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Effect and safety of dexmedetomidine nasal spray in controlling agitation symptoms in patients with mental disorders

Effect and safety of dexmedetomidine nasal spray in controlling agitation symptoms in patients with mental disorders

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102821
Enrollment
Unknown
Registered
2025-05-20
Start date
2024-12-26
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Patients with mental disorders in acute phase

Interventions

Control subjects:Haloperidol intramuscular injection

Sponsors

Shandong Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old; 2. Meet the diagnostic criteria for schizophrenia, bipolar disorder, dissociative [conversion] disorder, and depressive disorder (F20, F31-F33, F44) in the 10th edition of the International Classification of Diseases (ICD-10); 3. Behavioral Activity Rating Scale (BARS) scores of >4; 4. Signed informed consent by the patient or guardian.

Exclusion criteria

Exclusion criteria: 1. those with other serious neuropsychiatric disorders in combination; 2. those with previous or current serious and unstable physical illnesses; 3. those who are unable to cooperate in completing the relevant assessments as required; 4. those who are currently involved in other clinical studies.

Design outcomes

Primary

MeasureTime frame
blood biochemistry;positive and negative syndrome scale-excited component subscale, PANSS-EC;behavioural activity rating scale,BARS;modified overt aggression scale,MOAS;Clinical Global Impression Scale, CGI;

Secondary

MeasureTime frame
routine blood test;CRP;ECG;Self-made adverse event (AE) registry form;Brief Mental State Scale, MMSE;

Countries

China

Contacts

Public ContactXu Chen

Shandong Mental Health Center

ch99jn@163.com+86 187 0531 7127

Outcome results

None listed

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