TaKeTiNa in the Treatment of Depression: a Pilot Study.

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Behavioral: TaKeTiNa music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05778643

P066

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Major depressive disorder Ability to walk, speak, and clap

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

TaKeTiNa

Experimental group

Description:

Participants receive TaKeTiNa Music therapy

Treatment:

Behavioral: TaKeTiNa music therapy

Waiting

No Intervention group

Description:

Participants receive no additional therapy