Systematic Genetic Analysis of Phenomenology and Treatment Response in Mood Disorders

NCT01769859 | Terminated DMC

• 2 other identifiers: Fan GeneralKL2TR000440
• Study Type: observational
• Target: 396
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bipolar Disorder; Major Depressive Disorder

Keywords

Bipolar Disorder; Major Depressive Disorder; Genetics

Outcome Measures

Primary Outcomes (1)

• Identify genetic variations contributing to inter-patient variability in disease susceptibility

  Day 1

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mood Disorders Program of University Hospitals Case Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• National Institutes of Health (NIH): collaborator
• The Cleveland Foundation: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder

Study Officials

• Jinbo Fan, PhD

  Case Western Reserve University / University Hospitals of Cleveland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 17, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 29, 2023

Record last verified: 2023-06