Schizophrenia Spectrum Disorders (SSD)OXYMIND2NCT07265180
Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison
A study testing Oxytocin in people with Schizophrenia Spectrum Disorders (SSD), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia Spectrum Disorders (SSD)
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 8 Sep 2025to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 acute electroconvulsive therapy
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Campus Charité Mitte
Berlin, State of Berlin, 12203
Marco Zierhut, MD, 004930450517547, marco.zierhut@charite.de
Kerem Böge, Prof., 004930450517789, kerem.boege@charite.de
About this study
Official title: Oxytocin-Augmented Mindfulness-Based Group Psychotherapy for Patients With Schizophrenia Spectrum Disorders - an Oxytocin-dose Comparison (OXYMIND2.0)
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 lower NS by OXT administration in a positive social context of mindfulness-based group psychotherapy (MBGT) in SSD. The investigators also demonstrated that symptoms improved after MBGT. A more recent study suggests that, compared to placebo, administering OXT in a positive social context via MBGT leads to significant between-group differences favoring OXT, particularly in NS, affect, and stress. Building on these findings, the present study investigates the stability of these effects, along with psychological and biological markers, in a larger sample of individuals with SSD. 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 with a higher OXT dosage. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.
Read the 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 mindfulness-based group psychotherapy (MBGT) in SSD. The investigators also demonstrated that NS and other symptoms improved after MBGT. A more recent study suggests that, compared to placebo, administering OXT in a positive social context via MBGT leads to significant between-group differences favoring OXT, particularly in NS, affect, and stress. Building on these findings, the present study investigates the stability of these effects, along with psychological and biological markers, in a larger sample of individuals with SSD. 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 T0-T8 of the total score on the BNSS (Brief Negative Symptom Scale) after 4 weeks. The BNSS as a validated rater-based instrument designed for clinical trials will be collected by a blinded psychiatrist. MBGT-sessions by experienced psychotherapists take place once a week over four weeks in a group of six patients. They serve as a positive social context for OXT administration. Participants receive 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 (SSD)
- Being tested
- Oxytocin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinOther
Oxytocin nasal spray in combination with mindfulness based group therapy (MBGT).
PlaceboOther
Placebo nasal spray in combination with mindfulness based group therapy (MBGT).
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin (24 I.U. Syntocinon®) | Active comparator | The patients received a spray of 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 min after intranasal administration of oxytocin on social behavior, the dose was administered 30 min before the 50 min session. Receives: Other: Oxytocin |
| Oxytocin (48 I.U. Syntocinon®) | Active comparator | The patients received a spray of synthetic oxytocin (48 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 min after intranasal administration of oxytocin on social behavior, the dose was administered 30 min before the 50 min session. Receives: Other: Oxytocin |
| Placebo | Placebo comparator | The patients received a placebo nasal spray in combination with mindfulness-based group therapy (MBGT) over 4 weeks once a week. The dose was administered 30 min before the 50 min session for blinding reasons. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BNSS Brief Negative Symptom Scale
The Brief Negative Symptom Scale (BNSS) is a 13-item rater-based instrument designed for clinical trials and other studies that measures 5 domains: blunted affect, alogia, asociality, anhedonia, and avolition. The interrater, test-retest, and internal consistency of the instrument were strong, with respective intraclass correlation coefficients of 0.93 for the BNSS total score and values of 0.89-0.95 for individual subscales. The minimal score is 0 and the maximal score is 78. Higher scores indicate a worse outcome.
Measured: Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
Secondary outcomes (14)
Change and group differences in PANSS Positive and Negative Syndrome Scale
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 minimal score is 30 and the maximal score is 210. Higher scores indicate a worse outcome. The PANSS is reported to have satisfactory internal consistency, good interrater reliability and construct validity.
Measured: Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
Change and group differences in SNS Self-Evaluation of Negative Symptoms
The Self-Evaluation of Negative Symptoms (SNS) is a 20-item self-reported questionnaire with five subscales, namely alogia, avolition, anhedonia, social withdrawal and diminished emotional range. These subscales cluster on two factors, the apathy and emotional components. Participants can estimate the answer to each question on a scale from 0 (strongly disagree) to 2 (strongly agree). The minimal score is 0 and the maximal score is 40. Higher scores indicate a worse outcome. The scale was shown to have good internal consistency with Cronbach's alpha = .87.
Measured: Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
Change and group differences in CDSS Calgary Depression Scale of Schizophrenia
The Calgary Depression Scale for Schizophrenia (CDSS) is a nine item clinician rated outcome measure that assesses the level of depression in people with schizophrenia. It is the only depression scale designed to assess depression in people with a schizophrenia spectrum disorder. It distinguishes depressive symptoms from negative symptoms and is sensitive to change. The minimal score is 0 and the maximal score is 27. Higher scores indicate a worse outcome.
Measured: Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
Change and group differences in PSS Perceived Stress Scale
The Perceived Stress Scale (PSS) is a well-established, reliable, and valid 10-item self-report scale that measures perceived stress on a 5-point response scale (0 = "never", 1 = "almost never", 2 = "sometimes", 3 = "fairly often", 4 = "very often"). The German version of the PSS has demonstrated good internal consistency (Cronbach's α = 0.84). The minimal score is 10 and the maximal score is 50. Higher scores indicate a worse outcome.
