NCT02756065

Brief Summary

Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with bipolar disorder and schizophrenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

4.9 years

First QC Date

June 17, 2015

Last Update Submit

February 3, 2021

Conditions

Keywords

Bipolarschizophreniaschizoaffective

Outcome Measures

Primary Outcomes (1)

  • MRI Brain Imaging

    The current project aims to uncover latent, homogenous, connectivity phenotypes using neuroimaging tools, which are free from the limitations of traditional diagnostic boundaries, and which correlate with clinical characteristics. The investigator will use resting state functional connectivity MRI (rs-fcMRI), diffusion MRI (dMRI) and tract-based spatial statistics (TBSS) to identify brain signatures that cut across schizophrenia (SZ) and bipolar (BP).

    within one month of study enrollment

Secondary Outcomes (2)

  • DNA testing through saliva

    within one month of study enrollment

  • Hair sample for cortisol measurement

    within one month of study enrollment

Study Arms (3)

Control

Individuals between 18-30 years old No diagnosis of Bipolar Disorder or Schizophrenia No intervention used

Other: no intervention

Bipolar Disorder

Individuals between 18-30 years old Diagnosis of Bipolar Disorder No intervention used

Other: no intervention

Schizophrenia

Individuals between 18-30 years old Diagnosis of Schizophrenia or Schizoaffective Disorder No intervention used

Other: no intervention

Interventions

no intervention is used

Bipolar DisorderControlSchizophrenia

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals between the ages of 18-30 with a diagnosis of Bipolar Disorder or Schizophrenia

You may qualify if:

  • Between ages 18-30

You may not qualify if:

  • Head Injury
  • Unstable Medical Condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Bipolar DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Daniel Mamah

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

April 29, 2016

Study Start

September 1, 2014

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations