A Study of the Relationship of Psychosocial Function With Mood Symptoms in Offspring of Parents With Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT03017781|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : May 7, 2021
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|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||224 participants|
|Official Title:||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|
|Actual Study Start Date :||October 25, 2016|
|Actual Primary Completion Date :||April 30, 2021|
|Actual Study Completion Date :||April 30, 2021|
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
A group of offspring of bipolar parents with no impairment in psychosocial functioning will be used for comparison.
- 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) [ Time Frame: Up to 24 months ]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.
- 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) [ Time Frame: Up to 24 months ]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.
- Global Assessment of Functioning (GAF) [ Time Frame: Up to 24 months ]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.
- Bipolar Prodrome Symptom Interview and Scale-Prospective (BPSS-P) [ Time Frame: Up to 24 months ]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.
- Mini International Neuropsychiatric Interview (MINI) [ Time Frame: Up to 24 months ]MINI is a short, structured diagnostic interview for psychiatric disorders, divided into modules identified by letters, each corresponding to a diagnostic category.
- Neuropsychological Testing [ Time Frame: Up to 24 months ]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.
- General Behavioral Inventory (GBI) [ Time Frame: Up to 24 months ]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).
- Changes in Quality of Life as Assessed Using the Qol (EQ-5D-5L) Scale [ Time Frame: Up to 24 months ]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.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||15 Years to 25 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017781
|United States, California|
|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|
|United States, Florida|
|Tampa, Florida, United States|
|United States, Indiana|
|Indianapolis, Indiana, United States|
|United States, Maryland|
|Baltimore, Maryland, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|United States, Michigan|
|Ann Arbor, Michigan, United States|
|United States, New York|
|Glen Oaks, New York, United States|
|Rochester, New York, United States|
|United States, North Carolina|
|Raleigh, North Carolina, United States|
|United States, Ohio|
|Cincinnati, Ohio, United States|
|Cleveland, Ohio, United States|
|Columbus, Ohio, United States|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States|
|United States, Texas|
|Austin, Texas, United States|
|Dallas, Texas, United States|
|El Paso, Texas, United States|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|
|Responsible Party:||Janssen Research & Development, LLC|
|Other Study ID Numbers:||
NOPRODBIP0001 ( Other Identifier: Janssen Research & Development, LLC )
|First Posted:||January 11, 2017 Key Record Dates|
|Last Update Posted:||May 7, 2021|
|Last Verified:||May 2021|
|Studies a U.S. FDA-regulated Device Product:||No|
Bipolar and Related Disorders