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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODBIP0001 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment of Functioning (GAF) | GAF is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate the social, occupational, and psychological functioning of adults. | Up to 24 months |
| Bipolar Prodrome Symptom Interview and Scale-Prospective (BPSS-P) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Culver City | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41106637 | Derived | 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. |
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Blood and Saliva
The BPSS-P assesses the onset and severity of prodromal symptoms and is divided into 3 sections: Mania, Depression, and General Symptom Index. The BPSS-P yields a total score, and separate scores each of the 3 sections. |
| Up to 24 months |
| Mini International Neuropsychiatric Interview (MINI) | MINI is a short, structured diagnostic interview for psychiatric disorders, divided into modules identified by letters, each corresponding to a diagnostic category. | Up to 24 months |
| Neuropsychological Testing | Neuropsychological testing will be performed using a computerized test battery, as well as "paper-based" neuropsychological tasks to have a better understanding of the contribution of cognitive function and potential deficits in domains relevant for Bipolar Disorder (BD) to the clinical symptoms and longitudinal trajectory over 24 months. | Up to 24 months |
| General Behavioral Inventory (GBI) | GBI is a 73-item, self-assessment questionnaire designed to assess symptoms of depression and mania/hypomania (18 or higher for depression or 13 or lower for mania/hypomania). | Up to 24 months |
| Changes in Quality of Life as Assessed Using the Qol (EQ-5D-5L) Scale | EQ-5D-5L is a quality of life (QoL) preference-based measure of health outcome that provides a simple descriptive profile and a single index value for health status. The instrument consists of 5 dimensions of health, each with 5 levels of problems. | Up to 24 months |
| 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 |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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