Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment

NCT06881810 | Recruiting Phase 2

• 2 other identifiers: OXY-APS2023-509433-40-00
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Research on schizophrenia spectrum disorders (SSD) patients with social impairment is essential for improving treatment, enhancing the lives of affected individuals, reducing stigma, and advancing our understanding of this complex psychiatric disorder. A clinical trial focusing on the improvement of social skills in SSD has the potential to transform clinical practice and support systems to better meet the needs of those living with SSD. Because of the role of oxytocin in regulating social behaviors and emotions, the investigator hypothesizes that it is beneficial in addressing the social cognition deficits observed in SSD when combined with psychosocial interventions.

Conditions

Schizophrenia Spectrum Disorders (SSD)

Outcome Measures

Primary Outcomes (1)

• Personal and Social Performance Scale (PSP)

  The main purpose of this clinical trial is to evaluate the efficacy and safety of OXT combined with psychosocial interventions for improving social skills and psychopathology in SSD. We hypothesize a greater absolute PSP score improvement when OXT is administered together with the psychosocial intervention.

  from Visit 1 to Visit 4 i.e. 12 weeks

Secondary Outcomes (8)

• Positive and Negative Symptom Scale (PANSS) reduction

  from Visit 1 to Visit 4 i.e. 12 weeks

• Clinical Global Impression-Schizophrenia scale (CGI-SCH) reduction

  from Visit 1 to Visit 4 i.e. 12 weeks

• Global Assessment of Functioning (GAF) increase

  from Visit 1 to Visit 4 i.e. 12 weeks

• Brief Psychiatric Rating Scale (BPRS) reduction

  from Visit 1 to Visit 4 i.e. 12 weeks

• WHO Disability Assessment Schedule (WHODAS 2.0) increase

  from Visit 1 to Visit 4 i.e. 12 weeks

Study Arms (2)

Oxytocin

EXPERIMENTAL

A single dose of 80 I.U. oxytocin in aerosol form (Syntocinon® nasal spray) is administered via 20 puffs 2 times per week intranasally. 1 ml of Syntocinon nasal spray contains 40 I.U. of oxytocin, with one puff equivalent to 0.1 ml of nasal spray (4 I.U. per spray). To reach the dose of 80 I.U. a total of ten spray puffs per nostril are required (1 ml per Nostril, 2 ml in total). The nasal spray is applied in a sitting position: * dose: 80 I.U. = 2 ml Syntocinon® nasal spray (cumulative total dose) is administered as intranasal spray twice a week, 45-75 min. before psychosocial intervention twice a week * duration of treatment: 12 weeks

Drug: Oxytocin nasal spray

Placebo

PLACEBO COMPARATOR

* 2ml placebo dose is administered twice a week, 45-75 min. before psychosocial intervention twice a week * duration of treatment: 12 weeks

Other: Placebo

Interventions

Oxytocin nasal spray DRUG

Syntocinon® nasal spray is applied according to description in arms section

Oxytocin

Placebo OTHER

Placebo nasal spray is applied according to description in arms section

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 64 years
• Written informed consent (must be available before enrolment in the clinical trial)
• ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview
• At least one symptom of moderate severity or worse in the PANSS negative subscale (a score ≥ 4 for one or more symptoms from N1-N7 at baseline).
• In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study
• Male participants and female participants who are not capable of bearing children or female patients of childbearing potential who use a highly effective birth control method that is medically approved by the health authority at screening.
• \. Age 18 to 64 years 2. Written informed consent (must be available before enrolment in the clinical trial) 3. ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview 4. At least one symptom of moderate severity or worse in the PANSS negative subscale (a score ≥ 4 for one or more symptoms from N1-N7 at baseline). 5. In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study 6. Male participants and female participants who are not capable of bearing children or female patients of childbearing potential who use a highly effective birth control method that is medically approved by the health authority at screening.

You may not qualify if:

• Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)
• Documented intolerance to the study drug or any of its ingredients.
• Pregnancy (incl. positive urine or blood pregnancy test) / breastfeeding (female patients) or lactating individuals
• Severe endocrinological disorder besides diabetes
• Endometriosis
• Concurrent participation

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, 68159, Germany

RECRUITING

Study Officials

• Dusan Hirjak, Prof. Dr.

  Central Institute of Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dusan Hirjak, Prof. Dr.

CONTACT

0621 1703; dusan.hirjak@zi-mannheim.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-arm, double-blind, randomized

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 18, 2025
• Study Start: August 29, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

DE (1)