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A comparative study of olanzapine oral solution film, ziprasidone mesylate for injection and haloperidol injection in the treatment of acute agitation symptoms of schizophrenia

A comparative study of olanzapine oral solution film, ziprasidone mesylate for injection and haloperidol injection in the treatment of acute agitation symptoms of schizophrenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063052
Enrollment
Unknown
Registered
2022-08-29
Start date
2022-08-30
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Schizophrenia

Interventions

Group 1 :Olanzapine oral dissolution film
Group 2:ziprasidone injection
Group 3:haloperidol injection

Sponsors

The Third Hospital of Fuyang
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18-60 years old, regardless of gender. 2. Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for schizophrenia; 3. There are agitation symptoms; 4. Primary school or above; 5. Understand the content of the study, be willing to participate in this study, and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Suffering from other severe mental disorders that meet the DSM-5 diagnostic criteria, including organic mental disorders, alcohol dependence, drug dependence/abuse, depression, bipolar disorder, etc.; 2. Hypertensive patients with poor blood pressure control (SBP >= 140 mmHg or DBP >= 90 mmHg at screening and baseline visit); 3. Unable to provide informed consent; 4. Women who are pregnant or breastfeeding; 5. Positive urine toxicology screening at screening or at baseline; 6. Those with previous organic brain lesions or severe brain trauma; 7. Patients with severe heart, liver and kidney insufficiency, metabolic diseases and other serious physical diseases; 8. Clinically significant electrocardiogram (ECG) abnormalities at the time of screening, including sinus bradycardia (resting heart rate = 450 ms, women >= 470 ms), history of congenital long QT syndrome, or risk of torsades de pointes due to family history of sudden death, etc.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Symptom Scale;General Impression of Clinical Outcome Scale;Episodic Aggressive Behavior Scale, Extrapyramidal Parasympathetic Reaction Scale;UKU Side Effects Scale;

Countries

China

Contacts

Public ContactShu Cui

The Third Hospital of Fuyang

119887822@qq.com+86 13965565222

Outcome results

None listed

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