OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia

Phase

N/A

Condition

Mood Disorders

Tourette's Syndrome

Psychosis

Treatment

Placebo

Oxytocin

Clinical Study ID

NCT06136390

401743

Ages 18-75
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 2weeks before study inclusion.

Exclusion

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 craniocerebraltrauma e.g. early childhood brain damage
Pregnancy and breastfeeding
Current electroconvulsive therapy If one of the following criteria applies to the participants, we will conduct an individualconsultation 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

Study Design

Placebo

September 30, 2023

December 30, 2024

Study Description

Schizophrenia spectrum disorders (SCZ) are severe mental illnesses with a lifetime prevalence of 1-2%. Three core syndromes characterize SCZ: positive and negative syndromes (NS), as well as a cognitive syndrome. The effectiveness of current treatment options for negative symptoms (NS) and sociocognitive deficits 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 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. 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, i.e. the difference in T7 - T0 of the negative syndrome subscale of the PANSS (Positive and Negative Syndrome Scale) after 4 weeks. The PANSS as a validated and structured clinical interview will be collected by a blinded psychiatrist. MBGT - sessions by experienced psychotherapists take place over four weeks. These sessions as a positive social context take place once a week in a group of about six patients. Participants received either synthetic oxytocin or a placebo 30 minutes before MBGT.

The role of genetic variations (OXTR genes) for the treatment effect on NS will be explored too as well as the effect on various stress markers including cortisol levels and the endocannabinoid system, affect, group cohesion and mindfulness.

The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.

Connect with a study center

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12203
Germany
Active - Recruiting

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