DepressionPhase 2NCT02011438
Coping With Adolescent Peer Victimization and Reducing Anxious/Depressed Symptoms
A Phase 2 study testing UTalk in people with Depression and Social Anxiety, run by University of Miami at 1 site in United States.
Trial summary
Among adolescents, SAD and depression are prevalent, highly comorbid, and can be chronic and impairing. Interpersonal peer victimization (IPV) is a key stressor that contributes to both social anxiety and depression in adolescents; it includes relational (e.g., social exclusion) and reputational (e.g., spreading… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression, Social Anxiety
- What is being tested?
- UTalk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2015
- Phase
- Phase 2
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female adolescents, ages 13-18 years (inclusive) and in grades 9, 10, or 11.
- Participants must be sufficiently fluent in English (by their own self-report) to complete measures and intervention programs in this language.
- Participants must report elevated levels of relational PV and/or reputational PV on screening measures (R-PEQ); i.e., adolescents must obtain a total score > or = to 6 on the relational and/or reputational subscales of the R-PEQ.
- Participants must report symptoms of social anxiety and/or depression that exceed clinical cutoffs on the Social Anxiety Scale for Adolescents (SAS-A > or = to 50) or the Center for Epidemiologic Studies-Depression Scale (CES-D > or = to 16).
Who cannot join
- Enrollment in special education services (e.g., for learning disabilities, mental retardation, pervasive developmental disorder).
- Adolescents must not exceed clinical cutoffs (t score > 63) on the Aggression Subscale of the Youth Self Report (YSR).
- Adolescents must not report elevated levels (score >6) on the overt peer victimization scale of the R-PEQ.
- Adolescents must not currently meet diagnostic criteria for a social anxiety or depressive disorder as determined by the Anxiety Disorders Schedule for Children (ADIS-IV-C).
- Adolescents must not currently meet criteria for PTSD, bipolar disorder, psychosis, or an eating, substance use, or conduct disorder on the ADIS-IV-C.
- Adolescents must not endorse active suicidal items on the Columbia Suicide Severity Rating Scale (C-SSRS).
- Adolescents must not be currently receiving treatment for social anxiety or depressive disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Among adolescents, SAD and depression are prevalent, highly comorbid, and can be chronic and impairing. Interpersonal peer victimization (IPV) is a key stressor that contributes to both social anxiety and depression in adolescents; it includes relational (e.g., social exclusion) and reputational (e.g., spreading rumors) forms of peer victimization. Currently, there are no preventive interventions for adolescent SAD. Also, effective preventive interventions for adolescents have not yet integrated a focus on both social anxiety and depression or targeted specific peer risk factors. Interventions for depression and for bullying have not addressed IPV, which is less observable than overt victimization (e.g., threats, physical acts).
Thus, the Peers Emotions and Relationships (PEERS/UTalk) intervention, will take an integrated approach to reducing risk for SAD and depression by modifying and adapting an evidence-based intervention for depression, Interpersonal Psychotherapy- Adolescents Skills Training (IPT-AST), that focuses on improving interpersonal skills and managing conflict. We will add a) elements of anxiety-based treatments (e.g., exposures) and b) strategies for handling challenging peer experiences. PEERS/UTalk will have a positive focus and will target adolescents who report elevated symptoms of social anxiety and/or depression and high levels of IPV.
Read more
Following are the aims and hypotheses of the Pilot-Randomized Controlled Trial:
Aim: Evaluate PEERS/UTalk. We will screen adolescents and conduct a pilot randomized trial of PEERS (U Talk) versus an Education/Support (ES) condition with up to 60 "high-risk" adolescents.
Hypothesis 1: Both PEERS/UTalk and ES conditions will demonstrate: (a) feasibility via rates of participation and study completion, (b) intervention credibility via adolescents' ratings of acceptability and satisfaction, and (c) high rates of clinician fidelity to the respective manuals.
Hypothesis 2: Adolescents randomized to PEERS/UTalk will show improvements in primary outcomes (less IPV, fewer symptoms of social anxiety and depression, improved clinician ratings) relative to those in the ES condition.
Hypothesis 3: The benefits of PEERS/UTalk over ES will be apparent on the secondary outcomes of increased quality of close friendships, increased peer support.
Exploratory Aims: We will examine: (1) the durability and persistence of PEERS/UTalk intervention effects versus ES on primary outcomes at 6-month follow-up and (2) potential moderators of response to the PEERS/UTalk intervention, recognizing that there are power limitations in doing so.
Read the detailed description
Participants in the Pilot-Randomized Controlled Trial (P-RCT) will be provided with PEERS/UTalk or an Education/Support (ES) control condition, and will receive up to 3 individual and up to 10 group sessions of either. Clinicians will be clinical postdoctoral trainee or doctoral students in clinical psychology with specialized training in evidence-based treatments for youth and experience working with child populations; all clinicians will receive intensive training on the PEERS/UTalk intervention prior to the P-RCT. The research-specific intervention is conceptualized as a preventive intervention, with the possibility of altering the length of the program as needed. The intent is to develop PEERS/UTalk so that it fits within a 60-90 minute period that meets about once a week, during one school semester, or could potentially be conducted as an after-school "club." As is typical of adolescent school-based prevention programs, the groups will be co-ed.
The PEERS/UTalk intervention will consist of the following: The first 2 sessions will be conducted individually, during school, and be modeled on procedures used in Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST), which are further modified to address issues of social anxiety and of IPV. The first 2 sessions are about 45-60 minutes long; a clinician meets with each adolescent to assess PV experiences and socially anxious and depressive symptoms, provides a framework for the group, and conducts an abbreviated interpersonal inventory. The interpersonal inventory is a clinical interview in which the clinician and adolescent review significant peer and other relationships looking for strengths as well as problems and patterns of communication and problem-solving; we have adapted this interview to incorporate IPV experiences and how they influence the adolescent's feelings of social anxiety or depressive symptoms. Together the adolescent and clinician identify interpersonal goals for the group. An inventory of IPV experiences that are challenging for adolescents will also be obtained. The next sessions (up to 10) will be group-sessions (up to 8 adolescents per group) and will incorporate key elements of IPT-AST (modified to integrate strategies for social anxiety, taken from the Unified Protocol for the Treatment of Emotional Disorders in Youth [UP-Y]); these treatment elements will be adapted to include examples of IPV experiences and strategies for handling them. We plan to build on the IPT-AST intervention model because of its focus on improving interpersonal relations and enhancing social skills and supportive relationships. However, we also plan to incorporate strategies from the UP-Y to help teens manage social anxiety; and for all sessions we will cover both social anxiety and depressive feelings and adjust the examples, exercises, and homework assignments so that they incorporate strategies for handling IPV experiences. We also will review the Miami-Dade County Public Schools bullying policy so adolescents know how to handle more serious events, should they arise. Specifically, the first group session will educate members about the symptoms of social anxiety and depression, outline interpersonal problem areas and IPV experiences, and discuss the relationship between feelings and interpersonal interactions. During session 2, discussion and activities help adolescents understand the impact of their words and actions on others, and the feelings that result from a given interaction, including IPV experiences. In session 3, adolescents are introduced to different communication and interpersonal strategies (using "I feel statements", finding the right time to have a conversation) and practice these skills by role-playing hypothetical situations, including ones that involve IPV (e.g., social exclusion, handling an embarrassing situation). In sessions 4-6, group members apply the interpersonal strategies to different relationships in their lives, particularly peer relationships that are linked to IPV experiences and to socially anxious and depressive symptoms. The group also discusses how these techniques can help the adolescents develop new relationships. Adolescents try these techniques outside of group and report back about how the interactions went. Session 7 is devoted to practicing exposure to social situations that are associated with uncomfortable feelings, particularly those occurring in an interpersonal context. Adolescents learn about positive friendship qualities and discuss how to identify these characteristics in others. In session 8, adolescents discuss peer and cyber victimization, as well as how to handle challenging peer situations. During group sessions 9-10, the group reviews the strategies learned and changes that have occurred in the adolescents' relationships and symptoms. Group members are encouraged to continue the interpersonal work on their own.
