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

Not Recruiting

Trial ID: NCT03017781


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.

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

Stanford Investigator(s)


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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305