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

Phase 2

Recruiting

• Conditions: Schizophrenia Spectrum Disorders (SSD)
• Interventions: Drug: Oxytocin nasal spray; Other: Placebo

• Registration Number: NCT06881810
• Lead Sponsor: Central Institute of Mental Health, Mannheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-29
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-18
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. 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.

7. 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.

Exclusion Criteria

1. Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)
2. Coercive treatment at the time of study inclusion
3. Diagnosis of primary substance dependency other than nicotine: exclusion alcohol dependency via AUDIT-screening (Bohn, Babor et al. 1995; Babor et al. 2001) and ICD- 11 criteria (MINI-DIPS-OA); exclusion of other drug dependencies other than alcohol and nicotine: drug screening of urine and ICD-11 criteria (MINI-interview: patient fulfilling early (> 3 months) or sustained (>12 months) remission criteria and/or with low severity of substance use disorder according to MINI (ICD-11) are eligible for the study).
4. Documented intolerance to the study drug or any of its ingredients.
5. Pregnancy (incl. positive urine or blood pregnancy test) / breastfeeding (female patients) or lactating individuals
6. Severe endocrinological disorder besides diabetes
7. Endometriosis
8. Concurrent participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin	Oxytocin nasal spray	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
Placebo	Placebo	* 2ml placebo dose is administered twice a week, 45-75 min. before psychosocial intervention twice a week * duration of treatment: 12 weeks

Primary Outcome Measures

Name	Time	Method
Personal and Social Performance Scale (PSP)	from Visit 1 to Visit 4 i.e. 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Symptom Scale (PANSS) reduction	from Visit 1 to Visit 4 i.e. 12 weeks	Due to the expected enhanced social functioning in the OXT group we hypothesize a larger PANSS total score reduction comparing V1 and V4 in the exploratory arm and a linear decrease of total PANSS score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Clinical Global Impression-Schizophrenia scale (CGI-SCH) reduction	from Visit 1 to Visit 4 i.e. 12 weeks	Due to the expected enhanced social functioning in the OXT group we hypothesize a larger CGI-SCH reduction comparing V1 and V4 in the exploratory arm and a linear decrease of total CGI-SCH score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Global Assessment of Functioning (GAF) increase	from Visit 1 to Visit 4 i.e. 12 weeks	Due to the expected enhanced social functioning in the OXT group we hypothesize a larger GAF increase comparing V1 and V4 in the exploratory arm and a linear increase of GAF total score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Brief Psychiatric Rating Scale (BPRS) reduction	from Visit 1 to Visit 4 i.e. 12 weeks	Due to the expected enhanced social functioning in the OXT group we hypothesize a larger BPRS reduction in the exploratory arm and a linear decrease of total BPRS score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
WHO Disability Assessment Schedule (WHODAS 2.0) increase	from Visit 1 to Visit 4 i.e. 12 weeks	Due to the expected enhanced social functioning in the OXT group we hypothesize a larger increase in WHODAS 2.0 in the exploratory arm.
Personal and Social Performance Scale (PSP)	from Visit 1 to Visit 4 i.e. 12 weeks	Due to the expected enhanced social functioning in the OXT group we hypothesize a linear increase of total PSP score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
B-CATS improvement	from Visit 1 to Visit 4 i.e. 12 weeks	We hypothesize a larger improvement across the cognitive domains in the relevant psychometric tests (B-CATS) in the exploratory over the course of the study.
Drop Out Rate	from Visit 1 to Visit 4 i.e. 12 weeks	We hypothesize a smaller likelihood of discontinuation in the OXT group.

Trial Locations

Locations (1)

Central Institute of Mental Health, Department of Psychiatry,; 🇩🇪 Mannheim, BW, Germany