Clinical trial NCT05778643: TaKeTiNa in the Treatment of Depression: a Pilot Study.
Official title: Immunological Mechanisms in the Treatment of Depression and Their Significance in TaKeTiNa Music Therapy as a New Psychotherapeutic Method. A Waitlist-controlled Randomized Group Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study's to analyse the impact of TaKeTiNa music therapy in depressed patients.

The main question\[s\] it aims to answer are:

. Can TaKeTiNa result in a significant pre-to-post intervention decline of depression severity 2. Can TaKeTiNa result in a significantly lower post-intervention depression severity in the T1/T2 group than in the W1/W2 group.

Participants will

* be randomly assigned to the two groups, intervention vs. waitlist
* receive either an eight week TaKeTiNa music therapy or waitlist
* be analysed using questionaires, blood taking, cortisol saliva analysis, measured heart rate variability

Researchers will compare a waitlist to see if TakeTiNa is superior to waitlist

Detailed description: One third of the depressed patients do not respond adequately to conventional treatment. This seems to be associated with increased production of proinflammatory cytokines such as TNF-a and IL-1, as well as dysregulation of cortisol levels. This project aims to investigate Investigate the effectiveness of TaKeTiNa music therapy in the treatment of patients with clinical diagnosis of moderate to severe depression Investigate the physiological and pathophysiological effects of TaKeTiNa using novel blood based biomarkers of depression, especially LDL cholesterol as well as on immune system function in order to establish immune system based biomarkers for better diagnosis and therapy monitoring of major depressive disorder.

Eligibility criteria: Inclusion Criteria:

Major depressive disorder Ability to walk, speak, and clap

Exclusion Criteria:

* psychotic symptoms
* acute suicidality
* prior intolerance to body therapeutic methods

Primary outcomes:
measure: Comparison of depression severity (HAMD 17)
timeFrame: four month
Secondary outcomes:
measure: Differences in Depression severity (BDI II)
timeFrame: four month
measure: Differences in anxiety (BAI)
timeFrame: four month
measure: Differences in social anxiety
timeFrame: four month
measure: Differences in enzymes of sphingolipid metabolism
timeFrame: four month
measure: Differences in Composition of adaptive cellular immunity
timeFrame: four month
measure: Differences in Adverse events
timeFrame: four month
measure: Differences in Mindful Attention and Awareness
timeFrame: four month
measure: Differences in Resilience
timeFrame: four month
measure: Differences in Physical activity
timeFrame: four month
measure: Differences in Heart rate variability
timeFrame: four month
measure: Differences in Cortisol levels
timeFrame: four month
measure: Differences in serum lipid levels
timeFrame: four month
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital of Erlangen - Psychiatric Clinic
state: Bavaria
Study officials:
affiliation: UK Erlangen-Nurnberg
name: Claudia von Zimmermann, MD
role: STUDY_CHAIR
References: