Depression, UnipolarHYPE2NCT03906149
Whole-body Hyperthermia for Moderate to Severe Depressive Disorder
A study testing Whole-body hyperthermia + standard medical care and Standard medical care in people with Depression, Unipolar, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in addition to standard medical care in comparison to standard medical care alone on depressive symptom severity in patients with moderate to severe depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Unipolar
- What is being tested?
- Whole-body hyperthermia + standard medical care and Standard medical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2019to 20 Jan 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unipolar depression (diagnosed according to the DSM-IV)
- Moderate depression: 17-23 points on the HAMD-17 or severe depression: ≥24 points on the HAMD-17
Who cannot join
- Participants who did not respond to prior antidepressant drug treatment, electroconvulsive therapy, or sleep deprivation (therapy-resistant depression)
- Acute suicidality
- Prior treatment with whole-body hyperthermia
- Contraindications to hyperthermia treatment: acute or feverish infections, severe cardiovascular diseases (e.g. angina pectoris, heart failure, thrombosis, bleeding diathesis), severe gastrointestinal diseases (e.g. renal insufficiency, hepatitis, liver cirrhosis, peptic ulcer), severe neurological diseases (e.g. epilepsy, multiple sclerosis, cerebrovascular malformations or brain tumors), severe endocrine diseases (e.g. hyperthyroidism), or oncological diseases without remission
- Participants taking anti-inflammatory or immunosuppressive drugs
- Participants with severe psychiatric comorbidities (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, dementia, ADHD, obsessive-compulsive disorder, PTSD, alcohol or drug addiction)
- Women during pregnancy and breastfeeding
- Lack of ability to consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-Mitte
Essen, 45276
About this study
Official title: Whole-body Hyperthermia for Moderate to Severe Depressive Disorder - a Randomized Controlled Tiral
The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in addition to standard medical care in comparison to standard medical care alone on depressive symptom severity in patients with moderate to severe depressive disorder.
Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.
- Conditions
- Depression, Unipolar
- Being tested
- Whole-body hyperthermia + standard medical care, Standard medical care
- Keywords
- Depression, Hyperthermia, Randomized Controlled Trial
- Medical subject headings
- Depressive Disorder, Depression, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body hyperthermia + standard medical careCombination product
Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization) in addition to standard medical care. The hyperthermia will be applied using Heckel-HT3000 MPIIb. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.
Standard medical careCombination product
Standard medical care included guideline-based anti-depressive drug treatment in combination with psychotherapy. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.
| Study group | Role | What they receive |
|---|---|---|
| Whole-body hyperthermia + standard medical care | Experimental | Whole-body hyperthermia will be applied 2 times during 4 weeks in addition to guideline-based standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia. Receives: Combination Product: Whole-body hyperthermia + standard medical care |
| Standard medical care | Active comparator | Participants will maintain standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after randomization. Receives: Combination Product: Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity: clinician-rated
Hamilton Rating Scale for Depression (HAMD-17)
Measured: week 6
Secondary outcomes (67)
Depression Severity: clinician-rated
Hamilton Rating Scale for Depression (HAMD-17)
Measured: week 1
Depression Severity: clinician-rated
Hamilton Rating Scale for Depression (HAMD-17)
Measured: week 3
Depression Severity: clinician-rated
Hamilton Rating Scale for Depression (HAMD-17)
Measured: week 12
Depression Severity: patient-rated
Beck Depression Inventory II (BDI-II)
Measured: week 1
Depression Severity: patient-rated
Beck Depression Inventory II (BDI-II)
Measured: week 3
Depression Severity: patient-rated
Beck Depression Inventory II (BDI-II)
Measured: week 6
Depression Severity: patient-rated
Beck Depression Inventory II (BDI-II)
Measured: week 12
Global improvement: clinician-rated
Clinical Global Impression Scale (CGI)
Measured: week 1
Global improvement: clinician-rated
Clinical Global Impression Scale (CGI)
Measured: week 3
Global improvement: clinician-rated
Clinical Global Impression Scale (CGI)
Measured: week 6
Global improvement: clinician-rated
Clinical Global Impression Scale (CGI)
Measured: week 12
