PsychosisNCT02430935
A Study of the Effectiveness of Cognitive Adaptation Training in Early Intervention for Psychosis
A study testing Cognitive Adaptation Training and Action Based Cognitive Remediation in people with Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for early intervention as compared against an active control in which Action Based Cognitive Remediation (ABCR) will be applied. Read more about this study
- Who is it for?
- Ages 16 to 29 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Cognitive Adaptation Training and Action Based Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to May 2018
- 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 16 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must be CAMH clients, have an assigned caseworker, be between the ages of 16-34 and have a psychosis such as schizophrenia or schizoaffective disorder.
Who cannot join
- not currently experiencing high level of paranoia.
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for early intervention as compared against an active control in which Action Based Cognitive Remediation (ABCR) will be applied.
Read the detailed description
The proposed project will expand knowledge of the role of compensatory and restorative cognitive interventions for early intervention population individuals with schizophrenia. The investigators will conduct a two arm randomized trial comparing the impacts of CAT and Action Based Cognitive Remediation (ABCR) for individuals with schizophrenia who are under the age of 30. The model would mirror the investigators' preliminary work at CAMH (Kidd et al., 2014) in which there will be 4 months of specialist-delivered treatment followed by 5 months of maintenance by case managers with pre, 4 month, and 9 month evaluations conducted. This study will be among the most rigorous examinations of such interventions to date, would be among the first to examine integrative approaches, and would make a substantial contribution to the early intervention literature.
The questions for the purposes of this project are:
- Is CAT effective among individuals with schizophrenia under the age of 30? and
- Does integrating cognitive remediation with CAT enhance outcomes as compared with CAT alone?
- Conditions
- Psychosis
- Being tested
- Cognitive Adaptation Training, Action Based Cognitive Remediation
- Keywords
- Psychosis, Psychosis NOS, Schizophrenia, Schizoaffective Disorder, Early Intervention
- Medical subject headings
- Psychotic Disorders, Mental Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Adaptation TrainingBehavioural
Cognitive Adaptation Training (CAT) is a manual-driven standardized approach that uses environmental supports to improve multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia. Interventions for each functional deficit are based on two dimensions 1) level of impairment in executive functions (determined by neurocognitive tests) and 2) whether the overt behavior of the individual is characterized more by apathy (poverty of speech/movement/inability to initiate and follow through on behavioral sequences), disinhibition (distractibility/behavior which is highly cue-driven) or a combination of these styles (based on the Frontal Lobe Personality Scale (FLOPS).
Action Based Cognitive RemediationBehavioural
ABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Adaptation Training | Experimental | Cognitive Adaptation Training (CAT) is a standardized approach to the use of environmental supports for improving multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia. Receives: Behavioral: Cognitive Adaptation Training |
| Action Based Cognitive Remediation | Active comparator | ABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment. Receives: Behavioral: Action Based Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adaptive Functioning (SOFAS)
A global level of social and occupational functioning will be obtained using the Social and Occupational Functioning Scale from the DSM-IV (American Psychiatric Association, 2000). The SOFAS rates global functioning on a scale from 0 to 100. The rating does not take into account level of symptomatology.
Measured: Change from baseline to 4 months and 9 months
Change in Adaptive Functioning (SFS)
The Social Functioning Scale (SFS; Birchwood et al., 1990) will be administered. This is a self-report measure that details the frequency and intensity with which the person engages in functional activities. A total score and domain scores for social withdrawal, relationships, social activity, recreational activity, independence (competence), independence (performance) and employment are generated.
Measured: Change from baseline to 4 months and 9 months
change in Adaptive Functioning (MCAS)
Both client and clinician versions of 17-item The Multnomah Community Ability Scale (MCAS, Barker et al., 1994) will be used to assess functionality.
Measured: Change from baseline to 4 months and 9 months
Secondary outcomes (11)
Medication Adherence
Medication adherence will be determined through regular pill counts of currently prescribed psychiatric medications and pharmacy records.
Measured: Throughout the 9 months of participation.
Hospitalization
Hospitalization will be tracked by (i) monitoring of electronic records through the central CAMH database and (ii) the reports of the primary Case Manager. Both frequency and duration of inpatient stays will be documented as will the frequency of emergency room visits.
Measured: Throughout the 9 months of participation.
Change in Goal Attainment (GAS)
Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals that has demonstrated good reliability and validity with severe mental illness populations (Hurn et al., 2006). Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Goals are individualized to the client and assessment of progress are determined through consensus of the clinician and case manager.
