Starting clinical trial at KEM
At Evangelische Kliniken Essen-Mitte, 2 randomized-controlled clinical trials, focused on the use of whole-body hyperthermia (WBH) with heckel-HT3000, have begun under the direction of Prof. Dr. med. Martin Schäfer, KEM - Psychiatry, Psychotherapy, Psychosomatics and Addiction Therapy:
HYPE1: Whole-body Hyperthermia for Mild to Moderate Depressive Disorder
Study design: https://clinicaltrials.gov/ct2/show/NCT03906175?term=Depression&cond=Hyperthermia&cntry=DE&city=Essen&rank=2
In the experimental arm, whole-body hyperthermia will be applied two times at weeks 0 and 2 after randomization. At week 6, the primary outcome will be assessed, and reassessed at week 12. In the control arm, participants will wait for 6 weeks (primary outcome assessment point). They will then receive the same treatment procedure as the experimental group. Patients do not receive any other therapies.
Primary outcome measures: Hamilton Rating Scale for Depression (HAMD-17) after 6 and 12 weeks.
Secondary outcome measures: Measures at other points in time as well as comprehensive measures with other questionnaires and assessment of various biomarkers.
HYPE2: Whole-body Hyperthermia for Moderate to Severe Depressive Disorder
Study design: https://clinicaltrials.gov/ct2/show/NCT03906149?term=Depression&cond=Hyperthermia&cntry=DE&city=Essen&rank=1
In the experimental arm, whole-body hyperthermia will be applied two times at weeks 0 and 2 after randomization in addition to guideline-based standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy).
In the control arm, patients receive only the above mentioned standard medical care.
Primary and secondary outcome measures as in HYPE1.
German Patienteninformation zu HYPE1 und HYPE2