Skip to content

A multicenter randomized controlled clinical trial for evaluation of efficacy and safety of adjunctive low-concentration sevoflurane in the treatment of hospitalized patients with bipolar disorder

A multicenter randomized controlled clinical trial for evaluation of efficacy and safety of adjunctive low-concentration sevoflurane in the treatment of hospitalized patients with bipolar disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029824
Enrollment
Unknown
Registered
2020-02-14
Start date
2020-02-24
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

bipolar disorder

Interventions

Experimental group :antipsychotics+sevoflurane
Control group 1:antipsychotics
Control group 2:antipsychotics+MECT

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients meeting the DSM-V, ICD-10 criteria for bipolar disorder; 2. Male or female patients aged 18-65 years; 3. Patients who are hospitalized (in-hospital patients) at screening phase remain in hospital during study period; 4. Do not change the dose of antipsychotics or use antipsychotics within one month, and do not use long-acting antipsychotic injections within six months; 5. Patients who are in the manic or mixed episode of bipolar disorder required to have a Young Mania Rating Scale (YMRS) total score of>= 18; and sevoflurane inhalation therapy was considered appropriate by the investigators; 6. Evidence of a subject (or a legal representative) signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study and are willing to participate in it.

Exclusion criteria

Exclusion criteria: 1. Manic or mixed episode due to delirium, schizophrenia, epilepsy, stunted growth, affective psychosis, poisoning, or substance abuse withdrawal response; 2. Relevent history or current presence of any cardiovascular, respiratory, neurological (Including apparent cerebrovascular disease), renal, hepatic, endocrine, immunologic or other systemic disease; 3. Clinically significant ECG abnormality; 4. Subjects with serum K+ or Mg2+ beyond the normal range; 5. A history of malignant syndrome or tardive dyskinesia history; 6. Pregnant or lactating women; 7. Monoamine oxidase antidepressants were administered prior to the study in 2 weeks; 8. Participation in other studies within the last 30 days before the current study begins and /or during study participation.

Design outcomes

Primary

MeasureTime frame
Young Mania Rating Scale;

Secondary

MeasureTime frame
CGI-BP;BPRS;BARS;PANSS;

Countries

China

Contacts

Public ContactXingrong Song

Guangzhou Women and Children's Medical Center

sxjess@126.com+86 13922416303

Outcome results

None listed

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