Factors influencing Antidepressant (SSRI) Drug Response: Impact of Stress-related Genes

Phase 1

Conditions: Major Depressive Disorder
Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

Registration Number: EUCTR2011-005001-78-AT

Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Psychiatrie u. Psychotherapie, Abteil. für biologische Psychiatrie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

- willingness and competence to sign the informed consent form voluntarily
- aged 18 – 45 years
- right-handedness
- a DSM-IV diagnosis of a major depressive episode by a structured clinical interview (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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this trial is to relate functional and structural MR parameters (e.g. local and system level BOLD signal, gray matter, functional and structural connectivity, surface and parcellation measures) to drug response and remission.;Secondary Objective: A secondary objective of this trial is to relate genetic variation of SLC6A4, BDNF, HTR1A, NR3C1 and FKBP5 to neural markers of treatment response. An additional objective is to investigate the potential use of peripheral parameters such as mRNA transcription and protein expression levels of these genes as well as 5-HT uptake and cortisol levels as peripheral correlates of neural markers of drug response.;Primary end point(s): Primary outcome variables are functional and structural MRI parameters dependent on drug response and remission. ;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated 8 weeks after escitalopram treatment initiation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcome variables will be genotype-mediated drug response and association between peripheral parameters (such as mRNA expression levels, serotonin uptake, cortisol levels) and drug response. ;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated 8 weeks after escitalopram treatment initiation.