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The efficacy and safety of adjunctive hyperbaric oxygen therapy for adolescents with major depressive disorder: a randomised single-blind controlled study

The efficacy and safety of adjunctive hyperbaric oxygen therapy for adolescents with major depressive disorder: a randomised single-blind controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096516
Enrollment
Unknown
Registered
2025-01-24
Start date
2025-03-10
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major depressive disorder

Interventions

HBOT + Medication group:HBOT + medication therapy
Medication group:Medication therapy

Sponsors

Chaohu Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) diagnosed as major depressive disorder that meets the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), as determined by a structured clinical interview with two psychiatrists of attending grade and above; (2) 17-item Hamilton Depression Scale (HAMD) score >= 18 at enrolment; (3) aged between 13 and 18 years old, right-handed, with some reading ability; (4) subjects or their guardians sign an informed consent form; (5) No antidepressant drugs prior to enrolment or off antidepressant drugs for >= 2 weeks (fluoxetine for >= 5 weeks).

Exclusion criteria

Exclusion criteria: (1) combined with other mental disorders; (2) combined with serious somatic diseases, nervous system diseases, and mental retardation; (3) unable to cooperate or uncooperative with the assessment; (4) presence of relative and absolute contraindications to hyperbaric exposure, e.g. claustrophobia, untreated pneumothorax with glaucoma, concomitant administration of disulfiram or antineoplastic drugs; (5) physical therapy such as hyperbaric oxygen therapy (HBOT), MECT, transcranial magnetic stimulation therapy, transcranial direct current therapy, and systemic psychotherapy in the previous 6 months.

Design outcomes

Primary

MeasureTime frame
Clinical symptoms;Multimodal MRI;Hematological index;Cognitive function;

Countries

China

Contacts

Public ContactLei Xia

Chaohu Hospital of Anhui Medical University

xialei@ahmu.edu.cn+86 182 5601 2080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026