An interventional study of Oxytocin and Placebo in Schizophrenia Spectrum Disorders (SSD), sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
Among 11 studies in Schizophrenia by Charite University, Berlin, Germany — 2 open to participants now, 2 under way, none of them phase 3. Schizophrenia · Charite University, Berlin, Germany.
Among the 11 studies in Schizophrenia by Charite University, Berlin, Germany, this one is the only one that started in 2025, is one of 8 with no phase, and was the 10th registered.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
Browse Schizophrenia studies →2 of the 11 studies in Schizophrenia by Charite University, Berlin, Germany are open now, in 1 country. Recruiting first, the newest first:
Charite University, Berlin, Germany · Sites in Germany
By country, each count listing its studies:
Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 120 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Median enrollment 60 across the 9 interventional studies, 130 across the 2 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
1 of the studies in Schizophrenia by Charite University, Berlin, Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07265180Charite University, Berlin, GermanyOxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison | 2026-11-30 |
Among the 11 studies in Schizophrenia by Charite University, Berlin, Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Oxytocin
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.
Other: Oxytocin
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.
Other: Placebo
Oxytocin nasal spray in combination with mindfulness based group therapy (MBGT).
Placebo nasal spray in combination with mindfulness based group therapy (MBGT).
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.
Time frame: 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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Pre- and post-intervention in week 1-4 (T0-T7)
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Nov 2026, 14 months after the start.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 14 months is below that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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Charite University, Berlin, Germany →