Schizophrenia Spectrum Disorders (SSD)Phase 2OXY-APSNCT06881810

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

A Phase 2 study testing Oxytocin nasal spray in people with Schizophrenia Spectrum Disorders (SSD), run by Central Institute of Mental Health, Mannheim at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Schizophrenia Spectrum Disorders (SSD)
What is being tested?: Oxytocin nasal spray
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 1 siteGermany
Study dates: 29 Aug 2024to 31 Mar 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Central Institute of Mental Health, Department of Psychiatry,
Mannheim, Baden-Wurttemberg, 68159

Other trials in Germany

About this study

Official title: 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)

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.

Conditions: Schizophrenia Spectrum Disorders (SSD)
Being tested: Oxytocin nasal spray, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxytocin nasal sprayDrug
Syntocinon® nasal spray is applied according to description in arms section
PlaceboOther
Placebo nasal spray is applied according to description in arms section

Study groups in NCT06881810
Study group	Role	What they receive
Oxytocin	Experimental	A single dose of 80 I.U. oxytocin in aerosol form (Syntocinon® nasal spray) is administered via 20 puffs 2 times per week intranasally. 1 ml of Syntocinon nasal spray contains 40 I.U. of oxytocin, with one puff equivalent to 0.1 ml of nasal spray (4 I.U. per spray). To reach the dose of 80 I.U. a total of ten spray puffs per nostril are required (1 ml per Nostril, 2 ml in total). The nasal spray is applied in a sitting position: * dose: 80 I.U. = 2 ml Syntocinon® nasal spray (cumulative total dose) is administered as intranasal spray twice a week, 45-75 min. before psychosocial intervention twice a week * duration of treatment: 12 weeks Receives: Drug: Oxytocin nasal spray
Placebo	Placebo comparator	* 2ml placebo dose is administered twice a week, 45-75 min. before psychosocial intervention twice a week * duration of treatment: 12 weeks Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Personal and Social Performance Scale (PSP)
The main purpose of this clinical trial is to evaluate the efficacy and safety of OXT combined with psychosocial interventions for improving social skills and psychopathology in SSD. We hypothesize a greater absolute PSP score improvement when OXT is administered together with the psychosocial intervention.
Measured: from Visit 1 to Visit 4 i.e. 12 weeks

Secondary outcomes (8)

Positive and Negative Symptom Scale (PANSS) reduction
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger PANSS total score reduction comparing V1 and V4 in the exploratory arm and a linear decrease of total PANSS score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Measured: from Visit 1 to Visit 4 i.e. 12 weeks
Clinical Global Impression-Schizophrenia scale (CGI-SCH) reduction
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger CGI-SCH reduction comparing V1 and V4 in the exploratory arm and a linear decrease of total CGI-SCH score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Measured: from Visit 1 to Visit 4 i.e. 12 weeks
Global Assessment of Functioning (GAF) increase
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger GAF increase comparing V1 and V4 in the exploratory arm and a linear increase of GAF total score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Measured: from Visit 1 to Visit 4 i.e. 12 weeks
Brief Psychiatric Rating Scale (BPRS) reduction
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger BPRS reduction in the exploratory arm and a linear decrease of total BPRS score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Measured: from Visit 1 to Visit 4 i.e. 12 weeks
WHO Disability Assessment Schedule (WHODAS 2.0) increase
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger increase in WHODAS 2.0 in the exploratory arm.
Measured: from Visit 1 to Visit 4 i.e. 12 weeks
Personal and Social Performance Scale (PSP)
Due to the expected enhanced social functioning in the OXT group we hypothesize a linear increase of total PSP score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Measured: from Visit 1 to Visit 4 i.e. 12 weeks
B-CATS improvement
We hypothesize a larger improvement across the cognitive domains in the relevant psychometric tests (B-CATS) in the exploratory over the course of the study.
Measured: from Visit 1 to Visit 4 i.e. 12 weeks
Drop Out Rate
We hypothesize a smaller likelihood of discontinuation in the OXT group.
Measured: from Visit 1 to Visit 4 i.e. 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Aug 202431 Mar 2028

First posted18 Mar 2025
Study start29 Aug 2024
Primary completion31 Mar 2028 (estimated)
Study completion31 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Schizophrenia Spectrum Disorders (SSD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: two-arm, double-blind, randomized
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06881810
Sponsor's protocol ID: OXY-APS
Other IDs: 2023-509433-40-00, 2023
Acronym: OXY-APS
Status last verified: Aug 2026
First submitted: 10 Mar 2025
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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