OXYTOCIN for Schizophrenia spectrum disorders

Inclusion criteria

• {"criterion_text":"- Age 18 to 64 years\n- Written informed consent (must be available before enrolment in the clinical trial)\n- ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview\n- 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).\n- In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study\n- 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

• {"criterion_text":"- Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)\n- Coercive treatment at the time of study inclusion\n- 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).\n- Documented intolerance to the study drug or any of its ingredients.\n- Pregnancy (incl. positive urine or blood pregnancy test) / breastfeeding (female patients) or lactating individuals\n- Severe endocrinological disorder besides diabetes\n- Endometriosis\n- Concurrent participation in another clinical trial (AMG/CTR) during and 4 weeks prior to inclusion."}

Primary endpoints

• {"endpoint_text":"- Change of Personal and Social Performance Scale (PSP) after 12 weeks (V1-V4)","definition_or_measurement_approach":"Change in PSP score from baseline to 12 weeks (assessed at visits V1–V4)."}

Secondary endpoints

• {"endpoint_text":"- 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 ).","definition_or_measurement_approach":"Change from baseline measured using PANSS, BPRS, CGI-SCH for psychopathology; GAF for social/occupational functioning; WHODAS 2.0 and The Oxford Positive Self Scale for quality of life."}
• {"endpoint_text":"- Changes from baseline in the Calgary Depression Scale for Schizophrenia (CDSS).","definition_or_measurement_approach":"Change from baseline in CDSS score."}
• {"endpoint_text":"- Changes from baseline in Neurocognition (B-CATS).","definition_or_measurement_approach":"Change from baseline in B-CATS neurocognitive battery scores."}
• {"endpoint_text":"- all-cause discontinuation","definition_or_measurement_approach":"Proportion and reasons for discontinuation from study for any cause."}
• {"endpoint_text":"- EMA (ecological momentary assessment) and passive sensing","definition_or_measurement_approach":"Assessment via ecological momentary assessment tools and passive sensing devices to capture behavior and context over time."}
• {"endpoint_text":"- Drug Attitude Inventory (DAI) and self-reported treatment adherence.","definition_or_measurement_approach":"DAI questionnaire scores and self-reported adherence measures."}
• {"endpoint_text":"- cumulative dose of concomitant or rescue medication.","definition_or_measurement_approach":"Calculated cumulative dose of concomitant and rescue medications over the study period."}
• {"endpoint_text":"- Genetic alterations in the oxytocin receptor gene","definition_or_measurement_approach":"Genetic analysis/genotyping for alterations in the OXTR gene."}
• {"endpoint_text":"- Changes of biomarkers: alteration in brain networks, DNAmethylation, Oxytocin in blood and saliva.","definition_or_measurement_approach":"Biomarker measurements including imaging/network analyses, DNA methylation assays, and oxytocin concentration assays in blood and saliva."}
• {"endpoint_text":"- Measurement of real-life social contacts","definition_or_measurement_approach":"Assessment of real-life social contacts via questionnaires, EMA, or passive sensing as specified in study methods."}
• {"endpoint_text":"- Measurement of physical activity","definition_or_measurement_approach":"Assessment of physical activity via objective sensors or self-report measures."}

Germany

Earliest CTIS Part Ii Submission Date

21-03-2024

Latest Decision Or Authorization Date

26-02-2025

Processing Time Days

342

Number Of Sites

1

Number Of Participants

98

Primary sponsor

Full Name

Zentralinstitut Fuer Seelische Gesundheit

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany