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Efficacy and safety of adjunctive low-concentration sevoflurane for the treatment of hospitalized acute schizophrenia: a multicenter, randomized, active-controlled clinical trial.

Efficacy and safety of adjunctive low-concentration sevoflurane for the treatment of hospitalized acute schizophrenia: a multicenter, randomized, active-controlled clinical trial.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027767
Enrollment
Unknown
Registered
2019-11-28
Start date
2019-12-01
Completion date
Unknown
Last updated
2020-04-20

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

Conditions

schizophrenia

Interventions

Experimental group:antipsychotics (Risperidone/Paliperidone/Olanzapine) and Sevoflurane
Control group:antipsychotics (Risperidone/Paliperidone/Olanzapine)

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Subjects meeting with the DSM-5 criteria for diagnose of schizophrenia, the course of disease within 5 years; 2. Male or female, aged 18-50 years; 3. Subjects who are hospitalized (in-hospital patients) at screening phase, and can remain in hospital during study perious; 4. Subjects who are in the phrase of acute schizophrenia with a score from 70 to 120 on the PANSS scale and are appropriate to receive sevoflurane inhalation according to the investigators judgment; 5. Subjects with a minimum score of 14 on the PANSS -excited component (PANSS-EC) and at least 1 item no less than 4 (P4. excited, P7. Hostility, G4. Physical tension, G8. Uncooperative, G14. Impulse control disorder); 6.No long-term antipsychotic injection within 6 months; 7. An informed consent with the subject's signature (or legally acceptable representative) and the date of signature indicating that the subject (or a legally acceptable representative) has been informed of all information relating to the study and are willing to participate in the study; 8. No systemic antipsychotics use in 2 weeks prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Acute phrase due to delirium, seizures, affective psychosis, poisoning, or substance abuse withdrawal reactions; 2. Relevent history or current presence of any major or unstable cardiovascular, respiratory, neurological, renal, hepatic, endocrine, immunologic or other systemic disease; 3. Confirmed clinically significant abnormal laboratory values; 4. Clinically significant ECG abnormality; 5. Subjects with a history of QTc prolongation or QTc of 450 msec or greater before drug adiministration; 6. Subjects with serum K+ or Mg2+ beyond the normal range; 7. A history of malignant syndrome or tardive dyskinesia history; 8. Pregnant or lactating women; 9. Monoamine oxidase antidepressants were administered prior to the study in 2 weeks; 10. Long-acting antipsychotics were administered prior to screening in 6 months; 11. Participation in other studies within the last 30 days before the current study begins and /or during study participation.

Design outcomes

Primary

MeasureTime frame
PANSS;

Secondary

MeasureTime frame
BPRS;TESS;MCCB;CGI-I;CGI-S;AMS;PANSS-EC;PSP;AEs;MAC;weight;hemodynamic parameters;

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