An interventional study of Inpatient Care in a Closed Unit Incorporating Soteria Elements and Conventional Closed Psychiatric Inpatient Care in Psychotic Disorders, sponsored by Jerusalem Mental Health Center. Recruiting at 1 site in Israel. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Jerusalem Mental Health Center · Not applicable, Interventional, and Treatment
Among 44 studies in Psychotic Disorders with a site in Israel — 6 open to participants now, 7 under way, 3 of them phase 3. Psychotic Disorders · Israel.
Among the 44 studies in Psychotic Disorders with a site in Israel, this one is the 14th largest by planned enrollment of the 35 interventional ones that give a count, is the only one that started in 2025, is one of 9 with no phase, and was the 44th registered.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
Browse Psychotic Disorders studies →6 of the 44 studies in Psychotic Disorders with a site in Israel are open now. Recruiting first, the newest first:
University of Oxford · Sites in Israel, Austria, Germany and 6 more countries
Amit Lotan · Sites in Israel
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Sites in Israel, United States, Argentina and 22 more countries
Sheba Medical Center · Sites in Israel
University of Oxford · Sites in Israel, Germany, Greece and 5 more countries
A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →
Of the 205 Psychotic Disorders studies recruiting now, 53 (26%) set no upper age limit and 143 (70%) stop at 75 or younger; 51 take children under 18; 41 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 17 · Phase 4 6
First in 2000; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 200 is above the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Median enrollment 199 across the 35 interventional studies, 90 across the 8 observational. Of the 19 that completed or were terminated, 6 (32%) have results posted.
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9 of 44 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Jerusalem Mental Health Center as lead sponsor.
Jerusalem Mental Health Center has 1 study filed under Psychotic Disorders — fewer than ten, so there is no comparison to draw.
1 of the studies in Psychotic Disorders with a site in Israel that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
Among the 44 studies in Psychotic Disorders with a site in Israel, from their registry updates:
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This prospective study compares two models of inpatient psychiatric care for adults experiencing an acute psychotic episode of moderate to severe intensity that requires admission to a closed psychiatric setting. Participants may have a history of previous psychiatric hospitalizations.
After informed consent and completion of all baseline assessments, eligible participants are randomly assigned to either a small closed unit incorporating Soteria elements or a conventional closed psychiatric ward at the Jerusalem Mental Health Center. Treatment allocation remains concealed during the baseline assessment, so that participants and researchers completing the initial assessments do not know the participant's future treatment setting.
Because the study is conducted under real-world emergency psychiatric conditions, random allocation may not always be feasible because of clinical urgency, bed availability, administrative constraints, or difficulty obtaining consent and completing study procedures during an acute psychotic episode. When randomization cannot be implemented, eligible participants may still be enrolled and their method of allocation will be documented.
The closed unit incorporating Soteria elements provides care in a smaller setting of approximately 10 patients and emphasizes a calm and less institutional environment, supportive therapeutic relationships, shared decision-making whenever possible, personal autonomy, reduced reliance on coercive practices, and careful optimization of medication. The conventional closed ward provides standard acute inpatient psychiatric care in a larger ward setting.
The primary aims are to compare the relationship between antipsychotic medication dosage and improvement in psychotic symptoms, as well as therapeutic alliance and satisfaction with care, between the two treatment settings. Secondary outcomes include personal recovery, sense of dignity, internalized stigma, adverse events and coercive interventions during hospitalization, length of stay, and other clinical and post-discharge outcomes. Psychiatric readmission within one year after discharge is included as a primary outcome.
Baseline assessments are completed before treatment allocation is disclosed. At discharge and follow-up, full blinding is not always feasible because participants may reveal their treatment setting; however, outcome assessments will be conducted with partial blinding whenever possible, and the success of blinding will be documented.
The primary statistical analysis will focus on participants who were randomly assigned. Additional analyses will compare randomly and non-randomly allocated participants and will include all eligible participants using statistical adjustment for relevant baseline differences and potential confounding. Sensitivity analyses restricted to the randomized sample will be conducted to assess the robustness of the findings.
