationship of Psychosocial Function With Mood Symptoms in Offspring of Parents With Bipolar Disorder
NCT ID: NCT03017781
Last Updated: 2025-04-27
Study Results
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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COMPLETED
224 participants
OBSERVATIONAL
2016-10-25
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Study Group
Offspring (15-25 years old) of parents with Bipolar Disorder (BD) with at least mild impairment in psychosocial functioning were observed to evaluate the relationship of impairment in psychosocial functioning with the manifestation of mood symptoms over 24 months
No interventions assigned to this group
Control Group
A group of offspring of bipolar parents with no impairment in psychosocial functioning will be used for comparison.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participants must be either drug-naive, or on stable treatment for at least 4 weeks.
* Participants (and/or their parents as applicable) must sign an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements and/or sponsor policy. Adolescents (minors) who in the judgment of the investigator are capable of understanding the nature of the study can be enrolled only after obtaining consent of a legally acceptable representative. Assent must be obtained from any participating adolescents (minors), if applicable
* Participants must be willing and able to complete self-reported assessments via mobile electronic device, and to wear a wrist actigraphy device for the duration of the study
Exclusion Criteria
* DSM-IV Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
* DSM-IV Diagnosis of neurodevelopmental disorders
* An intelligence quotient (IQ) score less than (\<) 80 as determined by Kaufman Brief Intelligence Test (K-BIT)
* Uncorrected hypothyroidism or hyperthyroidism
15 Years
25 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Culver City, California, United States
Lemon Grove, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Panorama City, California, United States
Tampa, Florida, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Glen Oaks, New York, United States
Rochester, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Austin, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Countries
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References
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Pandina G, DelBello MP, Rassnick S, Solanki B, Canuso CM, Fristad MA, Correll CU, Nurnberger JI Jr, Singh MK, McInnis MG, Atkinson S, Stedman M, Goes FS, Strakowski SM, Greer TL, Nierenberg AA, Salvadore G, Drevets WC. Clinical outcomes of youth at familial risk for bipolar disorder: A 2-year longitudinal, observational study. J Affect Disord. 2025 Oct 15:120492. doi: 10.1016/j.jad.2025.120492. Online ahead of print.
Other Identifiers
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NOPRODBIP0001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108257
Identifier Type: -
Identifier Source: org_study_id
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