Neural, Genetic, and Peripheral Correlates of SSRI Pharmaco-Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Lukas Pezawas, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01251471
First received: December 1, 2010
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

The aim of this pharmaco-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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • BOLD signal [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram
Escitalopram, p.o., 10 mg/d; optional 20 mg/d after 2 weeks for 8 weeks
Drug: Escitalopram
10 mg/d; optional 20 mg/d after 2 weeks.
Other Names:
  • Lexapro
  • Cipralex
  • Seroplex
  • Lexamil

Detailed Description:

The aim of this pharmaco-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
Criteria

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
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: NCT01251471

Contacts
Contact: Lukas Pezawas, MD 004314040035680 lukas.pezawas@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Dept. of Psychiatry and Psychotherapy Recruiting
Vienna, Austria, 1090
Contact: Lucie Bartova       lucie.bartova@meduniwien.ac.at   
Principal Investigator: Lukas Pezawas, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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: October 1, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
major depressive disorder
MDD
imaging genetics
pharmacoMRI

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 02, 2014