eural, Genetic, and Peripheral Correlates of SSRI Pharmaco-Response
- Conditions
- Major Depressive Disorder (MDD) remains to be under-recognized and under-treated, though it is amongst the leading causes of disease burden worldwide. Despite the proven efficacy of modern antidepressants, response rates are still unsatisfying, since a substantial number of patients shows only limited response or fails to respond at all and high risk of relapse remains even when remission is achieved.
- Registration Number
- EUCTR2010-023446-70-AT
- Lead Sponsor
- Med. Univ. Wien, Univ. Klinik für Psychiatrie und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
•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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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 primary objective of this study is to relate functional and structural MR parameters (e.g. local and system level BOLD signal, gray matter, structural connectivity, surface and parcellation measures) to drug response and remission.<br>;Secondary Objective: A further objective of this study is the investigation of the potential use of mRNA expression levels of SLC6A4, BDNF and HTR1A and serotonin uptake as peripheral correlates of neural markers of drug response. <br>An additional objective of this study is to relate genetic variation of SLC6A4, BDNF and HTR1A to neuronal makers of treatment response (e.g. amygdala response differs between responders and non-responders as a function of genotype). <br>;Primary end point(s): Primary outcome variables are functional and structural MRI parameters dependent on drug response and remission.
- Secondary Outcome Measures
Name Time Method