OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia

NCT06136390 | Completed

• 1 other identifier: 401743
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• Change in PANSS Negative Symptoms

  The Positive and Negative Syndrome Scale (PANSS) is one of the most widely used rater instruments for the assessment of the presence and severity of psychotic symptoms. Each scale comprises seven statements which are rated by the interviewer using a seven-point Likert format (from 1= absent to 7= extreme). The PANSS is reported to have satisfactory internal consistency, good interrater reliability and construct validity.

  Baseline (T0), post-intervention at week 4 (T4) and follow-up (week 8, T5)

Secondary Outcomes (11)

• Change and group differences in BNSS Brief Negative Symptom Scale

  Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)

• Change and group differences in SNS Negative Symptoms

  Baseline (T0), post-intervention at week 2 (T3), post-intervention at week 4 (T9) and follow-up (week 8, T5)

• Change and group differences in CDSS Calgary Depression Scale of Schizophrenia

  Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)

• Change and group differences in cortisol saliva levels

  Baseline (T0), pre- and post-intervention in week 1 - 4 (T1-T7) and follow-up (week 8, T5)

• Change and group differences in DASS-21 Depression, Anxiety, and Stress Scale

  aseline (T0), post-intervention at week 2 (T3), post-intervention at week 4 (T7) and follow-up (week 8, T9)

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

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.

Other: Oxytocin

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Oxytocin OTHER

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

Oxytocin

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, State of Berlin, 12203, Germany

Location

Related Publications (1)

• 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.

  PMID: 33434727 RESULT

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Marco Zierhut, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Kerem Böge, PD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Eric Hahn, PD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Dr.

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 18, 2023
• Study Start: September 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)