The combination of oxytocin and mindfulness-based group therapy for empathy and negative symptoms in schizophrenia spectrum disorders - A double-blinded, randomized, placebo-controlled pilot study.

Zierhut M, Bergmann N, Hahne I, Wohlthan J, Kraft J, Braun A, Tam Ta TM, Hellmann-Regen J, Ripke S, Bajbouj M, Hahn E, Böge K

Journal of psychiatric research9 Jan 2024Cited by 16 (Europe PMC)

PMID38309212DOI10.1016/j.jpsychires.2024.01.014PepBankPUB-38309212

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Summary

Treatment options for social cognition and negative symptoms in schizophrenia spectrum disorders (SSD) remain limited. Oxytocin could be a promising augmentation approach, but the social context influences the effect in humans. This pilot study hypothesized that oxytocin in a positive social setting through mindfulness-based group therapy (MBGT) would positively affect empathy and negative symptoms as well as affect and stress in an exploratory approach in SSD. An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin. Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each. A 2 × 2 mixed model ANCOVA design was calculated to assess empathy by the Interpersonal Reactivity Index and the Multifaceted Empathy Test and negative symptoms by the Self-Evaluation of Negative Symptoms. No benefit of oxytocin compared to placebo on empathy was observed, but significant between-group differences favoring oxytocin were found regarding the negative symptoms Diminished emotional range and Avolition. Negative affect and stress were significantly reduced compared to baseline. Mindfulness increased in both groups. Results indicated protocol adherence and retention rate of 91.1%, a drop-out rate of 8.9 % and a completion of 96 % of all sessions by the participants. No severe adverse events or side effects were reported. Our findings indicate proof-of-concept and suggest a potential role of oxytocin on negative symptoms and related variables in SSD in combination with MBGT. Future research should examine the stability of these effects with larger sample sizes.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In people with schizophrenia spectrum disorders in mindfulness-based group therapy, oxytocin gave no benefit on empathy compared with placebo.
In plain wordsIn people with schizophrenia spectrum disorders, oxytocin did not improve empathy more than placebo did.
Peptide
Oxytocin
Outcome
No significant changeEmpathy (IRI and Multifaceted Empathy Test)
Study
n = 41
Comparator
Placebo
Outcome group
Social behavior and cognition · Mental health and mood
Studied dose
24 I.U. · intranasal · two sessionsAs given in this study (human).
Source sentences
Summary
No benefit of oxytocin compared to placebo on empathy was observed
2 context sentences(design, population, supporting numbers)
Summary · context
An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin.
Summary · context
Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each.
Show in the study text Report a problemFND-3830921201
02HumanRandomized controlled trialEfficacy outcome
In people with schizophrenia spectrum disorders in mindfulness-based group therapy, between-group differences in diminished emotional range favoured oxytocin over placebo.
In plain wordsIn people with schizophrenia spectrum disorders, oxytocin did better than placebo on diminished emotional range.
Peptide
Oxytocin
Outcome
DecreaseNegative symptom: Diminished emotional range
Study
n = 41
Comparator
Placebo
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
24 I.U. · intranasal · two sessionsAs given in this study (human).
Source sentences
Summary
significant between-group differences favoring oxytocin were found regarding the negative symptoms Diminished emotional range and Avolition.
2 context sentences(design, population, supporting numbers)
Summary · context
An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin.
Summary · context
Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each.
Show in the study text Report a problemFND-3830921202
03HumanRandomized controlled trialEfficacy outcome
In people with schizophrenia spectrum disorders in mindfulness-based group therapy, between-group differences in avolition favoured oxytocin over placebo.
In plain wordsIn people with schizophrenia spectrum disorders, oxytocin did better than placebo on avolition.
Peptide
Oxytocin
Outcome
DecreaseNegative symptom: Avolition
Study
n = 41
Comparator
Placebo
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
24 I.U. · intranasal · two sessionsAs given in this study (human).
Source sentences
Summary
significant between-group differences favoring oxytocin were found regarding the negative symptoms Diminished emotional range and Avolition.
2 context sentences(design, population, supporting numbers)
Summary · context
An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin.
Summary · context
Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each.
Show in the study text Report a problemFND-3830921203
04HumanRandomized controlled trialEfficacy outcome
In people with schizophrenia spectrum disorders, negative affect and stress were significantly reduced compared with baseline; the abstract does not say whether this differed by oxytocin or placebo.
In plain wordsIn people with schizophrenia spectrum disorders, negative affect and stress fell from baseline; the report does not separate oxytocin from placebo.
