The effect of interventions focussing on or leading away from actual symptoms on well-being in different states of altered neuroplasticity

Not Applicable

Recruiting

• Conditions: F32.2; F33.2; Severe depressive episode without psychotic symptoms; Recurrent depressive disorder, current episode severe without psychotic symptoms

• Registration Number: DRKS00025974
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Age group:
18 to 50 years

Sex distribution:
Patients will be enrolled in the trial independent of their sex or sexual orientation.

Mayor depressive disorder according to ICD-10: F32.2, F33.2 criteria.

2 weeks constant pharmacotherapy

Exclusion Criteria

Bipolar disorder (ICD-10: F31.X)

Co-morbid post-traumatic-stress-disease (PTSD; ICD-10: F43.1)

Co-morbid personality disorder (ICD-10: F60.X)

Co-morbid psychotic disease (ICD-10: F2X)

Co-morbid addictive disorder (ICD-10: F1X)

Current co-morbid neurological diseases (ICD-10: GX)

Co-medication with Benzodiazepines, Pregabalin, opioids, inhibitors of MAO and z-substances

Co-treatment with other stimulative treatment interventions like electroconvulsive therapy, transcranial direct current stimulation or deep brain stimulation.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WHO-5 well-being-score before and after both interventions (SIGMA and MBI) calculated as the difference of the values in dependence of the corresponding plasticity state.

Secondary Outcome Measures

Name	Time	Method
PANAS score before and after both interventions (SIGMA and MBI) calculated as the difference of the values in dependence of the corresponding plasticity state.