Neural, Genetic, and Peripheral Correlates of SSRI Pharmaco-Response
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The aim of this pharmako-MRI study is to investigate neural correlates of variable antidepressant treatment response driven by genetic variation in multiple genes involved in depression.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Escitalopram |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Neural, Genetic, and Peripheral Correlates of SSRI Pharmaco-Response |
- BOLD signal [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Escitalopram |
Drug: Escitalopram
10 mg/d; optional 20 mg/d after 2 weeks.
Other Names:
|
Detailed Description:
The aim of this pharmako-MRI study is to investigate neural correlates of variable antidepressant treatment response driven by genetic variation in multiple genes involved in depression.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female
- 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:
- previous or concurrent major medical or neurological illness
- 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
Contacts and Locations| Contact: Lukas Pezawas, MD | 00431404003568 | lukas.pezawas@meduniwien.ac.at |
| Austria | |
| Medical University of Vienna, Dept. of Psychiatry and Psychotherapy | Not yet recruiting |
| Vienna, Austria, 1090 | |
| Contact: Lucie Bartova lucie.bartova@meduniwien.ac.at | |
| Principal Investigator: Lukas Pezawas, MD | |
| Principal Investigator: | Lukas Pezawas, MD | Medical University of Vienna, Dept. of Psychiatry and Psychotherapy |
More Information
Additional Information:
Publications:
| Responsible Party: | Lukas Pezawas, Lukas Pezawas, MD, Medical University of Vienna, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01251471 History of Changes |
| Other Study ID Numbers: | OENB-13903 |
| Study First Received: | December 1, 2010 |
| Last Updated: | August 23, 2011 |
| Health Authority: | Austrian Agency for Health and Food Safety: Austria |
Keywords provided by Medical University of Vienna:
|
major depressive disorder MDD imaging genetics pharmacoMRI |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 16, 2013