<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03017781</url>
  </required_header>
  <id_info>
    <org_study_id>CR108257</org_study_id>
    <secondary_id>NOPRODBIP0001</secondary_id>
    <nct_id>NCT03017781</nct_id>
  </id_info>
  <brief_title>A Study of the Relationship of Psychosocial Function With Mood Symptoms in Offspring of Parents With Bipolar Disorder</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to compare, over 24 months, the time spent with&#xD;
      clinically significant mood symptoms (ie, mania, depression), as measured by the Longitudinal&#xD;
      Interval Follow-Up Evaluation (LIFE) and the Psychiatric Status Rating Scale (PSR), in&#xD;
      offspring of bipolar parents with and without at least mild impairment in psychosocial&#xD;
      functioning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2016</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Functioning (GAF)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bipolar Prodrome Symptom Interview and Scale-Prospective (BPSS-P)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini International Neuropsychiatric Interview (MINI)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>MINI is a short, structured diagnostic interview for psychiatric disorders, divided into modules identified by letters, each corresponding to a diagnostic category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological Testing</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Neuropsychological testing will be performed using a computerized test battery, as well as &quot;paper-based&quot; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Behavioral Inventory (GBI)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life as Assessed Using the Qol (EQ-5D-5L) Scale</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">224</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>A group of offspring of bipolar parents with no impairment in psychosocial functioning will be used for comparison.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and Saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Offspring of parents with Bipolar Disprder (BD) will be recruited primarily at selected&#xD;
        sites which are already conducting research in prodromal BD and have the necessary setup&#xD;
        and resources already in place to conduct such a study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have at least one parent who meets the criteria for diagnosis of&#xD;
             Bipolar I disorder (BD-I) or Bipolar II disorder (BD-II), as confirmed by the Mini&#xD;
             International Neuropsychiatric Interview (MINI) administered to the parent. MINI will&#xD;
             be administered to parent if the history of BD is endorsed by Family Index of Risk for&#xD;
             Mood (FIRM) or other medical information (psychiatrist, medical records). The MINI can&#xD;
             be administered to the parent remotely through the telephone or video call if an&#xD;
             in-person interview is not feasible due to logistical reasons. A diagnosis Bipolar&#xD;
             Disorder Not Otherwise Specified in the parent would not qualify for eligibility&#xD;
&#xD;
          -  Participants must be either drug-naive, or on stable treatment for at least 4 weeks.&#xD;
&#xD;
          -  Participants (and/or their parents as applicable) must sign an Informed Consent Form&#xD;
             (ICF) allowing data collection and source data verification in accordance with local&#xD;
             requirements and/or sponsor policy. Adolescents (minors) who in the judgment of the&#xD;
             investigator are capable of understanding the nature of the study can be enrolled only&#xD;
             after obtaining consent of a legally acceptable representative. Assent must be&#xD;
             obtained from any participating adolescents (minors), if applicable&#xD;
&#xD;
          -  Participants must be willing and able to complete self-reported assessments via mobile&#xD;
             electronic device, and to wear a wrist actigraphy device for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV Diagnosis of bipolar I&#xD;
             or bipolar II disorder&#xD;
&#xD;
          -  DSM-IV Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder&#xD;
&#xD;
          -  DSM-IV Diagnosis of neurodevelopmental disorders&#xD;
&#xD;
          -  An intelligence quotient (IQ) score less than (&lt;) 80 as determined by Kaufman Brief&#xD;
             Intelligence Test (K-BIT)&#xD;
&#xD;
          -  Uncorrected hypothyroidism or hyperthyroidism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Culver City</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lemon Grove</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glen Oaks</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bipolar</keyword>
  <keyword>High-Risk Off-Spring</keyword>
  <keyword>Psychosocial Functioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03017781
org study id: CR108257
secondary id: NOPRODBIP0001
nct id: NCT03017781
lead sponsor: 
has dmc: No
is fda regulated device: No
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.
observational model: Case-Control
time perspective: Prospective
measure: 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
description: 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.
measure: 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
description: 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.
measure: Global Assessment of Functioning (GAF)
time frame: Up to 24 months
description: 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.
measure: Bipolar Prodrome Symptom Interview and Scale-Prospective (BPSS-P)
time frame: Up to 24 months
description: 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.
measure: Mini International Neuropsychiatric Interview (MINI)
time frame: Up to 24 months
description: MINI is a short, structured diagnostic interview for psychiatric disorders, divided into modules identified by letters, each corresponding to a diagnostic category.
measure: Neuropsychological Testing
time frame: Up to 24 months
description: 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.
measure: General Behavioral Inventory (GBI)
time frame: Up to 24 months
description: 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).
measure: Changes in Quality of Life as Assessed Using the Qol (EQ-5D-5L) Scale
time frame: Up to 24 months
description: 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.
arm group label: Study Group
description: 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
arm group label: Control Group
description: A group of offspring of bipolar parents with no impairment in psychosocial functioning will be used for comparison.
Blood and Saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 25 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: United States
responsible party type: Sponsor
mesh term: Bipolar Disorder