Assessment of Neurobiological Markers using different methodologies for Psychiatric Disorders

Phase 1

Conditions: Major Depressive DisorderAnxiety Disorder
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2011-004860-31-AT

Lead Sponsor: Medical University of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

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 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.