Systematic Genetic Analysis of Phenomenology and Treatment Response in Mood Disorders

June 27, 2023 updated by: University Hospitals Cleveland Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
396

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years and older (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Mood Disorders Program of University Hospitals Case Medical Center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Identify genetic variations contributing to inter-patient variability in disease susceptibility
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospitals Cleveland Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
The Cleveland Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jinbo Fan, PhD, Case Western Reserve University / University Hospitals of Cleveland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fan General
  • KL2TR000440 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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