To support retention at the one-year follow-up assessment, participants who attend the Jerusalem Mental Health Center in person to complete the follow-up assessments will receive 100 New Israeli Shekels (approximately 33 United States dollars) as compensation for their time and participation in the follow-up visit.
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:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive inpatient psychiatric treatment in a small closed unit of approximately 10 patients that incorporates Soteria principles. The treatment environment emphasizes a calm and less institutional atmosphere, supportive and sustained therapeutic relationships, shared decision-making whenever possible, personal autonomy, relational safety, reduced reliance on coercive practices, and careful optimization of psychiatric medication.
Other: Inpatient Care in a Closed Unit Incorporating Soteria Elements
Participants receive standard acute inpatient psychiatric treatment in a conventional closed psychiatric ward. Care includes routine psychiatric assessment, medication management, nursing care, multidisciplinary treatment, structured ward procedures, and other standard interventions provided according to clinical need.
Other: Conventional Closed Psychiatric Inpatient Care
A psychiatric inpatient treatment model delivered in a small closed unit incorporating Soteria principles, including a less institutional environment, intensive supportive relationships, shared decision-making, promotion of autonomy, relational safety, reduced reliance on coercion, and medication optimization.
Also known as: Soteria-Informed Closed Unit, Closed Soteria
Standard psychiatric inpatient treatment provided in a conventional closed ward, including psychiatric and nursing care, medication management, multidisciplinary treatment, structured supervision, and routine ward procedures.
Also known as: Standard Closed Ward, Conventional Closed Ward
Change in Psychotic Symptom Severity From Admission to Discharge
Psychotic symptom severity will be assessed using the six-item Positive and Negative Syndrome Scale (PANSS-6) at admission and discharge. The PANSS-6 includes three positive-symptom items and three negative-symptom items. Each item is rated from 1 to 7, and total scores range from 6 to 42, with higher scores indicating greater psychotic symptom severity. Change in PANSS-6 total score from admission to discharge will be compared between the two treatment settings.
Time frame: Baseline and at discharge, up to 180 days after admission
Therapeutic Alliance With the Treatment Team Assessed by the Session Alliance Inventory
Therapeutic alliance will be assessed at discharge using the patient version of the six-item Session Alliance Inventory (SAI), adapted so that all items refer to the treatment team as a whole rather than to an individual therapist. Each item is rated on a 1-to-7 scale, with higher scores indicating a stronger perceived therapeutic alliance. The total score is calculated by summing the six items and ranges from 6 to 42.
Time frame: At discharge, up to 180 days after admission
Satisfaction With Care Assessed by the Client Satisfaction Questionnaire-8
Satisfaction with inpatient psychiatric care will be assessed at discharge using the eight-item Client Satisfaction Questionnaire (CSQ-8). Each item is rated on a 1-to-4 scale. The total score is calculated by summing the eight items and ranges from 8 to 32, with higher scores indicating greater satisfaction with care.
Time frame: At discharge, up to 180 days after admission
Psychiatric Readmission Within One Year After Discharge
Psychiatric readmission during the first year after discharge will be assessed as a binary outcome indicating whether the participant was readmitted to a psychiatric hospital within one year of discharge. The proportion of participants with at least one psychiatric readmission will be compared between the two treatment settings.
Time frame: 1 year after discharge
Antipsychotic Medication Dose During Hospitalization
Antipsychotic medication dosage will be assessed at baseline, on Day 14 for participants who remain hospitalized at that time, and at discharge. Antipsychotic doses will be converted to olanzapine-equivalent doses. Medication dose trajectories over time will be compared between the two treatment settings.
Time frame: Baseline, Day 14 if still hospitalized, and at discharge, up to 180 days after admission
Anxiolytic Medication Dose During Hospitalization
Anxiolytic medication dosage will be assessed at baseline, on Day 14 for participants who remain hospitalized at that time, and at discharge. Anxiolytic doses will be converted to diazepam-equivalent doses. Medication dose trajectories over time will be compared between the two treatment settings.
