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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат Oxytocin nasal spray
  Syntocinon® nasal spray is applied according to description in arms section
• Другое Placebo
  Placebo nasal spray is applied according to description in arms section

Первичные конечные точки

• Personal and Social Performance Scale (PSP) [Срок оценки: from Visit 1 to Visit 4 i.e. 12 weeks]

Вторичные конечные точки (8)

• Positive and Negative Symptom Scale (PANSS) reduction [Срок оценки: from Visit 1 to Visit 4 i.e. 12 weeks]
• Clinical Global Impression-Schizophrenia scale (CGI-SCH) reduction [Срок оценки: from Visit 1 to Visit 4 i.e. 12 weeks]
• Global Assessment of Functioning (GAF) increase [Срок оценки: from Visit 1 to Visit 4 i.e. 12 weeks]
• Brief Psychiatric Rating Scale (BPRS) reduction [Срок оценки: from Visit 1 to Visit 4 i.e. 12 weeks]
• WHO Disability Assessment Schedule (WHODAS 2.0) increase [Срок оценки: from Visit 1 to Visit 4 i.e. 12 weeks]
• Personal and Social Performance Scale (PSP) [Срок оценки: from Visit 1 to Visit 4 i.e. 12 weeks]
• B-CATS improvement [Срок оценки: from Visit 1 to Visit 4 i.e. 12 weeks]
• Drop Out Rate [Срок оценки: from Visit 1 to Visit 4 i.e. 12 weeks]

Критерии участия

Критерии включения

• 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.

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Central Institute of Mental Health, Department of Psychiatry, — Mannheim

Идентификаторы

NCT: NCT06881810 · OXY-APS · 2023-509433-40-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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