OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia

NCT ID: NCT06136390

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-12-30

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 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.

Detailed 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.

Conditions

Schizophrenia Spectrum Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oxytocin

The patients received a spray of the 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 mins after intranasal administration of oxytocin on social behavior, the dose was administered 45 min before the 50-min session.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: OTHER

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

Placebo

The patients received a spray of placebo (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 mins after intranasal administration of oxytocin on social behavior, the dose was administered 45 min before the 50-min session.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Oxytocin

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

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Kerem Böge

PD Dr. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Zierhut, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Kerem Böge, PD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Eric Hahn, PD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, State of Berlin, Germany

Countries

Germany

References

Boge K, Hahne I, Bergmann N, Wingenfeld K, Zierhut M, Thomas N, Ta TMT, Bajbouj M, Hahn E. Mindfulness-based group therapy for in-patients with schizophrenia spectrum disorders - Feasibility, acceptability, and preliminary outcomes of a rater-blinded randomized controlled trial. Schizophr Res. 2021 Feb;228:134-144. doi: 10.1016/j.schres.2020.12.008. Epub 2021 Jan 9.

Reference Type: RESULT

PMID: 33434727 (View on PubMed)

Other Identifiers

401743

Identifier Type: -

Identifier Source: org_study_id