Time frame: Baseline, Day 14 if still hospitalized, and at discharge, up to 180 days after admission
Time to First Psychiatric Readmission Within One Year After Discharge
For participants who experience a psychiatric readmission within one year after discharge, time from discharge to the first psychiatric readmission will be measured in days. Time to first psychiatric readmission will be compared between the two treatment settings.
Time frame: From discharge through 1 year after discharge
Legal Admission Status and Changes During Hospitalization
Legal admission status will be recorded at admission and throughout hospitalization. Status will be categorized as voluntary admission or involuntary admission under a legal hospitalization order. Changes in legal status during hospitalization will be recorded, including transition from involuntary to voluntary status or from voluntary to involuntary status. The time in days from admission to the first change in legal status, as well as the direction and number of status changes, will be compared between the two treatment settings.
Time frame: Baseline through discharge, up to 180 days after admission
Adverse Events and Interventions During Hospitalization
Adverse events occurring during hospitalization will be recorded, including the date and type of each event and the intervention used in response. The number and types of adverse events and related interventions will be compared between the two treatment settings.
Time frame: From admission through discharge, up to 180 days
Change in Sense of Dignity From Admission Through One-Year Follow-Up
Sense of dignity will be assessed using the 15-item Sense of Dignity Scale. Each item is rated on a 1-to-4 scale, and the total score is calculated by summing the 15 items, with higher scores indicating a greater sense of dignity, self-worth, autonomy, and meaning. Scores will be assessed at admission, discharge, and approximately one year after discharge. Changes over time and differences between the two treatment settings will be examined.
Time frame: Baseline, at discharge up to 180 days after admission, and 1 year after discharge
Change in Self-Stigma From Admission Through One-Year Follow-Up
Self-stigma will be assessed using the 40-item Self-Stigma of Mental Illness Scale (SSMIS). The scale comprises four 10-item subscales: awareness of public stereotypes, agreement with public stereotypes, application of stereotypes to oneself, and harm to self-esteem. Each item is rated on a 1-to-9 scale. A separate score will be calculated for each subscale, with higher scores indicating greater endorsement of the corresponding stage of self-stigma. Scores will be assessed at admission, discharge, and approximately one year after discharge. Changes over time and differences between the two treatment settings will be examined.
Time frame: Baseline, at discharge up to 180 days after admission, and 1 year after discharge
Discharge Reason and Post-Discharge Disposition
At discharge, the reason for discharge and the participant's planned post-discharge disposition will be recorded. Post-discharge disposition will include the planned living arrangement and the planned psychiatric or psychosocial follow-up setting. The distribution of discharge reasons, residential destinations, and planned follow-up treatment settings will be compared between the two treatment groups.
Time frame: At discharge, up to 180 days after admission
Psychotic Symptom Severity at One-Year Follow-Up
Psychotic symptom severity will be assessed approximately one year after discharge using the six-item Positive and Negative Syndrome Scale (PANSS-6). The scale includes three positive-symptom items and three negative-symptom items. Each item is rated from 1 to 7, and total scores range from 6 to 42, with higher scores indicating greater psychotic symptom severity. PANSS-6 scores at one-year follow-up will be compared between the two treatment settings and with scores obtained at admission and discharge.
Time frame: Approximately one year after discharge
Antipsychotic Medication Dose at One-Year Follow-Up
Antipsychotic medication use and dosage will be assessed approximately one year after discharge. Antipsychotic doses will be converted to olanzapine-equivalent doses. Medication dose at one-year follow-up will be compared between the two treatment settings and with doses recorded at baseline, Day 14 for participants who remained hospitalized at that time, and discharge.
