Major Depressive Disorder Anxiety Disorder
Conditions
Interventions
Trade Name: Cipralex
Product Name: Cipralex
Pharmaceutical Form: Tablet
INN or Proposed INN: ESCITALOPRAM
CAS Number: 219861-08-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients: Inclusion criteria for patients are (i) a DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) by a structured clinical interview (SCID); (ii) aged 18 to 50 years; (iii) drug-free within the last three months prior inclusion; (iv) willingness and competence to sign the informed consent form. Inclusion criteria for remitted subjects: Inclusion criteria for remitted subjects are (i) a previous DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) but no symptoms at present, determined by SCID; (ii) aged 18-50 years; (iii) drug-free within the last three months prior inclusion; (iv) willingness and competence to sign the informed consent form. Inclusion criteria for healthy control subjects: Inclusion criteria for healthy control subjects are (i) willingness and competence to sign the informed consent form; (ii) aged 18-50 years; (iii) drug-free 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 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion and removal criteria for study participants: Exclusion criteria for study participants are (i) concomitant major internal or neurological illness; (ii) concomitant psychiatric disorders (except depression and anxiety for patients, excluding PTSD, claustrophobia and bipolar disorder); (iii) ingestion of any antipsychotic, antidepressant, or anti-anxiety agent within the last three months prior to the screening visit; (iv) current substance abuse; (v) failure to comply with the study protocol or to follow the instructions of the investigating team. The appearance of transient side effects of the study medication, such as nausea, agitation or gastrointestinal conditions will not cause removal of subjects in the first place. Patients experiencing continuing side effects from medication such as sexual dysfunction will be subjected to a change of medication to mirtazapine. This will cause the removal from further study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: MAN-BIOPSY pursues the concrete research question whether novel biological and psycho-physiological clusters or categories can be defined to improve treatment and minimize side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and endocrinological parameters. One major aspect of our research approach is its focuses on the identification of dysfunctions in fundamental information processing mechanisms and neurocomputational mechanisms, and is not restricted to symptom-oriented tasks. The main objectives of MAN-BIOPSY are therefore • to identify biological and psycho-physiological parameters for major depressive disorders and anxiety disorders, and • to identify predictive markers for treatment response and type/severity of side effects for these disorders. ;Secondary Objective: no secondary objectives of the trial;Primary end point(s): - functional MRI data (BOLD response) - structural MRI data - EEG data (ERPs) - DNA - hormone levels - treatment efficacy - side effects profile;Timepoint(s) of evaluation of this end point: 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): no secondary end points;Timepoint(s) of evaluation of this end point: no timepoints | — |
Countries
Austria
Contacts
Public ContactDepartment of Psychiatry
Medical University of Vienna
Outcome results
None listed