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A Study of the Relationship of Psychosocial Function With Mood Symptoms in Offspring of Parents With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017781
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

Condition or disease
Bipolar Disorder

Study Design
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Study Type : Observational
Actual Enrollment : 224 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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
Blood and Saliva

Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03017781    
Other Study ID Numbers: CR108257
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

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Bipolar
High-Risk Off-Spring
Psychosocial Functioning
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mood Disorders
Mental Disorders