Measured: Change from baseline to 4 months and 9 months
Change in Caregiver Burden (IEQ)
Caregiver burden will be measured for the family member involved in implementing CAT using the 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000). This questionnaire, which has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks.
Measured: Change from baseline to 4 months and 9 months
Change in Cognition (WRAT-III)
The Wide Range Achievement Test (WRAT-III) reading subtest (Wilkinson, 1993) will be used to evaluate pre-morbid educational attainment.
Measured: Change from baseline to 4 months and 9 months
Change in Cognition (Trail Making test part A)
The Trail Making test part A (Radford et al., 1978), a test involving using lines to connect numbers, will be used to assess scanning ability and psychomotor speed.
Measured: Change from baseline to 4 months and 9 months
Change in Cognition (Digit Span Subtest of the Weschler Adult Intelligence Scale - III )
Short term memory will be evaluated with the digit span subtest of the Weschler Adult Intelligence Scale - III (The Psychological Corporation, 1997).
Measured: Change from baseline to 4 months and 9 months
Change in Cognition (CVLT)
Verbal learning and memory will be assessed with the California Verbal Learning Test (CVLT -Delis et al., 1987). The CVLT involves the repeated presentation of a word list that determines acquisition ability and retention.
Measured: Change from baseline to 4 months and 9 months
Change in Cognition (Trail Making Test, Part B, and the Wisconsin Card Sorting Test)
Executive functioning will be assessed with the Trail Making Test, Part B, and the Wisconsin Card Sorting Test (WCST - Berg, 1948).
Measured: Change from baseline to 4 months and 9 months
Change in Positive symptoms (BPRS-E)
Positive symptoms will be assessed using the expanded version of the Brief Psychiatric Rating Scale (BPRS-E; Ventura et al., 1993). The BPRS-E is a 24-item scale assessing multiple domains of psychopathology on a series of 7-point scales (1-7). A positive symptom factor score is composed of items assessing hallucinations, unusual thought content, conceptual disorganization and suspiciousness.
Measured: Change from baseline to 4 months and 9 months
Change in Negative symptoms (NSA)
Negative symptoms will be assessed using the Negative Symptom Assessment (NSA; Alphs et al., 1989). The NSA is a 26-item instrument examining negative symptomatology on a series of 7-point scales (0-6). A total negative symptom score is calculated by adding together the scores from the NSA subscales, communication, emotion, motivation, social functioning, and cognition.
Measured: Change from baseline to 4 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Kidd, Centre for Addiction and Mental Health
- Investigators
- Sean Kidd, Principal investigator, Clinician Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430935
- Sponsor's protocol ID
- 03/24/2015
- Status last verified
- Jul 2018
- First submitted
- 8 Apr 2015
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Alphs LD, Summerfelt A, Lann H, Muller RJ. The negative symptom assessment: a new instrument to assess negative symptoms of schizophrenia. Psychopharmacol Bull. 1989;25(2):159-63. No abstract available.
PubMed 2602512BERG EA. A simple objective technique for measuring flexibility in thinking. J Gen Psychol. 1948 Jul;39:15-22. doi: 10.1080/00221309.1948.9918159. No abstract available.
PubMed 18889466Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. doi: 10.1192/bjp.157.6.853.
PubMed 2289094Delis, D., Kramer, J., Kaplan. E., & Ober, B. (1987). California Verbal Learning and Memory Test (Manual). San Antonio, TX: Psychological Corporation.
Draper ML, Stutes DS, Maples NJ, Velligan DI. Cognitive adaptation training for outpatients with schizophrenia. J Clin Psychol. 2009 Aug;65(8):842-53. doi: 10.1002/jclp.20612.
PubMed 19521972Kelland DZ, Lewis RF. The Digit Vigilance Test: reliability, validity, and sensitivity to diazepam. Arch Clin Neuropsychol. 1996;11(4):339-44.
PubMed 14588938Kidd SA, Kaur J, Virdee G, George TP, McKenzie K, Herman Y. Cognitive remediation for individuals with psychosis in a supported education setting: a randomized controlled trial. Schizophr Res. 2014 Aug;157(1-3):90-8. doi: 10.1016/j.schres.2014.05.007. Epub 2014 Jun 2.
PubMed 24893903Kidd SA, Herman Y, Barbic S, Ganguli R, George TP, Hassan S, McKenzie K, Maples N, Velligan D. Testing a modification of cognitive adaptation training: streamlining the model for broader implementation. Schizophr Res. 2014 Jun;156(1):46-50. doi: 10.1016/j.schres.2014.03.026. Epub 2014 Apr 29.
