Neural, Genetic, and Peripheral Correlates of SSRI Pharmaco-Response
NCT ID: NCT01251471
Last Updated: 2016-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
26 participants
INTERVENTIONAL
2011-08-31
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Thirty Major Depressive Disorder (MDD) patients with a concurrent major depressive episode will undergo three MRI scanning sessions after escitalopram treatment initiation. Furthermore, extensive behavioral assessments and measures of potential peripheral markers such lymphocyte mRNA or pharmacological parameters on platelets or lymphocytes will be performed.
Imaging measures have been suggested to be superior for drug response assessment as compared to psychometric scales, which hardly correlate with biological parameters. Since imaging techniques are too expensive and sophisticated for a broad clinical use, this study will provide pilot data on potential peripheral biomarkers of neural activation being related to drug response.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Thirty Major Depressive Disorder (MDD) patients with a concurrent major depressive episode will undergo three MRI scanning sessions at baseline, 4 hours and 8 weeks after escitalopram treatment initiation. During each MRI session, one structural and 3 fMRI scans each engaging different brain circuitries will be performed. All subjects will undergo extensive behavioral assessment and will be genotyped. Furthermore, potential peripheral markers such lymphocyte mRNA or pharmacological parameters on platelets or lymphocytes will be assessed.
The investigators expect that genetic variants which have been associated with variable response to SSRIs in previous Imaging Genetics studies are modulating neural targets of drug response. Moreover, peripheral markers are expected to correlate with these brain region measurements.
Imaging measures have been suggested to be superior for drug response assessment as compared to psychometric scales, which hardly correlate with biological parameters. Since imaging techniques are too expensive and sophisticated for a broad clinical use, this study will provide pilot data on peripheral biomarkers of neural activation being related to drug response. Furthermore, this study will demonstrate whether and how genotypes impact on the dynamics of neural drug response in vivo.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Escitalopram
Escitalopram, p.o., 10 mg/d; optional 20 mg/d after 2 weeks for 8 weeks
Escitalopram
10 mg/d; optional 20 mg/d after 2 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Escitalopram
10 mg/d; optional 20 mg/d after 2 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 18 -45 years
* Right-handedness
* DSM-IV diagnosis of a major depressive episode (SCID)
* a MADRS score ≥20 and ≤ 30
* ability to be managed as outpatients
* ability to fulfill the criteria to undergo an MRI scan
* Caucasian subjects of European ancestry
Exclusion Criteria
* clinically significant abnormal values in routine laboratory screening or general physical examination
* DSM-IV diagnosis of substance dependence within the past year, except for caffeine or nicotine or current substance abuse
* DSM-IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or an anxiety disorder as a primary diagnosis
* the use of any psychotropic drug within the last two months unresponsiveness of a former major depressive episode to an adequate antidepressive drug dosing of at least 6 weeks duration or any kind of therapy resistance
* a history of severe drug allergy or hypersensitivity or known hypersensitivity to escitalopram
* being acutely suicidal either indicated by a score ≥ 5 on item 10 (suicidal thoughts) on the MADRS or a score ≥ 4 on the HAM-D 21 (suicidal thoughts) or according to the investigator´s opinion
* failures to comply with the study protocol or to follow the instructions of the investigating team
* current pregnancy or breast feeding
* metallic implants or other contraindications to MRI
18 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Vienna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lukas Pezawas
Lukas Pezawas, MD, Medical University of Vienna
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lukas Pezawas, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
Vienna, Vienna, Austria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Scharinger C, Rabl U, Sitte HH, Pezawas L. Imaging genetics of mood disorders. Neuroimage. 2010 Nov 15;53(3):810-21. doi: 10.1016/j.neuroimage.2010.02.019. Epub 2010 Feb 13.
Pezawas L, Meyer-Lindenberg A. Imaging genetics: Progressing by leaps and bounds. Neuroimage. 2010 Nov 15;53(3):801-3. doi: 10.1016/j.neuroimage.2010.08.001. No abstract available.
Rabl U, Scharinger C, Muller M, Pezawas L. Imaging genetics: implications for research on variable antidepressant drug response. Expert Rev Clin Pharmacol. 2010 Jul;3(4):471-89. doi: 10.1586/ecp.10.35.
Related Links
Access external resources that provide additional context or updates about the study.
Dep. Psychiatry and Psychotherapy
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OENB-13903
Identifier Type: -
Identifier Source: org_study_id