The Association of Affective Resonance With Empathy Modulated by Negative Symptomatology and Oxytocin

NCT05247151 | Completed

• 1 other identifier: 3000194
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

In previous studies the neuropeptide oxytocin has been in particular associated with social enhancing and anxiety relieving effects. The purpose of this study is to investigate the effect of oxytocin on empathy in patients with schizophrenia. On a neurobiological level, social effects mediated by oxytocin are based on oxytocin's influence on the complexly regulated mesocorticolimbic dopamine system. Preliminary studies have already shown that oxytocin increases neuronal connections between social reward expectancy networks and networks for socioemotional processes in the brain, which on a behavioral level leads to increased social activation, motivation, and also improved social perception. Furthermore, an increase in empathy modulated by the amygdala has been shown in healthy individuals following oxytocin administration. In particular, primary psychotic disorders, such as schizophrenia, are associated with deficits in the domain of social cognition, including empathy, with the degree of negative symptoms playing an important mediating role. Another study demonstrated a significantly lower expression of empathy as well as a significantly lower oxytocin level in patients with schizophrenia compared to healthy subjects. According to the hypothesis of social salience, which describes an increased importance of certain social stimuli, the effect of oxytocin varies depending on specific contexts and individual variables of the perceiving person, such as the degree of negative symptoms. Therefore, based on such preliminary findings, the research project will explore an effect of oxytocin on empathy within a positively experienced and controlled context, especially in patients with schizophrenia regarding their negative symptoms.

Conditions

Schizophrenia Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• Change in empathy

  Measured via the Interpersonal Reactivity Index (SPF-IRI). The IRI assesses four dimensions of empathic responding (Perspective taking, Empathic concern, Personal distress, Fantasy) on a 5-point Likert scale ranging from "Does not describe me well" (1) to "Describes me very well" (5). Higher scores mean a better outcome.

  Change from baseline (before intervention) to directly after intervention.

Secondary Outcomes (1)

• Change of negative symptoms

  Change from baseline (before intervention) to directly after intervention.

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

The patients received either a spray of the synthetic oxytocin (24 I.U. Syntocinon®) with mindfulness-bases grow therapy (MBGT) as a positive social context in each condition. Due to an effect latency of 30-80 mins after intranasal administration of oxytocin on social behavior, the dose was administered 30 min before the 50-min session.

Other: Oxytocin

Placebo

PLACEBO COMPARATOR

The patients received either a spray of the synthetic placebo (24 I.U.) with mindfulness-bases grow therapy (MBGT) as a positive social context in each condition. Due to an effect latency of 30-80 mins after intranasal administration of oxytocin on social behavior, the dose was administered 30 min before the 50-min session.

Other: Placebo

Interventions

Oxytocin OTHER

Oxytocin nasal spray in a positive social setting.

Oxytocin

Placebo OTHER

Placebo nasal spray in a positive social setting.

Placebo

Eligibility Criteria

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

You may qualify if:

• Informed consent
• Psychiatric diagnosis from the schizophrenic spectrum (ICD-10: F2x.x spectrum) for group of patients
• Mild to moderate positive symptoms (5 \< positive symptoms on individual items using P-PANSS)
• Age: 18 - 65 years
• German should either be the mother tongue or spoken at a native level.

You may not qualify if:

• Acute psychotic episode with severe positive symptoms (ICD-10: F2 spectrum, 5 ≥ 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

Location

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, Dr.

  Charitè - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

• Eric Hahn, PD

  Charitè - Universitätsmedizin Berlin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: February 18, 2022
• Study Start: August 2, 2021
• Primary Completion: November 25, 2021
• Study Completion: January 30, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)