Time frame: 1 year after discharge
Personal Recovery at One-Year Follow-Up
Personal recovery will be assessed approximately one year after discharge using the 24-item Recovery Assessment Scale (RAS-24). Each item is rated on a 1-to-5 scale. Higher scores indicate a stronger subjective sense of recovery, including greater hope, goal orientation, willingness to seek help, reliance on others, and reduced domination by symptoms. Scores will be compared between the two treatment settings.
Time frame: Approximately one year after discharge
Anxiolytic Medication Dose at One-Year Follow-Up
Anxiolytic medication use and dosage will be assessed approximately one year after discharge. Anxiolytic doses will be converted to diazepam-equivalent doses. Medication dose at one-year follow-up will be compared between the two treatment settings and with doses recorded at baseline, Day 14 for participants who remained hospitalized at that time, and discharge.
Time frame: 1 year after discharge
Retrospective Evaluation of Therapeutic Alliance at One-Year Follow-Up
Approximately one year after discharge, participants will retrospectively evaluate the therapeutic alliance they experienced with the inpatient treatment team using the adapted patient version of the six-item Session Alliance Inventory (SAI). All items refer to the treatment team as a whole rather than to an individual therapist. Each item is rated on a 1-to-7 scale, and the total score ranges from 6 to 42, with higher scores indicating a stronger perceived therapeutic alliance. One-year ratings will be compared between the two treatment settings and with ratings obtained at discharge.
Time frame: Approximately one year after discharge
Retrospective Satisfaction With Inpatient Care at One-Year Follow-Up
Approximately one year after discharge, participants will retrospectively evaluate their satisfaction with the inpatient care they received using the eight-item Client Satisfaction Questionnaire (CSQ-8), adapted as needed to refer specifically to the previous hospitalization. Each item is rated on a 1-to-4 scale, and the total score ranges from 8 to 32, with higher scores indicating greater satisfaction with care. One-year ratings will be compared between the two treatment settings and with ratings obtained at discharge.
Time frame: Approximately one year after discharge
Length of Stay in the Study Inpatient Setting
Length of stay will be calculated as the number of days from admission to the assigned study inpatient setting until discharge from that setting. Length of stay will be compared between the closed unit incorporating Soteria elements and the conventional closed psychiatric ward.
Time frame: From admission through discharge, up to 180 days
Mood Stabilizer Medication Dose From Admission Through One-Year Follow-Up
Mood stabilizer medication use and dosage will be assessed at baseline, on Day 14 for participants who remain hospitalized at that time, at discharge, and 1 year after discharge. Mood stabilizer doses will be converted to lithium-equivalent doses. Changes over time and differences between the two treatment settings will be explored.
Time frame: Baseline, Day 14 if still hospitalized, at discharge up to 180 days after admission, and 1 year after discharge
Antidepressant Medication Dose From Admission Through One-Year Follow-Up
Antidepressant medication use and dosage will be assessed at baseline, on Day 14 for participants who remain hospitalized at that time, at discharge, and 1 year after discharge. Antidepressant doses will be converted to fluoxetine-equivalent doses. Changes over time and differences between the two treatment settings will be explored.
Time frame: Baseline, Day 14 if still hospitalized, at discharge up to 180 days after admission, and 1 year after discharge
Plan to share: Yes — De-identified individual participant data underlying the results reported in study publications may be shared. Shared data may include demographic and clinical variables, treatment allocation, symptom measures, medication data, patient-reported outcome measures, hospitalization characteristics, and follow-up outcomes. Direct identifiers and information that could reasonably permit participant identification will not be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available beginning after publication of the primary study results and will remain available for at least 5 years thereafter.
Access criteria: De-identified data will be made available to qualified researchers upon reasonable written request to the study investigators. Requests must include a scientifically sound research proposal and specify the data requested and intended analyses. Access will be subject to approval by the study investigators and, when required, the relevant institutional or ethics authorities, and may require a data use agreement. Data may be used only for the approved research purpose and may not be used to attempt to identify individual participants.
Started Sep 2025 (actual). Primary completion is estimated for May 2028, 31 months after the start.
Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 31 months is close to that.
Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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