Major Depressive DisorderNCT05778643
TaKeTiNa in the Treatment of Depression: a Pilot Study.
A study testing TaKeTiNa music therapy in people with Major Depressive Disorder, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- TaKeTiNa music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depressive disorder Ability to walk, speak, and clap
Who cannot join
- psychotic symptoms
- acute suicidality
- prior intolerance to body therapeutic methods
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Erlangen - Psychiatric Clinic
Erlangen, Bavaria, 91054
Johannes Kornhuber, MD, +4991318534166, direktion-psych@uk-erlangen.de
About this 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.
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
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- TaKeTiNa music therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaKeTiNa music therapyBehavioural
TaKeTiNa music therapy uses a group to perform music together. Each member of the group is needed for the synchronization of the whole group. The group actively makes Music with hands, feet, and the voice. At the same time, the therapist frequently introduces new elements into the process and challenges the group in this playful manner. Through this, patients consistently report an increase in mindful awareness and an alleviation of many depressive symptoms, although these effects have not been shown in controlled studies yet.
| Study group | Role | What they receive |
|---|---|---|
| TaKeTiNa | Experimental | Participants receive TaKeTiNa Music therapy Receives: Behavioral: TaKeTiNa music therapy |
| Waiting | No intervention | Participants receive no additional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of depression severity (HAMD 17)
Comparison of depression severity (HAMD 17) in the intervention group from beginning of Therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Secondary outcomes (12)
Differences in Depression severity (BDI II)
Differences in Depression severity in the Intervention Group compared to the Control Group , Assessment through BDI II Questionaire
Measured: four month
Differences in anxiety (BAI)
Differences in anxiety in the Intervention Group compared to the Control Group and in comparison to pre-intervention , Assessment through BAI Questionaire
Measured: four month
Differences in social anxiety
Differences in anxiety in the Intervention Group compared to the Control Group and in comparison to pre-intervention , Assessment through social phobia intentory (SPIN), social interaction anxiety scale (SIAS), social phobia scale (SPS)
Measured: four month
Differences in enzymes of sphingolipid metabolism
Differences in enzymes of sphingolipid metabolism in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Differences in Composition of adaptive cellular immunity
Differences in Composition of adaptive cellular immunity in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Differences in Adverse events
Differences in Adverse events in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Differences in Mindful Attention and Awareness
Differences in MAAS in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Differences in Resilience
Differences in RS-25 in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Differences in Physical activity
Differences in Physical activity measured by pedometer in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Differences in Heart rate variability
Differences in Heart rate variability in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Differences in Cortisol levels
Differences in Cortisol levels in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Differences in serum lipid levels
Differences in serum lipid levels in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Measured: four month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Mar 2023
- Primary completion14 Feb 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia von Zimmermann, MD, Study chair, UK Erlangen-Nurnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778643
- Sponsor's protocol ID
- P066
- Status last verified
- Dec 2022
- First submitted
- 21 Feb 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05778643
- Acronym / sponsor ID
- P066
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 14 Feb 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TaKeTiNa | Experimental | Behavioral: TaKeTiNa music therapyParticipants receive TaKeTiNa Music therapy |
| Waiting | No intervention | –Participants receive no additional therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major depressive disorder Ability to walk, speak, and clap
Key exclusion criteria (3 listed)
- psychotic symptoms
- acute suicidality
- prior intolerance to body therapeutic methods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaKeTiNa music therapyTaKeTiNa music therapy uses a group to perform music together. Each member of the group is needed for the synchronization of the whole group. The group actively makes Music with hands, feet, and the voice. At the same time, the therapist frequently introduces new elements into the process and challenges the group in this playful manner. Through this, patients consistently report an increase in mindful awareness and an alleviation of many depressive symptoms, although these effects have not been shown in controlled studies yet. | Behavioural | TaKeTiNa |
Primary outcome
Comparison of depression severity (HAMD 17)
Time frame: four month
Comparison of depression severity (HAMD 17) in the intervention group from beginning of Therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
12 secondary outcomes
Differences in Depression severity (BDI II)
Time frame: four month
Differences in anxiety (BAI)
Time frame: four month
Differences in social anxiety
Time frame: four month
Differences in enzymes of sphingolipid metabolism
Time frame: four month
Differences in Composition of adaptive cellular immunity
Time frame: four month
Differences in Adverse events
Time frame: four month
Differences in Mindful Attention and Awareness
Time frame: four month
Differences in Resilience
Time frame: four month
Differences in Physical activity
Time frame: four month
Differences in Heart rate variability
Time frame: four month
Differences in Cortisol levels
Time frame: four month
Differences in serum lipid levels
Time frame: four month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia von Zimmermann, MD study chair
UK Erlangen-Nurnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TaKeTiNa music therapy in people with Major Depressive Disorder, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia von Zimmermann, MD (0049 9131 85 33001, Claudia.von.Zimmermann@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of depression severity (HAMD 17) (time frame: four month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.