Neural, Genetic, and Peripheral Correlates of SSRI Pharmaco-Response
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

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.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): 10 mg/d; optional 20 mg/d after 2 weeks.
Other intervention name(s): Lexapro; Cipralex; Seroplex; Lexamil
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: major depressive disorder; MDD; imaging genetics; pharmacoMRI