Systematic Genetic Analysis of Phenomenology and Treatment Response in Mood Disorders

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jinbo Fan, PhD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01769859
First received: January 11, 2013
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to identify genetic changes that can interact with environmental factors to influence people's susceptibility to disease and responses to medical treatments. Therefore, we would like to study the genetic materials from you as part of the study. We will compare the DNA sequence from people with certain clinical features (observable characteristics, determined by both genes and environment) and/or treatment responses to the DNA from people without those clinical features and/or medication treatment responses to find the DNA sequence differences that exist. By combining this information with information from your medical records, it may be possible to identify the genetic changes that influence people's responses to different medical treatments. This project could lead to more knowledge about why certain people respond differently to a treatment. With such knowledge, future treatments potentially could become customized to a patient's unique genetic make-up.

You will be one of participants enrolled in this research.


Condition
Bipolar Disorder
Major Depressive Disorder

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 10 Years

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Identify genetic variations contributing to inter-patient variability in disease susceptibility [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 500
Study Start Date: January 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bipolar Disorder

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mood Disorders Program of University Hospitals Case Medical Center

Criteria

Inclusion Criteria:

  • Patients must give consent to participate by signing and dating the Institutional Review Board approved written informed consent form prior to the initiation of any procedures for this study
  • Patients must be diagnosed with Bipolar Disorder or Major Depressive Disorder
  • Patients must be at least 18 years old
  • Patients must be willing to give a blood sample

Exclusion Criteria:

  • Patient is not diagnosed with Diagnostic and Statistical Manual-IV bipolar disorder, or Major Depressive Disorder
  • Patient lacks the capacity to provide informed consent
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jinbo Fan, PhD, Assistant Professor, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01769859     History of Changes
Other Study ID Numbers: Fan General
Study First Received: January 11, 2013
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depression
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 23, 2014