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.
Trial summary
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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dusan Hirjak, Prof. Dr., Principal investigator, Central Institute of Mental Health
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06881810
- Acronym / sponsor ID
- OXY-APS / OXY-APS
- Conditions
- Schizophrenia Spectrum Disorders (SSD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two-arm, double-blind, randomized
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin nasal sprayA 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 |
| Placebo | Placebo comparator | Other: Placebo* 2ml placebo dose is administered twice a week, 45-75 min. before psychosocial intervention twice a week * duration of treatment: 12 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal spraySyntocinon® nasal spray is applied according to description in arms section | Drug | Oxytocin |
| PlaceboPlacebo nasal spray is applied according to description in arms section | Other | Placebo |
Primary outcome
Personal and Social Performance Scale (PSP)
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
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.
8 secondary outcomes
Positive and Negative Symptom Scale (PANSS) reduction
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
Clinical Global Impression-Schizophrenia scale (CGI-SCH) reduction
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
Global Assessment of Functioning (GAF) increase
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
Brief Psychiatric Rating Scale (BPRS) reduction
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
WHO Disability Assessment Schedule (WHODAS 2.0) increase
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
Personal and Social Performance Scale (PSP)
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
B-CATS improvement
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
Drop Out Rate
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dusan Hirjak, Prof. Dr. principal investigator
Central Institute of Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal and Social Performance Scale (PSP) (time frame: from Visit 1 to Visit 4 i.e. 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.