NCT07265180 Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison
| NCT ID | NCT07265180 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Schizophrenia Spectrum Disorders (SSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-09-08 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-09-08 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The effectiveness of current treatment options for sociocognitive deficits and negative symptoms (NS) in schizophrenia spectrum disorders (SSD) remains limited. The cause of NS is thought to be an interference between the mesocorticolimbic dopamine system for social reward expectancy and the network for socioemotional processes. Oxytocin (OXT) may enhance functional connectivity between these neuronal networks. Lower plasma OXT levels correlate negatively with NS severity and deficits in social cognition in SSD. It has been shown that intranasal OXT administration improves social cognition in healthy subjects but in SSD results are inconsistent. According to the social salience hypothesis, the effect of OXT varies depending on the social context and individual factors. Also, OXT-mediated effects on psychopathology and NS may depend on genetic variants of OXT receptors (OXTR). In a pilot study, the investigators demonstrated lower NS by OXT administration in a positive social context of mindfulness-based group psychotherapy (MBGT) in SSD. The investigators also demonstrated that symptoms improved after MBGT. A more recent study suggests that, compared to placebo, administering OXT in a positive social context via MBGT leads to significant between-group differences favoring OXT, particularly in NS, affect, and stress. Building on these findings, the present study investigates the stability of these effects, along with psychological and biological markers, in a larger sample of individuals with SSD. The main hypothesis to be tested is that the use of OXT compared to placebo prior to MBGT in patients with SSD will result in a greater reduction in NS with a higher OXT dosage. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.
Eligibility Criteria
Inclusion Criteria: * Declaration of consent * Psychiatric diagnosis of schizophrenia (ICD-10: F2x.x spectrum) for group of patients * Mild to moderate positive symptoms (5 ≤ Positive symptoms on individual items using P-PANSS) * German should either be the native language or spoken at a native level * No change in systematically recorded psychopharmacological medication in the last 2 weeks before study inclusion Exclusion Criteria: * Acute psychotic episode with severe positive symptoms (ICD-10: F2 spectrum, 6 ≥ positive symptoms on individual items using P-PANSS) * Acute suicidality * Acute consumption phase of a substance dependence, except nicotine * No severe physical impairments, neurological diseases and e.g. severe craniocerebral trauma e.g. early childhood brain damage * Pregnancy and breastfeeding * Current acute electroconvulsive therapy If one of the following criteria applies to the participants, we will conduct an individual consultation in advance to determine whether participation in the study is possible: * Overweight or underweight (body mass index (BMI) \< 17.5 or \> 30) * Disease of the endocrine system * Impaired kidney or liver function * Metabolic diseases * Asthma * Change in blood potassium or sodium levels
Contact & Investigator
Marco Zierhut, MD
PRINCIPAL INVESTIGATOR
Charite University, Berlin, Germany
Frequently Asked Questions
Who can join the NCT07265180 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Schizophrenia Spectrum Disorders (SSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07265180 currently recruiting?
Yes, NCT07265180 is actively recruiting participants. Contact the research team at marco.zierhut@charite.de for enrollment information.
Where is the NCT07265180 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07265180 clinical trial?
NCT07265180 is sponsored by Charite University, Berlin, Germany. The principal investigator is Marco Zierhut, MD at Charite University, Berlin, Germany. The trial plans to enroll 120 participants.
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