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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03017781
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : October 18, 2019
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

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Study Type : Observational
Estimated Enrollment : 208 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
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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.

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

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.

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

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 identifier (NCT number): NCT03017781

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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:

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United States, California
Proscience Research Group Recruiting
Culver City, California, United States, 90230
Synergy East Completed
Lemon Grove, California, United States, 92025-4405
UCLA Semel Institute Completed
Los Angeles, California, United States, 90095
Asclepes Research Recruiting
Panorama City, California, United States, 91402
Stanford Department of Psychiatry and Behavioral Sciences Recruiting
Stanford, California, United States, 64305
United States, Florida
Stedman Medical Trials Recruiting
Tampa, Florida, United States, 33613
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-2700
United States, Missouri
Washington University Withdrawn
Saint Louis, Missouri, United States, 63108
United States, New York
The Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11004
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618-1609
United States, North Carolina
Richard H. Weisler, MD & Associates Recruiting
Raleigh, North Carolina, United States, 27609-9148
United States, Ohio
University of Cincinnati Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Case Western Reserve School of Medicine Recruiting
Cleveland, Ohio, United States, 44106
Wexner Medical Center at the Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
IPS Research Company Recruiting
Oklahoma City, Oklahoma, United States, 73103
United States, Tennessee
Clinical NeuroScience Solutions, Inc Withdrawn
Memphis, Tennessee, United States, 38119
United States, Texas
The University of Texas at Austin Department of Psychiatry, Dell Medical School Recruiting
Austin, Texas, United States, 78712-1873
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Texas Tech University Health Sciences Center - El Paso Recruiting
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC Identifier: NCT03017781     History of Changes
Other Study ID Numbers: CR108257
NOPRODBIP0001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019

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