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New treatment option for Schizophrenia Spectrum Disorders (SSD)
Official title Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment
ClinicalTrials.gov ID: NCT06881810
What this study is testing
What is Oxytocin nasal spray?
Oxytocin nasal spray is an investigational medicine, being studied as a potential treatment for schizophrenia spectrum disorders (ssd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join 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
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mannheim, Baden-Wurttemberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mannheim, Baden-Wurttemberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.