Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders - MAN-BIOPSY

Medical University of Vienna0 sites0 target enrollmentOctober 14, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 14, 2011

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.