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)

Phase 1

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

Registration Number: CTIS2023-509433-40-00

Lead Sponsor: Zentralinstitut Fuer Seelische Gesundheit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 98

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of intranasal oxytocin compared to placebo as an add-on to psychosocial treatment (TAU) of schizophrenia spectrum disorders.;Secondary Objective: To evaluate improvements in psychopathology, social and occupational functioning., To analyze changes in neurocognition., To compare changes in cumulative dose of concomitant and rescue medication.;Primary end point(s): Change of Personal and Social Performance Scale (PSP) after 12 weeks (V1-V4)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Improvement in psychopathology from baseline (PANSS, BPRS, CGI-SCH), social and occupational functioning (GAF) and quality of life (WHODAS 2.0, The Oxford Positive Self Scale ).;Secondary end point(s):Changes from baseline in the Calgary Depression Scale for Schizophrenia (CDSS).;Secondary end point(s):Changes from baseline in Neurocognition (B-CATS).;Secondary end point(s):all-cause discontinuation;Secondary end point(s):EMA (ecological momentary assessment) and passive sensing;Secondary end point(s):Drug Attitude Inventory (DAI) and self-reported treatment adherence.;Secondary end point(s):cumulative dose of concomitant or rescue medication.;Secondary end point(s):Genetic alterations in the oxytocin receptor gene;Secondary end point(s):Changes of biomarkers: alteration in brain networks, DNAmethylation, Oxytocin in blood and saliva.;Secondary end point(s):Measurement of real-life social contacts;Secondary end point(s):Measurement of physical activity