Peptide
Oxytocin
Outcome
Not applicableNegative affect and stress versus baseline
Study
n = 41
Comparator
Baseline
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
24 I.U. · intranasal · two sessionsAs given in this study (human).
Source sentences
Summary
Negative affect and stress were significantly reduced compared to baseline.
2 context sentences(design, population, supporting numbers)
Summary · context
An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin.
Summary · context
Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each.
Show in the study text Report a problemFND-3830921204
05HumanRandomized controlled trialEfficacy outcome
In people with schizophrenia spectrum disorders, mindfulness increased in both the oxytocin and placebo groups.
In plain wordsIn people with schizophrenia spectrum disorders, mindfulness rose in both the oxytocin and placebo groups.
Peptide
Oxytocin
Outcome
Not applicableMindfulness
Study
n = 41
Comparator
Baseline
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
24 I.U. · intranasal · two sessionsAs given in this study (human).
Source sentences
Summary
Mindfulness increased in both groups.
2 context sentences(design, population, supporting numbers)
Summary · context
An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin.
Summary · context
Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each.
Show in the study text Report a problemFND-3830921205
06HumanRandomized controlled trialOther
In the pilot study, the retention rate was 91.1%.
In plain wordsIn this small pilot study, 91.1% of participants stayed in the study.
Peptide
Oxytocin
Outcome
Not applicableProtocol adherence and retention rate
Study
n = 41
Outcome group
Treatment adherence and retention · Mental health and mood
Studied dose
24 I.U. · intranasal · two sessionsAs given in this study (human).
Measurements
Retention rate
91.1%
all participants
Source sentences
Summary
protocol adherence and retention rate of 91.1%
2 context sentences(design, population, supporting numbers)
Summary · context
An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin.
Summary · context
Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each.
Show in the study text Report a problemFND-3830921206
07HumanRandomized controlled trialOther
In the pilot study, the drop-out rate was 8.9 %.
In plain wordsIn this small pilot study, 8.9 % of participants dropped out.
Peptide
Oxytocin
Outcome
Not applicableDrop-out rate
Study
n = 41
Outcome group
Treatment adherence and retention · Mental health and mood
Studied dose
24 I.U. · intranasal · two sessionsAs given in this study (human).
Measurements
Drop-out rate
8.9%
all participants
Source sentences
Summary
a drop-out rate of 8.9 %
2 context sentences(design, population, supporting numbers)
Summary · context
An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin.
Summary · context
Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each.
Show in the study text Report a problemFND-3830921207
08HumanRandomized controlled trialOther
In the pilot study, participants completed 96 % of all sessions.
In plain wordsIn this small pilot study, participants completed 96 % of all sessions.
Peptide
Oxytocin
Outcome
Not applicableSession completion
Study
n = 41
Outcome group
Treatment adherence and retention · Mental health and mood
Studied dose
24 I.U. · intranasal · two sessionsAs given in this study (human).
Measurements
Session completion
96%
all sessions
Source sentences
Summary
a completion of 96 % of all sessions by the participants.
2 context sentences(design, population, supporting numbers)
Summary · context
An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin.
Summary · context
Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each.
Show in the study text Report a problemFND-3830921208
09HumanRandomized controlled trialSafety outcome
In the pilot study, no severe adverse events or side effects were reported with oxytocin.
In plain wordsIn this small pilot study, no severe adverse events or side effects were reported.
Peptide
Oxytocin
Outcome
No significant changeSevere adverse events or side effects
Study
n = 41
Comparator
Placebo
Outcome group
Adverse events · Mental health and mood
Studied dose
24 I.U. · intranasal · two sessionsAs given in this study (human).
Source sentences
Summary
No severe adverse events or side effects were reported.
2 context sentences(design, population, supporting numbers)
Summary · context
An experimental, randomized, double-blinded (participants, psychotherapists), placebo-controlled pilot study with 41 individuals with SSD was conducted at the Charité - Universitätsmedizin Berlin.
Summary · context
Oxytocin or placebo (24 I.U.) was administered intranasally 45 min before two sessions of MBGT each.
Show in the study text Report a problemFND-3830921209

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 ongoing · source ClinicalTrials.gov (opens in a new tab)

RecruitingNot applicableNCT07265180

Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison

Charite University, Berlin, Germanyn = 1208 Sept 2025 to est. 30 Nov 2026

Schizophrenia Spectrum Disorders (SSD)

Trial page ClinicalTrials.govUpdated 21 Aug 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 02:47 UTC
First added · source update from Europe PMC

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