PubMed 24794880Radford LM, Chaney EF, O'Leary MR, O'Leary DE. Screening for cognitive impairment among inpatients. J Clin Psychiatry. 1978 Sep;39(9):712-5.
PubMed 690089The Psychological Corporation. (1997). WAIS-III administration and scoring manual. San Antonio, TX: Psychological Corporation.
Ventura J, Green MF, Shaner A, Liberman RP: Training and quality assurance with the brief psychiatric rating scale: The drift busters. International Journal of Methods in Psychiatric Research 1993; 3:221-24
Wilkinson ,G. (1993). Wide Range Achievement Test 3 (Manual). Wilmington, DE: Wide Range Inc.
Diagnostic and statistical manual of mental disorders (4th ed.). American Psychiatric Association, Washington, DC
Barker S, Barron N, McFarland BH, Bigelow DA. A community ability scale for chronically mentally ill consumers: Part I. Reliability and validity. Community Ment Health J. 1994 Aug;30(4):363-83. doi: 10.1007/BF02207489.
PubMed 7956112
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effectiveness of Cognitive Adaptation Training in Early Intervention for Psychosis
- ClinicalTrials.gov ID
- NCT02430935
- Acronym / sponsor ID
- 03/24/2015
- Conditions
- Psychosis
- Keywords
- Psychosis, Psychosis NOS, Schizophrenia, Schizoaffective Disorder, Early Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for early intervention as compared against an active control in which Action Based Cognitive Remediation (ABCR) will be applied.
Detailed description
The proposed project will expand knowledge of the role of compensatory and restorative cognitive interventions for early intervention population individuals with schizophrenia. The investigators will conduct a two arm randomized trial comparing the impacts of CAT and Action Based Cognitive Remediation (ABCR) for individuals with schizophrenia who are under the age of 30. The model would mirror the investigators' preliminary work at CAMH (Kidd et al., 2014) in which there will be 4 months of specialist-delivered treatment followed by 5 months of maintenance by case managers with pre, 4 month, and 9 month evaluations conducted. This study will be among the most rigorous examinations of such interventions to date, would be among the first to examine integrative approaches, and would make a substantial contribution to the early intervention literature.
The questions for the purposes of this project are:
- Is CAT effective among individuals with schizophrenia under the age of 30? and
- Does integrating cognitive remediation with CAT enhance outcomes as compared with CAT alone?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Adaptation Training | Experimental | Behavioral: Cognitive Adaptation TrainingCognitive Adaptation Training (CAT) is a standardized approach to the use of environmental supports for improving multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia. |
| Action Based Cognitive Remediation | Active comparator | Behavioral: Action Based Cognitive RemediationABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment. |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants must be CAMH clients, have an assigned caseworker, be between the ages of 16-34 and have a psychosis such as schizophrenia or schizoaffective disorder.
Key exclusion criteria (1 listed)
- not currently experiencing high level of paranoia.
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 |
|---|---|---|
| Cognitive Adaptation TrainingCognitive Adaptation Training (CAT) is a manual-driven standardized approach that uses environmental supports to improve multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia. Interventions for each functional deficit are based on two dimensions 1) level of impairment in executive functions (determined by neurocognitive tests) and 2) whether the overt behavior of the individual is characterized more by apathy (poverty of speech/movement/inability to initiate and follow through on behavioral sequences), disinhibition (distractibility/behavior which is highly cue-driven) or a combination of these styles (based on the Frontal Lobe Personality Scale (FLOPS). | Behavioural | Cognitive Adaptation Training |
| Action Based Cognitive RemediationABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment. | Behavioural | Action Based Cognitive Remediation |
Primary outcome
Change in Adaptive Functioning (SOFAS)
Time frame: Change from baseline to 4 months and 9 months
A global level of social and occupational functioning will be obtained using the Social and Occupational Functioning Scale from the DSM-IV (American Psychiatric Association, 2000). The SOFAS rates global functioning on a scale from 0 to 100. The rating does not take into account level of symptomatology.
Change in Adaptive Functioning (SFS)
Time frame: Change from baseline to 4 months and 9 months
The Social Functioning Scale (SFS; Birchwood et al., 1990) will be administered. This is a self-report measure that details the frequency and intensity with which the person engages in functional activities. A total score and domain scores for social withdrawal, relationships, social activity, recreational activity, independence (competence), independence (performance) and employment are generated.
change in Adaptive Functioning (MCAS)
Time frame: Change from baseline to 4 months and 9 months
Both client and clinician versions of 17-item The Multnomah Community Ability Scale (MCAS, Barker et al., 1994) will be used to assess functionality.
