Prefrontal brain networks for cognitive flexibility in cognitive task for humans.

Phase 1

• Conditions: Major depressive disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-004018-33-AT
• Lead Sponsor: Department of Psychiatry and Psychotherapy, Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-30
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- General health based on medical history, physical examination and structured clinical interview for
DSM-IV (SCID)
- Diagnosis of a moderate to severe depressive episode without psychotic symptoms (ICD diagnosis
F32.1-2, F33.1-2) for the patients suffering from MDD
- Hamilton Depression Scale (HAM-D 17-item)=18 (depressed patients only)
- Age 18 to 55 years
- Willingness and competence to sign the informed consent form.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any medical, psychiatric or neurological illness (other than depression)
- Psychopharmacological treatment within 3 months prior to inclusion
- Pregnancy
- Any implant or stainless steel graft or any other contraindications for MRI.
- Body mass index <17 or >30 (Erritzoe, Frokjaer et al. 2010)
- Current or former substance abuse
- Failure to comply with the study protocol or to follow the instruction of the investigating team.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified