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Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison

RecruitingNAAges 18 Years - 75 YearsAllCharite University, Berlin, Germany
NCT07265180 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Oxytocin
  • Placebo
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Where

1 site
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Campus Charité Mitte
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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