MedDataX Logo

Whole-body Hyperthermia for Mild to Moderate Depressive Disorder

NCT ID: NCT03906175

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-11

Study Completion Date

2023-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in comparison to wait list on depressive symptom severity in patients with mild to moderate depressive disorder currently not under psychotherapeutic or antidepressant drug treatment.

Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression, Unipolar

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Depression Hyperthermia Randomized Controlled Trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Whole-body hyperthermia

Whole-body hyperthermia will be applied 2 times during 4 weeks. 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.

Group Type EXPERIMENTAL

Whole-body hyperthermia

Intervention Type DEVICE

Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization). The hyperthermia will be applied using Heckel-HT3000 MPIIb.

Wait list

Participants will wait for 6 weeks (primary outcome assessment point). They will then receive the same treatment procedure as the experimental group. They will also be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whole-body hyperthermia

Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization). The hyperthermia will be applied using Heckel-HT3000 MPIIb.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Unipolar depression (diagnosed according to the DSM-IV)
* Mild depression: 8-16 points on the HAMD-17 or moderate depression: 17-23 points on the HAMD-17

Exclusion Criteria

* Current psychotherapy
* Antidepressant drug treatment in the last 4 weeks before study inclusion
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Holger Cramer

Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gustav Dobos, Prof. MD

Role: STUDY_DIRECTOR

Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-Mitte

Essen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18-8439-BO

Identifier Type: -

Identifier Source: org_study_id