Could a 'Love Hormone' nasal spray help people with schizophrenia connect better?
NCT ID NCT06881810
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding oxytocin nasal spray to standard psychosocial treatment can improve social skills and reduce symptoms in adults with schizophrenia spectrum disorders. Participants receive either oxytocin or a placebo spray alongside their usual therapy. The study measures changes in social performance and symptom severity to see if oxytocin offers an extra benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Oxytocin nasal spray (Syntocinon) as an add-on to individualized psychosocial treatment
- What this could lead to
- If effective, this could offer a new way to improve social functioning and reduce symptoms in people with schizophrenia spectrum disorders.
- What could go wrong
- This is an early-phase trial with a modest number of participants, so results may not be conclusive or generalizable. Oxytocin may not outperform placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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98 people
The number who actually took part.
- Started
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Aug 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. 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. Exclusion Criteria: 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Central Institute of Mental Health, Department of Psychiatry,
Mannheim, Baden-Wurttemberg, 68159, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.