Global Functioning: clinician-rated
Global Assessment of Functioning Scale (GAF)
Measured: week 1
Global Functioning: clinician-rated
Global Assessment of Functioning Scale (GAF)
Measured: week 3
Global Functioning: clinician-rated
Global Assessment of Functioning Scale (GAF)
Measured: week 6
Global Functioning: clinician-rated
Global Assessment of Functioning Scale (GAF)
Measured: week 12
Fatigue: patient-rated
Multidimensional Fatigue Inventory (MFI)
Measured: week 1
Fatigue: patient-rated
Multidimensional Fatigue Inventory (MFI)
Measured: week 3
Fatigue: patient-rated
Multidimensional Fatigue Inventory (MFI)
Measured: week 6
Fatigue: patient-rated
Multidimensional Fatigue Inventory (MFI)
Measured: week 12
Stress: patient-rated
Perceived Stress-Scale (PSS)
Measured: week 1
Stress: patient-rated
Perceived Stress-Scale (PSS)
Measured: week 3
Stress: patient-rated
Perceived Stress-Scale (PSS)
Measured: week 6
Stress: patient-rated
Perceived Stress-Scale (PSS)
Measured: week 12
Quality of Life: patient-rated
Short Form Health Survey (SF-12)
Measured: week 1
Quality of Life: patient-rated
Short Form Health Survey (SF-12)
Measured: week 3
Quality of Life: patient-rated
Short Form Health Survey (SF-12)
Measured: week 6
Quality of Life: patient-rated
Short Form Health Survey (SF-12)
Measured: week 12
Biomarkers: interleukin 2
IL-2
Measured: week 1
Biomarkers: interleukin 2
IL-2
Measured: week 3
Biomarkers: interleukin 2
IL-2
Measured: week 6
Biomarkers: interleukin 2
IL-2
Measured: week 12
Biomarkers: interleukin 6
IL-6
Measured: week 1
Biomarkers: interleukin 6
IL-6
Measured: week 3
Biomarkers: interleukin 6
IL-6
Measured: week 6
Biomarkers: interleukin 6
IL-6
Measured: week 12
Biomarkers: interleukin 10
IL-10
Measured: week 1
Biomarkers: interleukin 10
IL-10
Measured: week 3
Biomarkers: interleukin 10
IL-10
Measured: week 6
Biomarkers: interleukin 10
IL-10
Measured: week 12
Biomarkers: tumor necrosis factor-alpha
TNF-alpha
Measured: week 1
Biomarkers: tumor necrosis factor-alpha
TNF-alpha
Measured: week 3
Biomarkers: tumor necrosis factor-alpha
TNF-alpha
Measured: week 6
Biomarkers: tumor necrosis factor-alpha
TNF-alpha
Measured: week 12
Biomarkers: high-sensitivity C-reactive Protein
hs-CRP
Measured: week 1
Biomarkers: high-sensitivity C-reactive Protein
hs-CRP
Measured: week 3
Biomarkers: high-sensitivity C-reactive Protein
hs-CRP
Measured: week 6
Biomarkers: high-sensitivity C-reactive Protein
hs-CRP
Measured: week 12
Biomarkers: soluble intercellular adhesion molecule-1
sICAM-1
Measured: week 1
Biomarkers: soluble intercellular adhesion molecule-1
sICAM-1
Measured: week 3
Biomarkers: soluble intercellular adhesion molecule-1
sICAM-1
Measured: week 6
Biomarkers: soluble intercellular adhesion molecule-1
sICAM-1
Measured: week 12
Biomarkers: tryptophan
tryptophan
Measured: week 1
Biomarkers: tryptophan
tryptophan
Measured: week 3
Biomarkers: tryptophan
tryptophan
Measured: week 6
Biomarkers: tryptophan
tryptophan
Measured: week 12
Biomarkers: kynurenine
kynurenine
Measured: week 1
Biomarkers: kynurenine
kynurenine
Measured: week 3
Biomarkers: kynurenine
kynurenine
Measured: week 6
Biomarkers: kynurenine
kynurenine
Measured: week 12
Biomarkers: neopterin
neopterin
Measured: week 1
Biomarkers: neopterin
neopterin
Measured: week 3
Biomarkers: neopterin
neopterin
Measured: week 6
Biomarkers: neopterin
neopterin
Measured: week 12
Adverse Events
Number of patients with adverse events, total number and type of adverse events
Measured: week 1
Adverse Events
Number of patients with adverse events, total number and type of adverse events
Measured: week 3
Adverse Events
Number of patients with adverse events, total number and type of adverse events
Measured: week 6
Adverse Events
Number of patients with adverse events, total number and type of adverse events
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Jul 2019
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, UnipolarStudies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study director, Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906149
- Sponsor's protocol ID
- 18-8440-BO
- Acronym
- HYPE2
- Status last verified
- Nov 2023
- First submitted
- 4 Apr 2019
- Last updated
- 22 Nov 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 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-body Hyperthermia for Moderate to Severe Depressive Disorder - a Randomized Controlled Tiral
- ClinicalTrials.gov ID
- NCT03906149
- Acronym / sponsor ID
- HYPE2 / 18-8440-BO
- Conditions
- Depression, Unipolar
- Keywords
- Depression, Hyperthermia, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 8 Apr 2019 (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 primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in addition to standard medical care in comparison to standard medical care alone on depressive symptom severity in patients with moderate to severe depressive disorder.
Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-body hyperthermia + standard medical care | Experimental | Combination Product: Whole-body hyperthermia + standard medical careWhole-body hyperthermia will be applied 2 times during 4 weeks in addition to guideline-based standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia. |
| Standard medical care | Active comparator | Combination Product: Standard medical careParticipants will maintain standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after randomization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unipolar depression (diagnosed according to the DSM-IV)
- Moderate depression: 17-23 points on the HAMD-17 or severe depression: ≥24 points on the HAMD-17
Key exclusion criteria (8 listed)
- Participants who did not respond to prior antidepressant drug treatment, electroconvulsive therapy, or sleep deprivation (therapy-resistant depression)
- Acute suicidality
- Prior treatment with whole-body hyperthermia
- Contraindications to hyperthermia treatment: acute or feverish infections, severe cardiovascular diseases (e.g. angina pectoris, heart failure, thrombosis, bleeding diathesis), severe gastrointestinal diseases (e.g. renal insufficiency, hepatitis, liver cirrhosis, peptic ulcer), severe neurological diseases (e.g. epilepsy, multiple sclerosis, cerebrovascular malformations or brain tumors), severe endocrine diseases (e.g. hyperthyroidism), or oncological diseases without remission
- Participants taking anti-inflammatory or immunosuppressive drugs
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 |
|---|---|---|
| Whole-body hyperthermia + standard medical careWhole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization) in addition to standard medical care. The hyperthermia will be applied using Heckel-HT3000 MPIIb. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed. | Combination product | Whole-body hyperthermia + standard medical care |
| Standard medical careStandard medical care included guideline-based anti-depressive drug treatment in combination with psychotherapy. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed. | Combination product | Standard medical care |
Primary outcome
Depression Severity: clinician-rated
Time frame: week 6
Hamilton Rating Scale for Depression (HAMD-17)
67 secondary outcomes
Depression Severity: clinician-rated
Time frame: week 1
Depression Severity: clinician-rated
Time frame: week 3
Depression Severity: clinician-rated
Time frame: week 12
Depression Severity: patient-rated
Time frame: week 1
Depression Severity: patient-rated
Time frame: week 3
Depression Severity: patient-rated
Time frame: week 6
Depression Severity: patient-rated
Time frame: week 12
Global improvement: clinician-rated
Time frame: week 1
Global improvement: clinician-rated
Time frame: week 3
Global improvement: clinician-rated
Time frame: week 6
Global improvement: clinician-rated
Time frame: week 12
Global Functioning: clinician-rated
Time frame: week 1
Global Functioning: clinician-rated
Time frame: week 3
Global Functioning: clinician-rated
Time frame: week 6
Global Functioning: clinician-rated
Time frame: week 12
Fatigue: patient-rated
Time frame: week 1
Fatigue: patient-rated
Time frame: week 3
Fatigue: patient-rated
Time frame: week 6
Fatigue: patient-rated
Time frame: week 12
Stress: patient-rated
Time frame: week 1
Stress: patient-rated
Time frame: week 3
Stress: patient-rated
Time frame: week 6
Stress: patient-rated
Time frame: week 12
Quality of Life: patient-rated
Time frame: week 1
Quality of Life: patient-rated
Time frame: week 3
Quality of Life: patient-rated
Time frame: week 6
Quality of Life: patient-rated
Time frame: week 12
Biomarkers: interleukin 2
Time frame: week 1
Biomarkers: interleukin 2
Time frame: week 3
Biomarkers: interleukin 2
Time frame: week 6
Biomarkers: interleukin 2
Time frame: week 12
Biomarkers: interleukin 6
Time frame: week 1
Biomarkers: interleukin 6
Time frame: week 3
Biomarkers: interleukin 6
Time frame: week 6
Biomarkers: interleukin 6
Time frame: week 12
Biomarkers: interleukin 10
Time frame: week 1
Biomarkers: interleukin 10
Time frame: week 3
Biomarkers: interleukin 10
Time frame: week 6
Biomarkers: interleukin 10
Time frame: week 12
Biomarkers: tumor necrosis factor-alpha
Time frame: week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 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.
Gustav Dobos, Prof. MD study director
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body hyperthermia + standard medical care and Standard medical care in people with Depression, Unipolar, run by Universität Duisburg-Essen 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 22 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Severity: clinician-rated (time frame: week 6). 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 Nov 2023.