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

NCT01251471 | Completed Phase 4 DMC

• 1 other identifier: OENB-13903
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

major depressive disorder; MDD; imaging genetics; pharmacoMRI

Outcome Measures

Primary Outcomes (1)

• BOLD signal

  8 weeks

Study Arms (1)

Escitalopram

EXPERIMENTAL

Escitalopram, p.o., 10 mg/d; optional 20 mg/d after 2 weeks for 8 weeks

Drug: Escitalopram

Interventions

Escitalopram DRUG

10 mg/d; optional 20 mg/d after 2 weeks.

Also known as: Lexapro, Cipralex, Seroplex, Lexamil

Escitalopram

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

Vienna, Vienna, 1090, Austria

Location

Related Publications (3)

• 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.

  PMID: 20156570 BACKGROUND

• 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.

  PMID: 20816317 BACKGROUND

• 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.

  PMID: 22111678 BACKGROUND

Related Links

• Dep. Psychiatry and Psychotherapy

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lukas Pezawas, MD

  Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lukas Pezawas, MD, Medical University of Vienna

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: August 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: March 1, 2015
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

AU (1)