OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia

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 a lower NS by OXT administration in the positive social context of MBGT in SSD. The investigators also demonstrated that NS and other symptoms improved after mindfulness-based group psychotherapy (MBGT). The aim of this study in individuals with SSD is to examine the effect of combining OXT administration with MBGT on NS, affect, and stress with psychological and biological markers. 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. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.

Conditions

• Schizophrenia Spectrum Disorders

Interventions

OTHER

Oxytocin

Oxytocin nasal spray in combination with mindfulness based group therapy (MBGT).

OTHER

Placebo

Placebo nasal spray in combination with mindfulness based group therapy (MBGT).

Sponsors & Collaborators

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Marco Zierhut, MD · Charite University, Berlin, Germany

• Kerem Böge, PD · Charite University, Berlin, Germany

• Eric Hahn, PD · Charite University, Berlin, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-30

Primary Completion

2024-12-30

Completion

2024-12-30

Countries

• Germany

Study Locations