Systematic Genetic Analysis of Phenomenology and Treatment Response in Mood Disorders

This study has been terminated.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
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: June 7, 2016
Last verified: June 2016
  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

Enrollment: 396
Study Start Date: January 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

The study entails a one-time blood draw that will be used to obtain phenotypic data and DNA of all eligible mood disorders patients, and their parents (if applicable), who are treated within the Psychiatry Department at University Hospitals Case Medical Center (UHCMC). In rare instances, if a participant is unable to cooperate with a blood draw, a saliva sample will be collected instead of drawing blood. All eligible participants will be diagnosed with bipolar disorder or major depressive disorder, or be a parent of a child diagnosed with bipolar disorder or major depressive disorder, and will be seen for the study visit at the Department of Psychiatry at University Hospitals of Cleveland, 10524 Euclid Avenue, Cleveland, OH, 44106. Required lab specimens will be collected at University Hospitals Laboratory Services or the Department of Psychiatry, and analyzed at UHCMC and Case Western Reserve University (CWRU) or at an NIH sponsored sequencing or genotyping laboratory.

DNA sample from eligible subjects will undergo whole genome genetic analysis using array-based genotyping or sequencing technologies. The clinical phenotypes, treatment response profiles and genotype data will be analyzed using single and multivariate analyses in order to identify genes and genomic regions contributing to inter-patient variability in disease susceptibility, clinical phenotypes and treatment responses. Alternatively, as sequencing costs decline continuously, the DNA samples may undergo targeted genomic region deep sequencing or whole genome sequencing analysis.

Any clinical patient, research participant or parent of a child patient, seven years and older, within the Department of Psychiatry will be targeted for enrollment. Eligible participants will be diagnosed with DSM-IV bipolar disorder (type I, II, or not otherwise specified) or DSM-IV major depressive disorder, as determined by an extensive clinical interview and the Mini-International Neuropsychiatric Interview-Plus (MINI-Plus) if applicable or will be a parent of a child diagnosed with bipolar disorder or major depressive disorder.

The primary phenotype definition for the genetic analyses proposed here is DSM-IV diagnosis (BD or MDD), phenotypic variables (comorbidities etc.), and treatment response, defined either continuously (change in symptom measures) or categorically (response/non-response), made on the basis of structured diagnostic instruments.

In summary, we expect the following types of phenotypic data (as shown in the attached minimum data set CRF) to be available for majority of participants:

  • Demographic information including gender, age and ethnicity.
  • Psychiatric diagnosis and history including age of onset and course of mood disorder etc.
  • Family history of illness including psychiatric disorders, diabetes and cardiovascular diseases.

The additional clinical variables (from minimum dataset and clinical trials) may define mood disorder subtypes that are more genetically homogeneous and therefore more likely to reveal the influence of genes.

Once a participant has signed the informed consent form, a blood sample of approximately 4 teaspoons of blood, or a saliva sample of approximately half a teaspoon of saliva, will be collected for DNA extraction. The DNA samples will be linked with phenotypic data collected from the study participants. The blood draw or saliva collection and minimum data set questions are the only procedures that participants will need to complete once they decide to participate in the study. The informed consent form will specify that the demographic and diagnostic information used for this study will be taken from participation within another study or from the medical records of clinical patients; participants will not participate in this study if they do not provide consent to use their data retrospectively.

  Eligibility

Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
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
National Institutes of Health (NIH)
The Cleveland Foundation
Investigators
Principal Investigator: Jinbi Fan, PhD Case Western Reserve University / University Hospitals of Cleveland
  More Information

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: June 7, 2016
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:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Mood Disorders
Pathologic Processes
Mental Disorders
Behavioral Symptoms
Bipolar and Related Disorders

ClinicalTrials.gov processed this record on August 25, 2016