NCT06881810 Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment
| NCT ID | NCT06881810 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Central Institute of Mental Health, Mannheim |
| Condition | Schizophrenia Spectrum Disorders (SSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2024-08-29 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 98 participants in total. It began in 2024-08-29 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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. 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. 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
Contact & Investigator
Dusan Hirjak, Prof. Dr.
PRINCIPAL INVESTIGATOR
Central Institute of Mental Health
Frequently Asked Questions
Who can join the NCT06881810 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Schizophrenia Spectrum Disorders (SSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06881810 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06881810 currently recruiting?
Yes, NCT06881810 is actively recruiting participants. Contact the research team at dusan.hirjak@zi-mannheim.de for enrollment information.
Where is the NCT06881810 trial being conducted?
This trial is being conducted at Mannheim, Germany.
Who is sponsoring the NCT06881810 clinical trial?
NCT06881810 is sponsored by Central Institute of Mental Health, Mannheim. The principal investigator is Dusan Hirjak, Prof. Dr. at Central Institute of Mental Health. The trial plans to enroll 98 participants.
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