Enhancing social skills in schizophrenia spectrum disorders – two-arm, double-blind, randomized clinical trial investigating oxytocin vs. placebo as an add-on to an individualized psychosocial treatment (OXY-APS)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509433-40-00

Acronym

OXY-APS

Enrollment

Registered

2024-05-16

Start date

2024-08-29

Completion date

Unknown

Last updated

2025-02-26

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

Conditions

schizophrenia or other primary psychotic disorders (SSD)

Brief summary

Change of Personal and Social Performance Scale (PSP) after 12 weeks (V1-V4)

Detailed description

Improvement in psychopathology from baseline (PANSS, BPRS, CGI-SCH), social and occupational functioning (GAF) and quality of life (WHODAS 2.0, The Oxford Positive Self Scale )., Changes from baseline in the Calgary Depression Scale for Schizophrenia (CDSS)., Changes from baseline in Neurocognition (B-CATS)., all-cause discontinuation, EMA (ecological momentary assessment) and passive sensing, Drug Attitude Inventory (DAI) and self-reported treatment adherence., cumulative dose of concomitant or rescue medication., Genetic alterations in the oxytocin receptor gene, Changes of biomarkers: alteration in brain networks, DNAmethylation, Oxytocin in blood and saliva., Measurement of real-life social contacts, Measurement of physical activity

Interventions

DRUGSYNTOCINON 40 i.e./ml pršilo za nos

DRUGraztopina

DRUGOxytocin Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change of Personal and Social Performance Scale (PSP) after 12 weeks (V1-V4)	—

Secondary

Measure	Time frame
Improvement in psychopathology from baseline (PANSS, BPRS, CGI-SCH), social and occupational functioning (GAF) and quality of life (WHODAS 2.0, The Oxford Positive Self Scale )., Changes from baseline in the Calgary Depression Scale for Schizophrenia (CDSS)., Changes from baseline in Neurocognition (B-CATS)., all-cause discontinuation, EMA (ecological momentary assessment) and passive sensing, Drug Attitude Inventory (DAI) and self-reported treatment adherence., cumulative dose of concomitant or rescue medication., Genetic alterations in the oxytocin receptor gene, Changes of biomarkers: alteration in brain networks, DNAmethylation, Oxytocin in blood and saliva., Measurement of real-life social contacts, Measurement of physical activity	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026