Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01769859 |
| Other study ID # |
Fan General |
| Secondary ID |
KL2TR000440 |
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2013 |
| Est. completion date |
May 2016 |
Study information
| Verified date |
June 2023 |
| Source |
University Hospitals Cleveland Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
