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



Status:Recruiting
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:15 - 25
Updated:2/13/2019
Start Date:October 2016
End Date:April 2021
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:
Email:JNJ.CT@sylogent.com

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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

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.


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
We found this trial at
22
sites
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Austin, TX
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Cincinnati, Ohio 45220
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2109 Adelbert Road
Cleveland, Ohio 44106
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Culver City, California 90230
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El Paso, TX
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Glen Oaks, New York 11004
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Lemon Grove, California 91945
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Los Angeles, California 90095
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Memphis, Tennessee 38119
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Oklahoma City, Oklahoma 73103
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Panorama City, California 91402
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Raleigh, North Carolina 27609
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Rochester, New York 14618
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Saint Louis, Missouri 63110
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401 Quarry Road
Stanford, California 64305
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3212 Cove Bend Drive
Tampa, Florida 33613
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