Measured: Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
Change and group differences in SMQ Southampton Mindfulness Questionnaire
The Southampton Mindfulness Questionnaire (SMQ) comprises 16 items that are rated on a seven-point Likert-scale ranging from (6) "agree totally" to (0) "disagree totally". Consequently, the total score ranges from 0 to 96, with a higher score indicating higher mindfulness. The internal consistency of the German version of the SMQ was Cronbach's α = 0.89.
Measured: Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
Change and group differences in PANAS Positive and Negative Affect Scale
The Positive and Negative Affect Scale (PANAS) contains 20 items, each consisting of an adjective describing an emotion. The participants have to select how applicable this adjective is to their current state from 1 (not at all) to 5 (extremely). The minimal score is 20 and the maximal score is 100. Higher scores indicate a worse outcome.
Ten items are assigned to the positive (e.g. "Excited") as well as the negative scale (e.g. "Fearful"). The reliability of the PANAS ranges from .86 to .93.
Measured: Pre- and post-intervention in week 1-4 (T0-T7)
Change and group differences in stress via visual analogue scale (Bubbles)
Stress via visual analogue scale. Self-rating instrument to measure stress through four items on a seven-point Likert-scale ranging from "not at all" (0) to "extreme" (6) visualized through bubbles increasing in size. The minimal score is 0 and the maximal score is 24. Higher scores indicate a worse outcome.
Measured: Pre- and post-intervention in week 1-4 (T0-T7)
Change and group differences in GCQ-S Group Climate Questionnaire (Short Version)
The Group Climate Questionnaire [Short Version] (GCQ-S) is a 12 item questionnaire designed to assess individual group members' perceptions of the group's therapeutic environment. It consists of three domains: Engaged, conflict and avoiding and will be used as a self-report, such as a rater-based instrument. The minimal score is 0 and the maximal score is 72. Higher scores indicate a worse outcome.
Measured: Post-intervention in week 1-4 (T1, T3, T5, T7)
Change and group differences in PSP Personal and Social Performance scale
The Personal and Social Performance Scale (PSP) is a rater-based questionnaire used to assess social functioning in patients with SSD. The minimal score is 1 and the maximal score is 100. Higher scores indicate a better outcome. The PSP showed good test-retest reliability (ICC = 0.79) in patients with schizophrenia.
Measured: Baseline rating (T0) and post-intervention rating at week 4 (T8)
Change and group differences in endocannabinoid levels
Venous blood samples will be taken to determine the endocannabinoid levels to obtain an individual baseline and comparison level.
Measured: Pre- and post-intervention in week 1 (T0, T1), post-intervention in week 4 (T7) and follow-up 1 (week 8, T9)
Change and group differences in interleukin levels
Venous blood samples will be taken to determine the interleukin levels to obtain an individual baseline and comparison level.
Measured: Pre-intervention in week 1 (T0) and post-intervention in week 4 (T7)
Change and group differences in oxytocin levels
Venous blood samples will be taken to determine the oxytocin levels to obtain an individual baseline and comparison level.
Measured: Pre- and post-intervention in week 1 (T0, T1) and post-intervention in week 4 (T7)
Change and group differences in PBMC levels
Venous blood samples will be taken to determine the PBMC levels to obtain an individual baseline and comparison level.
Measured: Pre-intervention in week 1 (T0) and post-intervention in week 4 (T7)
Change and group differences in cortisol saliva levels
Saliva samples will be taken before and after each MBGT session to determine Cortisol saliva levels
Measured: Pre- and post-intervention in week 1-4 (T0-T7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start8 Sep 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia Spectrum Disorders (SSD)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Böge, Charite University, Berlin, Germany
- Investigators
- Marco Zierhut, MD, Principal investigator, Charite University, Berlin, GermanyKerem Böge, Prof., Principal investigator, Charite University, Berlin, GermanyEric Hahn, PD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265180
- Sponsor's protocol ID
- OXYMIND2.0
- Acronym
- OXYMIND2
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boge K, Bergmann N, Zierhut M, Hahne I, Braun A, Kraft J, Conell I, Ta TMT, Thomas N, Chadwick P, Ripke S, Hahn E. The relationship between mindfulness and empathy with the oxytocinergic system in persons with schizophrenia spectrum disorders - A proof-of-concept randomized controlled trial (OXYGEN). Int J Clin Health Psychol. 2024 Jul-Sep;24(3):100503. doi: 10.1016/j.ijchp.2024.100503. Epub 2024 Sep 10.
PubMed 39308779Zierhut M, Bergmann N, Hahne I, Wohlthan J, Kraft J, Braun A, Tam Ta TM, Hellmann-Regen J, Ripke S, Bajbouj M, Hahn E, Boge K. 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. J Psychiatr Res. 2024 Mar;171:222-229. doi: 10.1016/j.jpsychires.2024.01.014. Epub 2024 Jan 9.
PubMed 38309212Boge 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.
PubMed 33434727