A Study of the Relationship of Psychosocial Function With Mood Symptoms in Offspring of Parents With Bipolar Disorder
An Observational Longitudinal Study in Offspring of Parents With Bipolar Disorder to Evaluate the Relationship of Impairment in Psychosocial Functioning With the Manifestation of Mood Symptoms Over 24 Months
2 other identifiers
observational
224
1 country
20
Brief Summary
The primary purpose of this study is to compare, over 24 months, the time spent with clinically significant mood symptoms (ie, mania, depression), as measured by the Longitudinal Interval Follow-Up Evaluation (LIFE) and the Psychiatric Status Rating Scale (PSR), in offspring of bipolar parents with and without at least mild impairment in psychosocial functioning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2016
CompletedFirst Submitted
Initial submission to the registry
December 20, 2016
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedApril 27, 2025
April 1, 2025
4.5 years
December 20, 2016
April 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of Weeks Spent With Clinically Significant Mood Symptoms in a 24-Month Longitudinal Study Period, Which will be Derived From the Longitudinal Interval Follow-up Evaluation (LIFE)
The LIFE is a semi-structured interview developed for prospectively following the course of psychiatric disorders; the LIFE collects detailed psychosocial, psychopathologic and treatment information for a 6-month follow-up interval.
Up to 24 months
Proportion of Weeks Spent With Clinically Significant Mood Symptoms in a 24-Month Longitudinal Study Period, Which will be Derived From the Psychiatric Status Rating (PSR)
Weekly symptomatic status, including symptom severity, will be assessed through the Psychiatric Status Ratings (PSRs). Ratings of 1 or 2 on the PSR represent remission or minimal symptoms; ratings of 3 or 4 represent clinically significant subthreshold symptoms; a rating of 5 represents a current episode of hypomania or moderate major depression; and a rating of 6 represents a current episode of mania or severe depression.
Up to 24 months
Secondary Outcomes (6)
Global Assessment of Functioning (GAF)
Up to 24 months
Bipolar Prodrome Symptom Interview and Scale-Prospective (BPSS-P)
Up to 24 months
Mini International Neuropsychiatric Interview (MINI)
Up to 24 months
Neuropsychological Testing
Up to 24 months
General Behavioral Inventory (GBI)
Up to 24 months
- +1 more secondary outcomes
Study Arms (2)
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
Control Group
A group of offspring of bipolar parents with no impairment in psychosocial functioning will be used for comparison.
Eligibility Criteria
Offspring of parents with Bipolar Disprder (BD) will be recruited primarily at selected sites which are already conducting research in prodromal BD and have the necessary setup and resources already in place to conduct such a study.
You may qualify if:
- Participants must have at least one parent who meets the criteria for diagnosis of Bipolar I disorder (BD-I) or Bipolar II disorder (BD-II), as confirmed by the Mini International Neuropsychiatric Interview (MINI) administered to the parent. MINI will be administered to parent if the history of BD is endorsed by Family Index of Risk for Mood (FIRM) or other medical information (psychiatrist, medical records). The MINI can be administered to the parent remotely through the telephone or video call if an in-person interview is not feasible due to logistical reasons. A diagnosis Bipolar Disorder Not Otherwise Specified in the parent would not qualify for eligibility
- 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
You may not qualify if:
- Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV Diagnosis of bipolar I or bipolar II disorder
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Culver City, California, United States
Unknown Facility
Lemon Grove, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Palo Alto, California, United States
Unknown Facility
Panorama City, California, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Glen Oaks, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
El Paso, Texas, United States
Related Publications (1)
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. 2026 Jan 15;393(Pt B):120492. doi: 10.1016/j.jad.2025.120492. Epub 2025 Oct 15.
PMID: 41106637DERIVED
Biospecimen
Blood and Saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2016
First Posted
January 11, 2017
Study Start
October 25, 2016
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
April 27, 2025
Record last verified: 2025-04