RecruitingPhase 2NCT06881810

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

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)

Sponsor

Central Institute of Mental Health, Mannheim

Enrollment

98 participants

Start Date

Aug 29, 2024

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Spectrum Disorders (SSD)

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.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria7

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.

Exclusion Criteria8

Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)
Coercive treatment at the time of study inclusion
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).
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