SchizophreniaVR-SCHIZONCT06588270
Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia
A study testing Virtual Reality Therapy for the Negative Symptoms of Schizophrenia in people with Schizophrenia, run by Hospital de la Florida Dra. Eloiza Diaz at 1 site in Chile.
Trial summary
A randomised, controlled, double-blind clinical trial will be carried out to evaluate the effectiveness of a VR assisted treatment for negative symptoms in people with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Virtual Reality Therapy for the Negative Symptoms of Schizophrenia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChile
- Study dates
- 2 May 2022to Sep 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia made by the treating psychiatrist and corroborated by a team's psychiatrist under CIE-10 criteria.
- Age between 18 to 65 years-old.
- Outpatient setting,
- Clinical stability defined as no psychiatric hospitalizations in the last 6 months and not currently on queue for psychiatric hospitalization.
- No concomitant active substance abuse disorder, excluding nicotine.
- Subjects are capable of providing informed consent.
Who cannot join
- Previous diagnosis of learning disability according either to ICD- 10 or clinical history
- Verbal expression difficulties, determined by language or medical causes.
- Deafness and/or blindness.
- Other physical handicaps to use VR devices.
- Predominant positive symptoms, defined as PANNS-C > 0.
- Catatonic symptoms.
- Previous epilepsy diagnosis.
- Neurodegenerative disease.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clínico La Florida
Santiago, Santiago Metropolitan
Ximena Fuentes, MD, +56992241711, xfuentesmartinez@gmail.com
About this study
Official title: Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia: Study Protocol for a Randomized Controlled Trial
A randomised, controlled, double-blind clinical trial will be carried out to evaluate the effectiveness of a VR assisted treatment for negative symptoms in people with schizophrenia. Patients with a standardised diagnosis of schizophrenia meeting the inclusion criteria will receive 12 weekly sessions of VR assisted therapy plus treatment as usual (TAU). A control group will be exposed to a neutral VR environment plus TAU. The hypothesis is that patients who are treated with active VR assisted therapy will have less negative symptoms as rated by the PANSS-N scale, compared to the control group.
The protocol was approved by the hospital ethics committee of the Servicio de Salud Metropolitano Suroriente. Patients sign an informed consent form, from which they may withdraw at any point during the intervention.
- Conditions
- Schizophrenia
- Being tested
- Virtual Reality Therapy for the Negative Symptoms of Schizophrenia, Sham- VR
- Keywords
- Schizophrenia, Virtual reality, Negative symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Therapy for the Negative Symptoms of SchizophreniaBehavioural
VRTNSS is a 12-session therapy using psychological intervention principles. Each therapy session will involve engaging with different VR based tasks where participants can experience different activities.
Sham- VRBehavioural
Patients will attend to VR sessions without the software created activities for treatment (sham-VR).
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality-based therapy | Experimental | The intervention group will receive a VR experience with a treatment software. The aim is to immerse the patient in an interactive environment that invites him/her to explore and complete goal-directed activities with sensory, visual and/or auditory rewards.
The therapy will be delivered with the support of a therapist once per week for 12 consecutive weeks. Each therapy session will last approximately 20 minutes. Receives: Behavioral: Virtual Reality Therapy for the Negative Symptoms of Schizophrenia |
| Sham -VR | Sham comparator | Control group's patients will continue pharmacological and non pharmacological usual treatment. Additionally, these patients will attend to VR sessions without the software created activities for treatment (sham-VR). Sessions will be the same length and quantity as the intervention group's sessions. Receives: Behavioral: Sham- VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative symptoms
The primary outcome will be the difference in the rate of change in negative symptoms at 3 months of follow-up. Negative symptoms are measured with the Positive and negative syndrome scale (PANSS) negative subscale. Scale's scoring system ranges from 7 to 49 points.
A 25% reduction from the baseline score on the PANSS-N will be considered a significant decrease.
