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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Zentralinstitut Fuer Seelische Gesundheit

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

29 Aug 2024 → ongoing

Decision date (initial)

2024-05-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of intranasal oxytocin compared to placebo as an add-on to psychosocial treatment (TAU) of schizophrenia spectrum disorders.

Secondary objectives 3

1. To evaluate improvements in psychopathology, social and occupational functioning.
2. To analyze changes in neurocognition.
3. To compare changes in cumulative dose of concomitant and rescue medication.

Conditions and MedDRA coding

schizophrenia or other primary psychotic disorders (SSD)

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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. 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 8

1. Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)
2. Coercive treatment at the time of study inclusion
3. 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).
4. Documented intolerance to the study drug or any of its ingredients.
5. Pregnancy (incl. positive urine or blood pregnancy test) / breastfeeding (female patients) or lactating individuals
6. Severe endocrinological disorder besides diabetes
7. Endometriosis
8. Concurrent participation in another clinical trial (AMG/CTR) during and 4 weeks prior to inclusion.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change of Personal and Social Performance Scale (PSP) after 12 weeks (V1-V4)

Secondary endpoints 11

1. 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 ).
2. Changes from baseline in the Calgary Depression Scale for Schizophrenia (CDSS).
3. Changes from baseline in Neurocognition (B-CATS).
4. all-cause discontinuation
5. EMA (ecological momentary assessment) and passive sensing
6. Drug Attitude Inventory (DAI) and self-reported treatment adherence.
7. cumulative dose of concomitant or rescue medication.
8. Genetic alterations in the oxytocin receptor gene
9. Changes of biomarkers: alteration in brain networks, DNAmethylation, Oxytocin in blood and saliva.
10. Measurement of real-life social contacts
11. Measurement of physical activity

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Zentralinstitut Fuer Seelische Gesundheit

Sponsor organisation

Zentralinstitut Fuer Seelische Gesundheit

Address

Luisenring J 5

City

Mannheim

Postcode

68159

Country

Germany

Scientific contact point

Organisation

Zentralinstitut Fuer Seelische Gesundheit

Contact name

Prof. Dr. Dusan Hirjak

Public contact point

Organisation

Zentralinstitut Fuer Seelische Gesundheit

Contact name

Prof. Dr. Dusan Hirjak

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications