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The study on the Efficacy and Safety of Ziprasidone Mesylate Injection in the Treatment of Acute Agitation Symptoms in Patients with Schizophrenia

The study on the Efficacy and Safety of Ziprasidone Mesylate Injection in the Treatment of Acute Agitation Symptoms in Patients with Schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100002
Enrollment
Unknown
Registered
2025-04-01
Start date
2023-01-10
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

schizophrenia

Interventions

Experimental group:IM Ziprasidone
Control group:IM Haloperidol

Sponsors

Shandong Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Inpatients who meet the diagnostic criteria for schizophrenia according to ICD-10, aged between 18 and 60 years, with no restrictions on gender; 2.PANSS-EC score = 15 points, with at least one item = 5 points; 3.ACE (Agitation-Calm Rating Scale) score = 3 points; 4.Approval from the Ethics Committee of Shandong Provincial Mental Health Center, and written informed consent obtained from the patient or their legal guardian.

Exclusion criteria

Exclusion criteria: 1. alcohol and/or substance abuse; 2.a previous diagnosis of another mental disease; 3. thyroid illness, gout, kidney disease, major organic brain disease, immune disease, diabetes, etc.; 4.an infection in the previous 4 weeks or use of anti-inflammatory drugs, antibiotics, or glucocorticoids; 5. breastfeeding or pregnant; 6. regular use of psychiatric drugs in the past 2 weeks; 7. validated clinical significant abnormal laboratory values; 8.QTc prolongation or a prodrug QTc over or equal to 450 milliseconds; 9.known allergy to ziprasidone or haloperidol; 10.those who were treated with electroconvulsive therapy during the previous 4 weeks.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome Scale;Excitement Factor of Positive and Negative Syndrome Scale;

Secondary

MeasureTime frame
Agitation-Calm Rating Scale;Behavioral Activity Rating Scale;Electrocardiogram;Blood Routine Examination;C-reactive protein;

Countries

China

Contacts

Public ContactQi Sufang

Shandong Mental Health Center

sufqi2022@163.com+86 151 5413 5030

Outcome results

None listed

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