Measured: 12 weeks
Secondary outcomes (6)
Positive symptoms
Positive symptoms are measured with the Positive and negative syndrome scale (PANSS) positive subscale. It consists of seven items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution and hostility. Scale's scoring system ranges from 7 to 49 points. No changes from the baseline PANSS-P score are expected.
Measured: 12 weeks
Mood symptoms
Mood symptoms are assessed with the Calgary depression scale for schizophrenia. Scale's scoring system ranges from 0 to 27 points.
Measured: 12 weeks
Quality of life: Short Form (36) Health Survey
The Short Form (36) Health Survey is a self-applied questionnaire that addresses eight life dimensions: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. It will be used to assess quality of life. As it is a dimensional scale, it does not have a cutoff score.
Measured: 12 weeks
Global functioning
Global assessment of functioning (GAF) is a numeric scale of social, occupational and psychological functioning. Scale's scoring system ranges from 10 to 100 points.
Measured: 12 weeks
Social anxiety
Social anxiety symptoms are measured with Social Interaction Anxiety Scale (SIAS). This is a self applied, twenty items instrument. Scale's scoring system ranges from 0 to 80 points.
Measured: 12 weeks
Adverse effects
Adverse effects are measured with the Simulator Sickness Questionnaire (SSQ). This instrument assesses 16 subjective items and was developed to accommodate symptoms specific to simulator technology. It can be self applied or clinician rated. Participants are asked to assign a score from 0-3 for each of the sixteen items on the SSQ. Total scores can be associated with negligible (\< 5), minimal (5 - 10), significant (10 - 15), concerning (15 - 20) and bad (\>20) symptoms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 May 2022
- Primary completionMay 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Model description
- The study will be a double-blind, randomized controlled trial (RCT). Patients will be divided into two groups. The intervention group will receive a VR experience with a treatment software, while the control group will receive a VR experience without the software. All patients will continue on their current medications
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de la Florida Dra. Eloiza Diaz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javiera Libuy Mena, Hospital de la Florida Dra. Eloiza Diaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588270
- Sponsor's protocol ID
- SA20I0002
- Other IDs
- SA20I0002
- Acronym
- VR-SCHIZO
- Status last verified
- Sep 2024
- First submitted
- 15 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saha S, Chant D, Welham J, McGrath J. A systematic review of the prevalence of schizophrenia. PLoS Med. 2005 May;2(5):e141. doi: 10.1371/journal.pmed.0020141. Epub 2005 May 31.
PubMed 15916472McGrath J, Saha S, Chant D, Welham J. Schizophrenia: a concise overview of incidence, prevalence, and mortality. Epidemiol Rev. 2008;30:67-76. doi: 10.1093/epirev/mxn001. Epub 2008 May 14.
PubMed 18480098Vicente B, Rioseco P, Saldivia S, Kohn R, Torres S. [Chilean study on the prevalence of psychiatric disorders (DSM-III-R/CIDI) (ECPP)]. Rev Med Chil. 2002 May;130(5):527-36. Spanish.
PubMed 12143273Gonzalez-Valderrama A, Jongsma HE, Mena C, Castaneda CP, Nachar R, Undurraga J, Crossley N, Aceituno D, Iruretagoyena B, Gallardo C, Mondaca P, Monje M, Irarrazaval M, Zavala C, Valmaggia L, Kirkbride JB. The incidence of non-affective psychotic disorders in Chile between 2005 and 2018: results from a national register of over 30 000 cases. Psychol Med. 2022 Apr;52(5):914-923. doi: 10.1017/S0033291720002664. Epub 2020 Aug 6.
PubMed 32758314GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.
PubMed 35026139Cloutier M, Aigbogun MS, Guerin A, Nitulescu R, Ramanakumar AV, Kamat SA, DeLucia M, Duffy R, Legacy SN, Henderson C, Francois C, Wu E. The Economic Burden of Schizophrenia in the United States in 2013. J Clin Psychiatry. 2016 Jun;77(6):764-71. doi: 10.4088/JCP.15m10278.
