Schizophrenia Spectrum DisordersOXYMINDNCT06136390
OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia
A study testing Oxytocin in people with Schizophrenia Spectrum Disorders, 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
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 30 Sep 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 electroconvulsive therapy
Show all 13Show fewer
- 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.
Germany1 site
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, State of Berlin, 12203
About this study
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.
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 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, i.e. 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.
- Conditions
- Schizophrenia Spectrum Disorders
- 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 | 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)
Change and group differences in SNS Negative Symptoms
This 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 3 (strongly agree). The scale was shown to have good internal consistency with Cronbach's alpha = .87.
Measured: 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
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.
Measured: Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)
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: 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
The 21-item Depression, Anxiety, and Stress Scale (DASS-21) is assessed on a four-point Likert-scale ranging from (0) "did not apply to me at all over the last week" to (3) "applied to me very much last week." It shows internal consistencies of α > 0.80 across the three subscales and has shown to be a useful measurement tool for patients with SSD.
Measured: aseline (T0), post-intervention at week 2 (T3), post-intervention at week 4 (T7) and follow-up (week 8, T9)
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.
Measured: Baseline (T0), pre- and post-intervention in week 1 - 4 (T1-T7) and follow-up (week 8, T8)
Change and group differences in PANAS (Positive and Negative Affect Scale)
The 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). 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: Baseline (T0), pre- and post-intervention in week 1 - 4 (T1-T7) and follow-up (week 8, T8)
Change and group differences in PSP Social Functioning
The Personal and Social Performance Scale (PSP) is a rater-based questionnaire used to assess social functioning in patients with SSD. The PSP showed good test-retest reliability (ICC = 0.79) in patients with schizophrenia.
Measured: Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)
Change and group differences in SMQ Mindfulness
The 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 (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)
Change and group differences in GCQ-S Group Climate Questionnaire (Short Version)
The 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.
Measured: Post-intervention at week 1-4 (T1-T7)
Change and group differences in endocannibinoid levels
Venous blood samples will be taken to determine the endocannibinoid levesls to obtain an individual baseline and comparison level.
Measured: Baseline (T0), post-intervention week 1 (T1), post-intervention week 4 (T7) and follow-up (week 8, T8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Sep 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia Spectrum DisordersStudies 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
- 42 participants (actual)
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, PD, Principal investigator, Charite University, Berlin, GermanyEric Hahn, PD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136390
- Sponsor's protocol ID
- 401743
- Acronym
- OXYMIND
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2023
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33434727
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT06136390
- Acronym / sponsor ID
- OXYMIND / 401743
- Conditions
- Schizophrenia Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, i.e. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Other: OxytocinThe 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. |
| Placebo | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinOxytocin nasal spray in combination with mindfulness based group therapy (MBGT). | Other | Oxytocin |
| PlaceboPlacebo nasal spray in combination with mindfulness based group therapy (MBGT). | Other | Placebo |
Primary outcome
Change in PANSS Negative Symptoms
Time frame: Baseline (T0), post-intervention at week 4 (T4) and follow-up (week 8, T5)
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.
11 secondary outcomes
Change and group differences in BNSS Brief Negative Symptom Scale
Time frame: Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)
Change and group differences in SNS Negative Symptoms
Time frame: 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
Time frame: Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)
Change and group differences in cortisol saliva levels
Time frame: 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
Time frame: aseline (T0), post-intervention at week 2 (T3), post-intervention at week 4 (T7) and follow-up (week 8, T9)
Change and group differences in stress via visual analogue scale (Bubbles)
Time frame: Baseline (T0), pre- and post-intervention in week 1 - 4 (T1-T7) and follow-up (week 8, T8)
Change and group differences in PANAS (Positive and Negative Affect Scale)
Time frame: Baseline (T0), pre- and post-intervention in week 1 - 4 (T1-T7) and follow-up (week 8, T8)
Change and group differences in PSP Social Functioning
Time frame: Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)
Change and group differences in SMQ Mindfulness
Time frame: Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8)
Change and group differences in GCQ-S Group Climate Questionnaire (Short Version)
Time frame: Post-intervention at week 1-4 (T1-T7)
Change and group differences in endocannibinoid levels
Time frame: Baseline (T0), post-intervention week 1 (T1), post-intervention week 4 (T7) and follow-up (week 8, T8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 33434727Boge 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Zierhut, MD principal investigator
Charite University, Berlin, Germany
Kerem Böge, PD principal investigator
Charite University, Berlin, Germany
Eric Hahn, PD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Schizophrenia Spectrum Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PANSS Negative Symptoms (time frame: Baseline (T0), post-intervention at week 4 (T4) and follow-up (week 8, T5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.