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

Description

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.

Study Start Date

October, 25 2016

Estimated Completion Date

September 2020

Interventions

No interventions cited

Study ID

Janssen Research & Development, LLC -- CR108257

Status

Recruiting

Trial ID

NCT03017781

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

208

Sponsor

Janssen Research & Development, LLC

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

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

Gender

All

Ages

15 Years to 25 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (80)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
The Zucker Hillside Hospital - Glen Oaks, New York 175.7 miles None None None
The Zucker Hillside Hospital - Glen Oaks, New York 175.7 miles None None None
The Zucker Hillside Hospital - Glen Oaks, New York 175.7 miles None None None
The Zucker Hillside Hospital - Glen Oaks, New York 175.7 miles None None None
The Zucker Hillside Hospital - Glen Oaks, New York 175.7 miles None None None
Johns Hopkins University School of Medicine - Baltimore, Maryland 356.4 miles None None None
Johns Hopkins University School of Medicine - Baltimore, Maryland 356.4 miles None None None
Johns Hopkins University School of Medicine - Baltimore, Maryland 356.4 miles None None None
Johns Hopkins University School of Medicine - Baltimore, Maryland 356.4 miles None None None
Johns Hopkins University School of Medicine - Baltimore, Maryland 356.4 miles None None None
Case Western Reserve School of Medicine - Cleveland, Ohio 544.0 miles None None None
Case Western Reserve School of Medicine - Cleveland, Ohio 544.0 miles None None None
Case Western Reserve School of Medicine - Cleveland, Ohio 544.0 miles None None None
Case Western Reserve School of Medicine - Cleveland, Ohio 544.0 miles None None None
Case Western Reserve School of Medicine - Cleveland, Ohio 544.0 miles None None None
Wexner Medical Center at the Ohio State University - Columbus, Ohio 641.8 miles None None None
Wexner Medical Center at the Ohio State University - Columbus, Ohio 641.8 miles None None None
Wexner Medical Center at the Ohio State University - Columbus, Ohio 641.8 miles None None None
Wexner Medical Center at the Ohio State University - Columbus, Ohio 641.8 miles None None None
Wexner Medical Center at the Ohio State University - Columbus, Ohio 641.8 miles None None None
University of Cincinnati Hospital - Cincinnati, Ohio 737.9 miles None None None
University of Cincinnati Hospital - Cincinnati, Ohio 737.9 miles None None None
University of Cincinnati Hospital - Cincinnati, Ohio 737.9 miles None None None
University of Cincinnati Hospital - Cincinnati, Ohio 737.9 miles None None None
University of Cincinnati Hospital - Cincinnati, Ohio 737.9 miles None None None
Indiana University - Indianapolis, Indiana 805.0 miles None None None
Indiana University - Indianapolis, Indiana 805.0 miles None None None
Indiana University - Indianapolis, Indiana 805.0 miles None None None
Indiana University - Indianapolis, Indiana 805.0 miles None None None
Indiana University - Indianapolis, Indiana 805.0 miles None None None
Washington University - Saint Louis, Missouri 1,038.5 miles None None None
Washington University - Saint Louis, Missouri 1,038.5 miles None None None
Washington University - Saint Louis, Missouri 1,038.5 miles None None None
Washington University - Saint Louis, Missouri 1,038.5 miles None None None
Washington University - Saint Louis, Missouri 1,038.5 miles None None None
Clinical NeuroScience Solutions Inc - Memphis, Tennessee 1,128.4 miles None None None
Clinical NeuroScience Solutions Inc - Memphis, Tennessee 1,128.4 miles None None None
Clinical NeuroScience Solutions Inc - Memphis, Tennessee 1,128.4 miles None None None
Clinical NeuroScience Solutions Inc - Memphis, Tennessee 1,128.4 miles None None None
Clinical NeuroScience Solutions Inc - Memphis, Tennessee 1,128.4 miles None None None
Stedman Medical Trials - Tampa, Florida 1,177.4 miles None None None
Stedman Medical Trials - Tampa, Florida 1,177.4 miles None None None
Stedman Medical Trials - Tampa, Florida 1,177.4 miles None None None
Stedman Medical Trials - Tampa, Florida 1,177.4 miles None None None
Stedman Medical Trials - Tampa, Florida 1,177.4 miles None None None
Stanford Department of Psychiatry and Behavioral Sciences - Stanford, California 1,195.7 miles None None None
Stanford Department of Psychiatry and Behavioral Sciences - Stanford, California 1,195.7 miles None None None
Stanford Department of Psychiatry and Behavioral Sciences - Stanford, California 1,195.7 miles None None None
IPS Research Company - Oklahoma City, Oklahoma 1,493.9 miles None None None
IPS Research Company - Oklahoma City, Oklahoma 1,493.9 miles None None None
IPS Research Company - Oklahoma City, Oklahoma 1,493.9 miles None None None
IPS Research Company - Oklahoma City, Oklahoma 1,493.9 miles None None None
IPS Research Company - Oklahoma City, Oklahoma 1,493.9 miles None None None
University of Texas Southwestern Medical Center - Dallas, Texas 1,551.5 miles None None None
University of Texas Southwestern Medical Center - Dallas, Texas 1,551.5 miles None None None
University of Texas Southwestern Medical Center - Dallas, Texas 1,551.5 miles None None None
University of Texas Southwestern Medical Center - Dallas, Texas 1,551.5 miles None None None
University of Texas Southwestern Medical Center - Dallas, Texas 1,551.5 miles None None None
The University of Texas at Austin - Austin, Texas 1,695.2 miles None None None
The University of Texas at Austin - Austin, Texas 1,695.2 miles None None None
The University of Texas at Austin - Austin, Texas 1,695.2 miles None None None
The University of Texas at Austin - Austin, Texas 1,695.2 miles None None None
The University of Texas at Austin - Austin, Texas 1,695.2 miles None None None
Texas Tech University Health Sciences Center El Paso - El Paso, Texas 2,068.0 miles None None None
Texas Tech University Health Sciences Center El Paso - El Paso, Texas 2,068.0 miles None None None
Texas Tech University Health Sciences Center El Paso - El Paso, Texas 2,068.0 miles None None None
Texas Tech University Health Sciences Center El Paso - El Paso, Texas 2,068.0 miles None None None
Texas Tech University Health Sciences Center El Paso - El Paso, Texas 2,068.0 miles None None None
Asclepes Research - Panorama City, California 2,600.0 miles None None None
Asclepes Research - Panorama City, California 2,600.0 miles None None None
Asclepes Research - Panorama City, California 2,600.0 miles None None None
Proscience Research Group - Culver City, California 2,604.6 miles None None None
UCLA Semel Institute - Los Angeles, California 2,605.2 miles None None None
UCLA Semel Institute - Los Angeles, California 2,605.2 miles None None None
UCLA Semel Institute - Los Angeles, California 2,605.2 miles None None None

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