PubMed 27135986Hjorthoj C, Sturup AE, McGrath JJ, Nordentoft M. Years of potential life lost and life expectancy in schizophrenia: a systematic review and meta-analysis. Lancet Psychiatry. 2017 Apr;4(4):295-301. doi: 10.1016/S2215-0366(17)30078-0. Epub 2017 Feb 22.
PubMed 28237639Saha S, Chant D, McGrath J. A systematic review of mortality in schizophrenia: is the differential mortality gap worsening over time? Arch Gen Psychiatry. 2007 Oct;64(10):1123-31. doi: 10.1001/archpsyc.64.10.1123.
PubMed 17909124Avila C, Holloway AC, Hahn MK, Morrison KM, Restivo M, Anglin R, Taylor VH. An Overview of Links Between Obesity and Mental Health. Curr Obes Rep. 2015 Sep;4(3):303-10. doi: 10.1007/s13679-015-0164-9.
PubMed 26627487Harvey PD, Strassnig M. Predicting the severity of everyday functional disability in people with schizophrenia: cognitive deficits, functional capacity, symptoms, and health status. World Psychiatry. 2012 Jun;11(2):73-9. doi: 10.1016/j.wpsyc.2012.05.004.
PubMed 22654932Galderisi S, Rossi A, Rocca P, Bertolino A, Mucci A, Bucci P, Rucci P, Gibertoni D, Aguglia E, Amore M, Bellomo A, Biondi M, Brugnoli R, Dell'Osso L, De Ronchi D, Di Emidio G, Di Giannantonio M, Fagiolini A, Marchesi C, Monteleone P, Oldani L, Pinna F, Roncone R, Sacchetti E, Santonastaso P, Siracusano A, Vita A, Zeppegno P, Maj M; Italian Network For Research on Psychoses. The influence of illness-related variables, personal resources and context-related factors on real-life functioning of people with schizophrenia. World Psychiatry. 2014 Oct;13(3):275-87. doi: 10.1002/wps.20167.
PubMed 25273301Rabinowitz J, Levine SZ, Garibaldi G, Bugarski-Kirola D, Berardo CG, Kapur S. Negative symptoms have greater impact on functioning than positive symptoms in schizophrenia: analysis of CATIE data. Schizophr Res. 2012 May;137(1-3):147-50. doi: 10.1016/j.schres.2012.01.015. Epub 2012 Feb 6.
PubMed 22316568Jauhar S, McKenna PJ, Radua J, Fung E, Salvador R, Laws KR. Cognitive-behavioural therapy for the symptoms of schizophrenia: systematic review and meta-analysis with examination of potential bias. Br J Psychiatry. 2014 Jan;204(1):20-9. doi: 10.1192/bjp.bp.112.116285.
PubMed 24385461McCutcheon RA, Pillinger T, Mizuno Y, Montgomery A, Pandian H, Vano L, Marques TR, Howes OD. The efficacy and heterogeneity of antipsychotic response in schizophrenia: A meta-analysis. Mol Psychiatry. 2021 Apr;26(4):1310-1320. doi: 10.1038/s41380-019-0502-5. Epub 2019 Aug 30.
PubMed 31471576Galderisi S, Mucci A, Buchanan RW, Arango C. Negative symptoms of schizophrenia: new developments and unanswered research questions. Lancet Psychiatry. 2018 Aug;5(8):664-677. doi: 10.1016/S2215-0366(18)30050-6. Epub 2018 Mar 27.
PubMed 29602739
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06588270
- Acronym / sponsor ID
- VR-SCHIZO / SA20I0002
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Virtual reality, Negative symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hospital de la Florida Dra. Eloiza DiazUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
A randomised, controlled, double-blind clinical trial will be carried out to evaluate the effectiveness of a VR assisted treatment for negative symptoms in people with schizophrenia. Patients with a standardised diagnosis of schizophrenia meeting the inclusion criteria will receive 12 weekly sessions of VR assisted therapy plus treatment as usual (TAU). A control group will be exposed to a neutral VR environment plus TAU. The hypothesis is that patients who are treated with active VR assisted therapy will have less negative symptoms as rated by the PANSS-N scale, compared to the control group.