11 secondary outcomes
Medication Adherence
Time frame: Throughout the 9 months of participation.
Hospitalization
Time frame: Throughout the 9 months of participation.
Change in Goal Attainment (GAS)
Time frame: Change from baseline to 4 months and 9 months
Change in Caregiver Burden (IEQ)
Time frame: Change from baseline to 4 months and 9 months
Change in Cognition (WRAT-III)
Time frame: Change from baseline to 4 months and 9 months
Change in Cognition (Trail Making test part A)
Time frame: Change from baseline to 4 months and 9 months
Change in Cognition (Digit Span Subtest of the Weschler Adult Intelligence Scale - III )
Time frame: Change from baseline to 4 months and 9 months
Change in Cognition (CVLT)
Time frame: Change from baseline to 4 months and 9 months
Change in Cognition (Trail Making Test, Part B, and the Wisconsin Card Sorting Test)
Time frame: Change from baseline to 4 months and 9 months
Change in Positive symptoms (BPRS-E)
Time frame: Change from baseline to 4 months and 9 months
Change in Negative symptoms (NSA)
Time frame: Change from baseline to 4 months and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Background: PubMed 2602512Alphs LD, Summerfelt A, Lann H, Muller RJ. The negative symptom assessment: a new instrument to assess negative symptoms of schizophrenia. Psychopharmacol Bull. 1989;25(2):159-63. No abstract available.
- Background: PubMed 18889466BERG EA. A simple objective technique for measuring flexibility in thinking. J Gen Psychol. 1948 Jul;39:15-22. doi: 10.1080/00221309.1948.9918159. No abstract available.
- Background: PubMed 2289094Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. doi: 10.1192/bjp.157.6.853.
- BackgroundDelis, D., Kramer, J., Kaplan. E., & Ober, B. (1987). California Verbal Learning and Memory Test (Manual). San Antonio, TX: Psychological Corporation.
- Background: PubMed 19521972Draper ML, Stutes DS, Maples NJ, Velligan DI. Cognitive adaptation training for outpatients with schizophrenia. J Clin Psychol. 2009 Aug;65(8):842-53. doi: 10.1002/jclp.20612.
- Background: PubMed 14588938Kelland DZ, Lewis RF. The Digit Vigilance Test: reliability, validity, and sensitivity to diazepam. Arch Clin Neuropsychol. 1996;11(4):339-44.
- Background: PubMed 24893903Kidd SA, Kaur J, Virdee G, George TP, McKenzie K, Herman Y. Cognitive remediation for individuals with psychosis in a supported education setting: a randomized controlled trial. Schizophr Res. 2014 Aug;157(1-3):90-8. doi: 10.1016/j.schres.2014.05.007. Epub 2014 Jun 2.
- Background: PubMed 24794880Kidd SA, Herman Y, Barbic S, Ganguli R, George TP, Hassan S, McKenzie K, Maples N, Velligan D. Testing a modification of cognitive adaptation training: streamlining the model for broader implementation. Schizophr Res. 2014 Jun;156(1):46-50. doi: 10.1016/j.schres.2014.03.026. Epub 2014 Apr 29.
- Background: PubMed 690089Radford LM, Chaney EF, O'Leary MR, O'Leary DE. Screening for cognitive impairment among inpatients. J Clin Psychiatry. 1978 Sep;39(9):712-5.
- BackgroundThe Psychological Corporation. (1997). WAIS-III administration and scoring manual. San Antonio, TX: Psychological Corporation.
- BackgroundVentura J, Green MF, Shaner A, Liberman RP: Training and quality assurance with the brief psychiatric rating scale: The drift busters. International Journal of Methods in Psychiatric Research 1993; 3:221-24
- BackgroundWilkinson ,G. (1993). Wide Range Achievement Test 3 (Manual). Wilmington, DE: Wide Range Inc.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addictions teaching hospital.Link provided by the sponsor.
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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.
Sean Kidd principal investigator
Clinician Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Adaptation Training and Action Based Cognitive Remediation in people with Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 1 inclusion and 1 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 23 Jul 2018. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adaptive Functioning (SOFAS) (time frame: Change from baseline to 4 months and 9 months). The study lists 3 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 NCT02430935, which also lists 14 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 23 Jul 2018.