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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT03017781
First received: December 20, 2016
Last updated: January 9, 2017
Last verified: January 2017
  Purpose
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 Phase
Bipolar Disorder
Phase 0

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Global Assessment of Functioning (GAF) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 208
Study Start Date: October 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Genders 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). A diagnosis of Other Specified Bipolar and Related Disorder (formerly described as Bipolar Disorder Not Otherwise Specified in the Diagnostic and Statistical Manual of Mental Disorders [DSM] -IV) 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) -5 Diagnosis of bipolar I or bipolar II disorder
  • DSM-5 Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
  • DSM-5 Diagnosis of neurodevelopmental disorders, including autism spectrum 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03017781

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, California
Not yet recruiting
Lemon Grove, California, United States
Not yet recruiting
Los Angeles, California, United States
Not yet recruiting
Stanford, California, United States
United States, Florida
Not yet recruiting
Tampa, Florida, United States
United States, Indiana
Not yet recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Not yet recruiting
Boston, Massachusetts, United States
United States, Michigan
Not yet recruiting
Ann Arbor, Michigan, United States
United States, Missouri
Not yet recruiting
St. Louis, Missouri, United States
United States, New York
Not yet recruiting
Glen Oaks, New York, United States
Recruiting
Rochester, New York, United States
United States, North Carolina
Not yet recruiting
Raleigh, North Carolina, United States
United States, Ohio
Not yet recruiting
Cincinnati, Ohio, United States
Not yet recruiting
Cleveland, Ohio, United States
Not yet recruiting
Columbus, Ohio, United States
United States, Oklahoma
Not yet recruiting
Oklahoma City, Oklahoma, United States
United States, Tennessee
Withdrawn
Memphis, Tennessee, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03017781     History of Changes
Other Study ID Numbers: CR108257  NOPRODBIP0001 
Study First Received: December 20, 2016
Last Updated: January 9, 2017
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Bipolar
High-Risk Off-Spring
Psychosocial Functioning

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on January 14, 2017