SchizophreniaPhase 2NCT03751280
Study of Efficacy of PEAR-004 in Schizophrenia
A Phase 2 study testing PEAR-004 in people with Schizophrenia, run by Novartis Pharmaceuticals at 6 sites in United States.
Trial summary
The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- PEAR-004
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Dec 2018to 26 Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed informed consent must be obtained prior to participation in the study.
- Healthy male and female subjects 18 to 65 years of age, inclusive, and in good health as determined by medical history, physical examination, and vital signs at screening
- SCID-based DSM-5 diagnosis of schizophrenia and a total PANSS score > 60
- Proficient in English at 5th grade reading level or higher, in the judgement of the investigator
- Capable of using a mobile device (compatible with PEAR-004) and using common applications, in the judgement of the investigator
Who cannot join
- Major change in primary antipsychotic medication in the prior 4 weeks before screening (e.g., switching to a new agent or a dose adjustment within two weeks of randomization)
- Planning to move out of the geographic area within 3 months
- Unable to use English to participate in the consent process, the interventions or assessments
- Inability to comply with study procedures, due to severe medical conditions or otherwise
- Meet DSM-5 diagnosis for a current episode of major depression, mania, or hypomania in the past month
- Meet DSM-5 diagnosis for a current moderate or severe alcohol or cannabis use disorder in the past 2 months
Show all 9Show fewer
- Meet DSM-5 diagnosis for a current substance use disorder (other than alcohol or cannabis) in the past 2 months
- Considered high risk for suicidal behavior based on ISST-Plus score at screening, or in the judgement of the investigator
- Previously participated in a clinical study involving PEAR-004
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Novartis Investigative Site
Albuquerque, New Mexico, 87102
Novartis Investigative Site
Garden Grove, California, 92845
Novartis Investigative Site
Grand Rapids, Michigan, 49548
Novartis Investigative Site
Maitland, Florida, 32751
Novartis Investigative Site
Oakland, California, 94607
Novartis Investigative Site
Torrance, California, 90502
About this study
Official title: A Randomized, Sham-Controlled Study of PEAR-004 as an Adjunct to Standard-of-care Treatment for Schizophrenia
The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).
The overall rationale for the study was to assess the first prescription digital therapeutic (PDT) in schizophrenia using a form of proven psychosocial intervention, cognitive behavioral therapy (CBT), to supplement standard of care with antipsychotic medications.
Read the detailed description
This was a randomized, sham-controlled, rater-blinded, parallel group trial. Overall, 112 subjects were randomized 1:1 in to the following groups:
- Group A: Clinician-directed pharmacotherapy + PEAR-004
- Group B: Clinician-directed pharmacotherapy + sham app An up to 28-day screening period included standard screening assessments as defined in the assessment schedule. Eligible subjects were randomized on Day 1 into one of the treatment groups.
Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for schizophrenia, including pharmacotherapy. Subjects in Group A used PEAR 004 and subjects in Group B used a sham for a period of 12 weeks. Subjects returned to the clinic for outpatient visits at Week 4 (day 29), Week 8 (day 57), and Week 12 (day 85). At each visit, standard assessments were performed according to the assessment schedule, including PANSS, ISST-Plus, CGI, BMQ, MAP-SR, WHOQOL-BREF, BDI-II, ISI, and adverse events (AEs). A final follow-up visit was performed at Week 16 (day 115),
- Conditions
- Schizophrenia
- Being tested
- PEAR-004, Sham
- Keywords
- Schizophrenia, Digital Therapeutic, CBT, smartphone app, mental disorder, psychosis, acute psychotic reaction, chronic psychosis, failure to recognize what is real, false beliefs, unclear thinking,, confused thinking, auditory hallucinations, paranoia, reduced social engagement, reduced emotional expression
- Medical subject headings
- Schizophrenia, Mental Disorders, Psychotic Disorders, Hallucinations, Paranoid Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAR-004Device
PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.
