Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136390
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-11-04
Brief Title:
OXYMIND Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
OXYMIND Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OXYMIND
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None