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A study of the effect of nasal spray oxytocin on social cognitive functioning in patients with chronic schizophrenia

A study of the effect of nasal spray oxytocin on social cognitive functioning in patients with chronic schizophrenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089996
Enrollment
Unknown
Registered
2024-09-23
Start date
2024-09-27
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Chronic schizophrenia

Interventions

Group A:A nasal spray of oxytocin 24 IU was given before breakfast (each nostril received three sprays) and the same dose of saline was given before dinner
for two consecutive weeks.
Group B:Saline 24 IU nasal spray was given before breakfast (each nostril received three sprays) and the same dose of oxytocin was given before dinner
Group C:A nasal spray of oxytocin 24 IU was given before breakfast and before dinner (each nostril received three sprays)
Control Group:Saline 24 IU nasal spray was given before breakfast and before dinner (each nostril received three sprays)
for a fortnight.

Sponsors

Huzhou Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: a. meet the DSM-5 diagnostic criteria for schizophrenia, the disease is in a stable phase, and the PANSS score is <60, with the following item scores =4 (e.g., P4, P6, P7, G2, G4, G8, and G14); b. be 18-45 years old and male; c. the subject is currently taking second-generation antipsychotics (=2) at a dose not exceeding the maximum dose specified in the instructions, and the The dose and frequency of administration were basically stable in the last 2 weeks; d. Literacy above junior high school; e. Han Chinese, right-handed; f. Able to understand the experimental instructions; g. Subjects or their guardians fully understood the purpose and requirements of this trial, voluntarily participated in the trial and signed a written informed consent form.

Exclusion criteria

Exclusion criteria: a. Patients who meet DSM-5 diagnostic criteria for other psychiatric disorders; b. Those with organic brain and serious physical illnesses and taking prescription or over-the-counter medications; c. Those with a history of coma from craniocerebral injuries; d. Those with previous seizures or a family history of epilepsy; e. Those with current infections, trauma, and concomitant immune disorders, or other medical illnesses; f. Those with a history of drug or substance abuse in the last 1 year or with a urine drug screen that is positive urine drug screen (except benzodiazepines); g. Smoking within the last 3 months, with an average of >10 cigarettes per day; h. Alcohol consumption within the last 6 months, with an average weekly alcohol intake of more than 14 units (1 unit is equal to 285 ml of beer or 25 ml of spirits or 150 ml of wine); i. Significant history of blood loss or =200 ml of blood loss in the last 3 months; j. Possible allergic reaction to any of the components of the drug; k. Possible hypersensitivity to any of the components of the drug; l. Positive urine drug screen; m. Positive urine drug screen; n. Positive urine drug screen. Allergy; k. Admission to or participation in other clinical trials within the last 3 months; l. Significant nasal mucosa and septum abnormalities; m. Contraindications to MRI; n. Mental retardation; o. Wechsler's Adult Intelligence Scale score of less than 86.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome Scale;CHINESE VERSION OF BRIEF NEUROCOGNITIVE TEST BATTERY;Chinese facial affective picture system;Metaphorical tasks;

Secondary

MeasureTime frame
Oxytocin (OXT) quantitative assay;

Countries

China

Contacts

Public ContactWang Hong

Huzhou Third People's Hospital

2412568940@qq.com+86 159 2563 2195

Outcome results

None listed

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