ShamDevice
PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.
| Study group | Role | What they receive |
|---|---|---|
| PEAR-004 | Experimental | Eligible participants were able to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life. Receives: Device: PEAR-004 |
| Sham | Sham comparator | Eligible participants were able to access a sham control downloaded on a mobile device (iOS and Android based) as needed to receive notifications prompting the participant to open the sham app, which displayed a prescription timer for the remaining duration of app availability. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
Measured: Baseline, Day 29, Day 57, Day 85
Percent of Dropout
Dropout rate to evaluate retention to assigned study treatment
Measured: Day 115
Secondary outcomes (12)
Change From Baseline in the Positive PANSS Score
The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity.
Measured: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the General Psychopathology PANSS Score
The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity.
Measured: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the Negative PANSS Score
The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity.
Measured: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the Motivation and Pleasure Self-report (MAP-SR) Score
The MAP-SR is a 15-item self-report measure that provides a total score index of current motivation/pleasure negative symptoms. Responses are given on a 5-point scale where 0 = no pleasure or motivation and 4 = extreme pleasure or motivation. Total scores range from 0 to 60 and higher scores indicate greater motivation and pleasure during everyday activities.
Measured: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the World Health Organization Quality of Life (WHOQOL-BREF) Scale
The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items) (Domain 1), psychological health (6 items) (Domian 2), social relationships (3 items) (Domain 3), and environmental health (8 items) (Domain 4); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life).
Measured: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the Beck Depression Inventory, Second Ed. (BDI-II) Total Score
Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression.
Measured: Baseline, Day 29, Day 57, Day 85
Percentage Change From Baseline in Total PANSS Score (Within Assigned Treatment Group)
The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
Measured: Baseline, Day 29, Day 57, Day 85
Percentage of Responders as Assessed by the Brief Medication Questionnaire (BMQ)
The Brief Medication Questionnaire (BMQ) collects information about current schizophrenia medication use.
Measured: Day 29, Day 57, and Day 85
Percentage of Responders as Assessed by the Total PANSS Score
A Response is defined as a reduction of at least 20% at day 85 or last visit in total PANSS score relative to Baseline.
Measured: Day 85
Number of Patients With Adverse Events
Adverse events, serious adverse events, and adverse events leading to discontinuation throughout the study
Measured: Day 115
Number of Patients With Vital Sign Measurements
Vital signs at baseline, day 85 or last visit
Measured: Day 85
InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) Score
InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) score. Semi-structured interview to assess severity of suicidal ideation and behavior Part I: collects information on 7 days prior to visit; 13 items scored 0 (min) to 2 (max) for suicidality, with a higher score representing a worse outcome Part II: collects information on suicidal behavior since last visit, with nominal categories Yes / No / Unknown (NA) Part III: global rating of status at time of interview; scored 0 (min) to 5 (max) for suicidality, with a higher score representing a worse outcome.
Please note that only part III score (severity of suicidal risk) was summarized and reported.
Measured: Baseline, Day 29, 57, 85, and 115
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start10 Dec 2018
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751280
- Sponsor's protocol ID
- CPEA001A12201
- Status last verified
- Oct 2020
- First submitted
- 8 Nov 2018
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Ghaemi SN, Sverdlov O, van Dam J, Campellone T, Gerwien R. A Smartphone-Based Intervention as an Adjunct to Standard-of-Care Treatment for Schizophrenia: Randomized Controlled Trial. JMIR Form Res. 2022 Mar 28;6(3):e29154. doi: 10.2196/29154.
PubMed 35343910
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-Controlled Study of PEAR-004 as an Adjunct to Standard-of-care Treatment for Schizophrenia
- ClinicalTrials.gov ID
- NCT03751280
- Acronym / sponsor ID
- CPEA001A12201
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Digital Therapeutic, CBT, smartphone app, mental disorder, psychosis, acute psychotic reaction, chronic psychosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 23 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).
The overall rationale for the study was to assess the first prescription digital therapeutic (PDT) in schizophrenia using a form of proven psychosocial intervention, cognitive behavioral therapy (CBT), to supplement standard of care with antipsychotic medications.
