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Research on efficacy and safety of sevoflurane inhalation augmentation in treatment-resistant depression

Research on efficacy and safety of sevoflurane inhalation augmentation in treatment-resistant depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052062
Enrollment
Unknown
Registered
2021-10-16
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Treatment-resistant depression

Interventions

Group A:Sevoflurane inhalation followed by placebo
Group B:Placebo inhalation followed by sevoflurane

Sponsors

Huzhou Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of DSM-?-TR for major depressive disorder and verified by MINI clinical interview; 2. Han Chinese; Both men and women, aged 18 to 65 years; 3. HAMD-21 >= 18 points, CGI-S >= 3 points; 4. Meet the diagnostic criteria of refractory depression: during this depression attack, the efficacy of two or more antidepressants with different structures with sufficient treatment course is poor, and the treatment of antidepressants has been ineffective for three times in the past; 5. Sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Schizophrenic affective psychosis, dysthymia or bipolar depression; any other anxiety disorder was the main diagnosis within 1 year; obsession; patients with substance abuse or dependence; personality disorder; 2. Various contraindications covered in the instructions for the use of sevoflurane; 3. Pregnant or lactating women; 4. Patients with severe or unstable heart, liver, kidney, endocrine (abnormal thyroid function), blood, autoimmune diseases and other medical diseases; Patients with epilepsy or other brain organic diseases; Increased intracranial pressure, intractable and refractory hypertension, glaucoma, etc.; 5. A history of serious attempted suicide, or a high risk of suicide, or HAMD item 3 suicide score >= 3; 6. NMDA receptor antagonists such as ketamine have been used in the past; 7. Antidepressants and psychoactive drugs were used in the first 2 weeks; 8. Those who are currently undergoing standard electrical convulsion therapy, rTMS therapy or systematic psychotherapy.

Design outcomes

Primary

MeasureTime frame
Total score reduction of HAMD(Hamilton Depression Scale)-21;Montgomery-Asberg Depression Rating Scale;Hamilton Anxiety Scale;

Secondary

MeasureTime frame
Snaith-Hamilton Pleasure Scale;Beck Scale for Suicide Ideation;Multidimensional Fatigue Scale;Clinical Global Impression Scale;

Countries

China

Contacts

Public ContactWang Shikai

Huzhou Third People's Hospital

wang-shikai@163.com+86 13665752769

Outcome results

None listed

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