The protocol was approved by the hospital ethics committee of the Servicio de Salud Metropolitano Suroriente. Patients sign an informed consent form, from which they may withdraw at any point during the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a double-blind, randomized controlled trial (RCT). Patients will be divided into two groups. The intervention group will receive a VR experience with a treatment software, while the control group will receive a VR experience without the software. All patients will continue on their current medications
| Arm | Type | Receives |
|---|---|---|
| Virtual reality-based therapy | Experimental | Behavioral: Virtual Reality Therapy for the Negative Symptoms of SchizophreniaThe intervention group will receive a VR experience with a treatment software. The aim is to immerse the patient in an interactive environment that invites him/her to explore and complete goal-directed activities with sensory, visual and/or auditory rewards. The therapy will be delivered with the support of a therapist once per week for 12 consecutive weeks. Each therapy session will last approximately 20 minutes. |
| Sham -VR | Sham comparator | Behavioral: Sham- VRControl group's patients will continue pharmacological and non pharmacological usual treatment. Additionally, these patients will attend to VR sessions without the software created activities for treatment (sham-VR). Sessions will be the same length and quantity as the intervention group's sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of schizophrenia made by the treating psychiatrist and corroborated by a team's psychiatrist under CIE-10 criteria.
- Age between 18 to 65 years-old.
- Outpatient setting,
- Clinical stability defined as no psychiatric hospitalizations in the last 6 months and not currently on queue for psychiatric hospitalization.
- No concomitant active substance abuse disorder, excluding nicotine.
Key exclusion criteria (8 listed)
- Previous diagnosis of learning disability according either to ICD- 10 or clinical history
- Verbal expression difficulties, determined by language or medical causes.
- Deafness and/or blindness.
- Other physical handicaps to use VR devices.
- Predominant positive symptoms, defined as PANNS-C > 0.
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 |
|---|---|---|
| Virtual Reality Therapy for the Negative Symptoms of SchizophreniaVRTNSS is a 12-session therapy using psychological intervention principles. Each therapy session will involve engaging with different VR based tasks where participants can experience different activities. | Behavioural | Virtual reality-based therapy |
| Sham- VRPatients will attend to VR sessions without the software created activities for treatment (sham-VR). | Behavioural | Sham -VR |
Primary outcome
Negative symptoms
Time frame: 12 weeks
The primary outcome will be the difference in the rate of change in negative symptoms at 3 months of follow-up. Negative symptoms are measured with the Positive and negative syndrome scale (PANSS) negative subscale. Scale's scoring system ranges from 7 to 49 points. A 25% reduction from the baseline score on the PANSS-N will be considered a significant decrease.
6 secondary outcomes
Positive symptoms
Time frame: 12 weeks
Mood symptoms
Time frame: 12 weeks
Quality of life: Short Form (36) Health Survey
Time frame: 12 weeks
Global functioning
Time frame: 12 weeks
Social anxiety
Time frame: 12 weeks
Adverse effects
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 15916472Saha S, Chant D, Welham J, McGrath J. A systematic review of the prevalence of schizophrenia. PLoS Med. 2005 May;2(5):e141. doi: 10.1371/journal.pmed.0020141. Epub 2005 May 31.
- Background: PubMed 18480098McGrath J, Saha S, Chant D, Welham J. Schizophrenia: a concise overview of incidence, prevalence, and mortality. Epidemiol Rev. 2008;30:67-76. doi: 10.1093/epirev/mxn001. Epub 2008 May 14.
- Background: PubMed 12143273Vicente B, Rioseco P, Saldivia S, Kohn R, Torres S. [Chilean study on the prevalence of psychiatric disorders (DSM-III-R/CIDI) (ECPP)]. Rev Med Chil. 2002 May;130(5):527-36. Spanish.