Detailed description
This was a randomized, sham-controlled, rater-blinded, parallel group trial. Overall, 112 subjects were randomized 1:1 in to the following groups:
- Group A: Clinician-directed pharmacotherapy + PEAR-004
- Group B: Clinician-directed pharmacotherapy + sham app An up to 28-day screening period included standard screening assessments as defined in the assessment schedule. Eligible subjects were randomized on Day 1 into one of the treatment groups.
Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for schizophrenia, including pharmacotherapy. Subjects in Group A used PEAR 004 and subjects in Group B used a sham for a period of 12 weeks. Subjects returned to the clinic for outpatient visits at Week 4 (day 29), Week 8 (day 57), and Week 12 (day 85). At each visit, standard assessments were performed according to the assessment schedule, including PANSS, ISST-Plus, CGI, BMQ, MAP-SR, WHOQOL-BREF, BDI-II, ISI, and adverse events (AEs). A final follow-up visit was performed at Week 16 (day 115),
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEAR-004 | Experimental | Device: PEAR-004Eligible participants were able to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life. |
| Sham | Sham comparator | Device: ShamEligible participants were able to access a sham control downloaded on a mobile device (iOS and Android based) as needed to receive notifications prompting the participant to open the sham app, which displayed a prescription timer for the remaining duration of app availability. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Healthy male and female subjects 18 to 65 years of age, inclusive, and in good health as determined by medical history, physical examination, and vital signs at screening
- SCID-based DSM-5 diagnosis of schizophrenia and a total PANSS score > 60
- Proficient in English at 5th grade reading level or higher, in the judgement of the investigator
- Capable of using a mobile device (compatible with PEAR-004) and using common applications, in the judgement of the investigator
Key exclusion criteria (9 listed)
- Major change in primary antipsychotic medication in the prior 4 weeks before screening (e.g., switching to a new agent or a dose adjustment within two weeks of randomization)
- Planning to move out of the geographic area within 3 months
- Unable to use English to participate in the consent process, the interventions or assessments
- Inability to comply with study procedures, due to severe medical conditions or otherwise
- Meet DSM-5 diagnosis for a current episode of major depression, mania, or hypomania in the past month
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 |
|---|---|---|
| PEAR-004PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable. | Device | PEAR-004 |
| ShamPEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable. | Device | Sham |
Primary outcome
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
Time frame: Baseline, Day 29, Day 57, Day 85
The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
Percent of Dropout
Time frame: Day 115
Dropout rate to evaluate retention to assigned study treatment
12 secondary outcomes
Change From Baseline in the Positive PANSS Score
Time frame: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the General Psychopathology PANSS Score
Time frame: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the Negative PANSS Score
Time frame: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the Motivation and Pleasure Self-report (MAP-SR) Score
Time frame: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the World Health Organization Quality of Life (WHOQOL-BREF) Scale
Time frame: Baseline, Day 29, Day 57, Day 85
Change From Baseline in the Beck Depression Inventory, Second Ed. (BDI-II) Total Score
Time frame: Baseline, Day 29, Day 57, Day 85
Percentage Change From Baseline in Total PANSS Score (Within Assigned Treatment Group)
Time frame: Baseline, Day 29, Day 57, Day 85
Percentage of Responders as Assessed by the Brief Medication Questionnaire (BMQ)
Time frame: Day 29, Day 57, and Day 85
Percentage of Responders as Assessed by the Total PANSS Score
Time frame: Day 85
Number of Patients With Adverse Events
Time frame: Day 115
Number of Patients With Vital Sign Measurements
Time frame: Day 85
InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) Score
Time frame: Baseline, Day 29, 57, 85, and 115
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35343910Ghaemi SN, Sverdlov O, van Dam J, Campellone T, Gerwien R. A Smartphone-Based Intervention as an Adjunct to Standard-of-Care Treatment for Schizophrenia: Randomized Controlled Trial. JMIR Form Res. 2022 Mar 28;6(3):e29154. doi: 10.2196/29154.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEAR-004 in people with Schizophrenia, run by Novartis Pharmaceuticals at 6 sites in United States.
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 9 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score (time frame: Baseline, Day 29, Day 57, Day 85). The study lists 2 primary outcomes in all. 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 NCT03751280, 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 5 Jan 2021.