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) - OXY-APS

Zentralinstitut Fuer Seelische Gesundheit0 sites98 target enrollmentMarch 5, 2024

Conditionsschizophrenia or other primary psychotic disorders (SSD)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: schizophrenia or other primary psychotic disorders (SSD)
Sponsor: Zentralinstitut Fuer Seelische Gesundheit
Enrollment: 98
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 5, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Zentralinstitut Fuer Seelische Gesundheit

Eligibility Criteria

Inclusion 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 authority at screening. This includes: a. A woman who is not capable of bearing a child is defined as follows: post\-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea with serum\- FSH\-values (follicle\-stimulating hormone) of \>40 mIU/mL); 6 weeks after a bilateral ovariectomy with or without hysterectomy or sterilization by means of tubal ligation b. A woman capable of bearing child is defined as follows: a woman who is physiologically capable of becoming pregnant, including women whose occupation, lifestyle or sexual orientation exclude sexual intercourse with a male partner and women whose partners have been sterilized by vasectomy or other measures c. Medically\-approved methods of contraception can include the following: hormonal contraceptives, intrauterine device and double barrier method. Acceptable preventive measures can include total abstinence at the discretion of the investigator, in cases where compliance is ensured because of the study participant’s age, occupation, lifestyle or sexual orientation. Periodical abstinence (e.g. calendar, ovulation, symptothermal methods or abstinence until the 4th day after the ovulation) as well as coitus interruptus are not acceptable methods of contraception d. A reliable method of contraception (CTFG guideline) must be used for the entire duration of the study

Exclusion Criteria

•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 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 in another clinical trial (AMG/CTR) during and 4 weeks prior to inclusion.