- Background: PubMed 32758314Gonzalez-Valderrama A, Jongsma HE, Mena C, Castaneda CP, Nachar R, Undurraga J, Crossley N, Aceituno D, Iruretagoyena B, Gallardo C, Mondaca P, Monje M, Irarrazaval M, Zavala C, Valmaggia L, Kirkbride JB. The incidence of non-affective psychotic disorders in Chile between 2005 and 2018: results from a national register of over 30 000 cases. Psychol Med. 2022 Apr;52(5):914-923. doi: 10.1017/S0033291720002664. Epub 2020 Aug 6.
- Background: PubMed 35026139GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.
- Background: PubMed 27135986Cloutier M, Aigbogun MS, Guerin A, Nitulescu R, Ramanakumar AV, Kamat SA, DeLucia M, Duffy R, Legacy SN, Henderson C, Francois C, Wu E. The Economic Burden of Schizophrenia in the United States in 2013. J Clin Psychiatry. 2016 Jun;77(6):764-71. doi: 10.4088/JCP.15m10278.
- Background: PubMed 28237639Hjorthoj C, Sturup AE, McGrath JJ, Nordentoft M. Years of potential life lost and life expectancy in schizophrenia: a systematic review and meta-analysis. Lancet Psychiatry. 2017 Apr;4(4):295-301. doi: 10.1016/S2215-0366(17)30078-0. Epub 2017 Feb 22.
- Background: PubMed 17909124Saha S, Chant D, McGrath J. A systematic review of mortality in schizophrenia: is the differential mortality gap worsening over time? Arch Gen Psychiatry. 2007 Oct;64(10):1123-31. doi: 10.1001/archpsyc.64.10.1123.
- Background: PubMed 26627487Avila C, Holloway AC, Hahn MK, Morrison KM, Restivo M, Anglin R, Taylor VH. An Overview of Links Between Obesity and Mental Health. Curr Obes Rep. 2015 Sep;4(3):303-10. doi: 10.1007/s13679-015-0164-9.
- Background: PubMed 22654932Harvey PD, Strassnig M. Predicting the severity of everyday functional disability in people with schizophrenia: cognitive deficits, functional capacity, symptoms, and health status. World Psychiatry. 2012 Jun;11(2):73-9. doi: 10.1016/j.wpsyc.2012.05.004.
- Background: PubMed 25273301Galderisi S, Rossi A, Rocca P, Bertolino A, Mucci A, Bucci P, Rucci P, Gibertoni D, Aguglia E, Amore M, Bellomo A, Biondi M, Brugnoli R, Dell'Osso L, De Ronchi D, Di Emidio G, Di Giannantonio M, Fagiolini A, Marchesi C, Monteleone P, Oldani L, Pinna F, Roncone R, Sacchetti E, Santonastaso P, Siracusano A, Vita A, Zeppegno P, Maj M; Italian Network For Research on Psychoses. The influence of illness-related variables, personal resources and context-related factors on real-life functioning of people with schizophrenia. World Psychiatry. 2014 Oct;13(3):275-87. doi: 10.1002/wps.20167.
- Background: PubMed 22316568Rabinowitz J, Levine SZ, Garibaldi G, Bugarski-Kirola D, Berardo CG, Kapur S. Negative symptoms have greater impact on functioning than positive symptoms in schizophrenia: analysis of CATIE data. Schizophr Res. 2012 May;137(1-3):147-50. doi: 10.1016/j.schres.2012.01.015. Epub 2012 Feb 6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Therapy for the Negative Symptoms of Schizophrenia in people with Schizophrenia, run by Hospital de la Florida Dra. Eloiza Diaz at 1 site in Chile.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javiera Libuy, MD (+569654112870, jclibuy@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative symptoms (time frame: 12 weeks). 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 NCT06588270, which also lists 53 linked publications.
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 19 Sep 2024.