Oxytocin-Augmented Mindfulness-Based Group Psychotherapy for Patients With Schizophrenia Spectrum Disorders - an Oxytocin-dose Comparison (OXYMIND2.0)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Campus Charité Mitte
RECRUITING
Berlin
Contact Information
Primary
Marco Zierhut, MD
marco.zierhut@charite.de
004930450517547
Backup
Kerem Böge, Prof.
kerem.boege@charite.de
004930450517789
Time Frame
Start Date: 2025-09-08
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 120
Treatments
Active_comparator: Oxytocin (24 I.U. Syntocinon®)
The patients received a spray of synthetic oxytocin (24 I.U. Syntocinon®) in combination with mindfulness-based group therapy (MBGT) over 4 weeks once a week. Due to an effect latency of 30-80 min after intranasal administration of oxytocin on social behavior, the dose was administered 30 min before the 50 min session.
Active_comparator: Oxytocin (48 I.U. Syntocinon®)
The patients received a spray of synthetic oxytocin (48 I.U. Syntocinon®) in combination with mindfulness-based group therapy (MBGT) over 4 weeks once a week. Due to an effect latency of 30-80 min after intranasal administration of oxytocin on social behavior, the dose was administered 30 min before the 50 min session.
Placebo_comparator: Placebo
The patients received a placebo nasal spray in combination with mindfulness-based group therapy (MBGT) over 4 weeks once a week. Due to an effect latency of 30-80 min after intranasal administration of oxytocin on social behavior, the dose was administered 30 min before the 50 min session.
Related Therapeutic Areas
Sponsors
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov