Skip to main content
OpenTrials
Completed

NCT Number: NCT03017781

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Culver City, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2017
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.