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Systematic Genetic Analysis of Phenomenology and Treatment Response in Mood Disorders

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
The Cleveland Foundation
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01769859
First received: January 11, 2013
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

The primary goals of this work are: a) to establish a unique collection of mood disorder patients across the life cycle, including children, adults and geriatric patients, with well-defined medical co-morbidities and medication treatment outcomes at the University Hospitals Case Medical Center Department of Psychiatry; b) to establish a collection of nuclear families, including both mothers and fathers, of children diagnosed with mood disorders; c) to perform a systematic genetic analysis of the proposed sample repository to identify genes and genetic variants contributing to inter-patient variability in clinical phenotypes and treatment responses. Our primary hypothesis is that genetic variations may underlie individual variability in disease susceptibility, clinical phenotypes and treatment safety, tolerability, and effectiveness.


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
Official Title: Systematic Genetic Analysis of Phenomenology and Treatment Response in Mood Disorders

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)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 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

Only clinical patients or research participants seen within the Department of Psychiatry at UHCMC will be approached for participation in this study.

Inclusion Criteria:

  • Patients must give consent/assent 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 or must be the parent of a child diagnosed with Bipolar Disorder or Major Depressive Disorder
  • Patients must be at least 7 years old
  • Patients must be willing to give a blood or a saliva sample
  • Permission from guardian if participant in under 18

Exclusion Criteria:

  • Patient is not diagnosed with Diagnostic and Statistical Manual-IV (DSM-IV) bipolar disorder, or Major Depressive Disorder
  • Patient lacks the capacity to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769859

Sponsors and Collaborators
University Hospital Case Medical Center
The Cleveland Foundation
Investigators
Principal Investigator: Jinbi Fan, PhD Case Western Reserve University / University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01769859     History of Changes
Other Study ID Numbers: Fan General, KL2TR000440
Study First Received: January 11, 2013
Last Updated: October 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Bipolar Disorder
Major Depressive Disorder
Genetics

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

ClinicalTrials.gov processed this record on November 23, 2014