- Conditions
- Depression, Social Anxiety
- Being tested
- UTalk
- Keywords
- Social Anxiety, Prevention, Peer Relations, Depression, Adolescent, High School, Interpersonal, Peer Victimization
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UTalkBehavioural
Prevention intervention delivered in group format adapted from IPT-AST, for adolescents who experience peer victimization and who are at risk for developing social anxiety and depression.
| Study group | Role | What they receive |
|---|---|---|
| UTalk Intervention | Experimental | Active preventative intervention condition. Receives: Behavioral: UTalk |
| Control | No intervention | Education/Support Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorder Interview Schedule- Children (ADIS-C)
Measured: Baseline, Change from baseline in Clinician Severity Rating at 12 weeks and at 6 month follow up for Social Anxiety Disorder and Major Depressive Disorder
Clinicians Global Impression Scale (Severity and Improvement)
Measured: Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Revised Peer Experiences Questionnaire (subscales for Relational and Reputational PV)
Measured: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Secondary outcomes (6)
Social Anxiety Scale for Adolescents
Measured: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Centers for Epidemiological Studies Depression Scale
Measured: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Perceived Support Scale- Friends and Family
Measured: Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Cyber Peer Experiences Questionnaire
Measured: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Revised Peer Experiences Questionnaire
Measured: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Health Behaviors
Measured: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Annette La Greca, PhD, University of Miami
- Investigators
- Annette M La Greca, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011438
- Sponsor's protocol ID
- 1R34MH095959-01A1
- Status last verified
- Dec 2015
- First submitted
- 7 Jun 2013
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping With Adolescent Peer Victimization and Reducing Anxious/Depressed Symptoms
- ClinicalTrials.gov ID
- NCT02011438
- Acronym / sponsor ID
- 1R34MH095959-01A1
- Conditions
- Depression, Social Anxiety
- Keywords
- Social Anxiety, Prevention, Peer Relations, Depression, Adolescent, High School, Interpersonal, Peer Victimization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- Jun 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Dec 2013 (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.
Among adolescents, SAD and depression are prevalent, highly comorbid, and can be chronic and impairing. Interpersonal peer victimization (IPV) is a key stressor that contributes to both social anxiety and depression in adolescents; it includes relational (e.g., social exclusion) and reputational (e.g., spreading rumors) forms of peer victimization. Currently, there are no preventive interventions for adolescent SAD. Also, effective preventive interventions for adolescents have not yet integrated a focus on both social anxiety and depression or targeted specific peer risk factors. Interventions for depression and for bullying have not addressed IPV, which is less observable than overt victimization (e.g., threats, physical acts).
Thus, the Peers Emotions and Relationships (PEERS/UTalk) intervention, will take an integrated approach to reducing risk for SAD and depression by modifying and adapting an evidence-based intervention for depression, Interpersonal Psychotherapy- Adolescents Skills Training (IPT-AST), that focuses on improving interpersonal skills and managing conflict. We will add a) elements of anxiety-based treatments (e.g., exposures) and b) strategies for handling challenging peer experiences. PEERS/UTalk will have a positive focus and will target adolescents who report elevated symptoms of social anxiety and/or depression and high levels of IPV.
Following are the aims and hypotheses of the Pilot-Randomized Controlled Trial:
Aim: Evaluate PEERS/UTalk. We will screen adolescents and conduct a pilot randomized trial of PEERS (U Talk) versus an Education/Support (ES) condition with up to 60 "high-risk" adolescents.
Hypothesis 1: Both PEERS/UTalk and ES conditions will demonstrate: (a) feasibility via rates of participation and study completion, (b) intervention credibility via adolescents' ratings of acceptability and satisfaction, and (c) high rates of clinician fidelity to the respective manuals.
Hypothesis 2: Adolescents randomized to PEERS/UTalk will show improvements in primary outcomes (less IPV, fewer symptoms of social anxiety and depression, improved clinician ratings) relative to those in the ES condition.
Hypothesis 3: The benefits of PEERS/UTalk over ES will be apparent on the secondary outcomes of increased quality of close friendships, increased peer support.
Exploratory Aims: We will examine: (1) the durability and persistence of PEERS/UTalk intervention effects versus ES on primary outcomes at 6-month follow-up and (2) potential moderators of response to the PEERS/UTalk intervention, recognizing that there are power limitations in doing so.
Detailed description
Participants in the Pilot-Randomized Controlled Trial (P-RCT) will be provided with PEERS/UTalk or an Education/Support (ES) control condition, and will receive up to 3 individual and up to 10 group sessions of either. Clinicians will be clinical postdoctoral trainee or doctoral students in clinical psychology with specialized training in evidence-based treatments for youth and experience working with child populations; all clinicians will receive intensive training on the PEERS/UTalk intervention prior to the P-RCT. The research-specific intervention is conceptualized as a preventive intervention, with the possibility of altering the length of the program as needed. The intent is to develop PEERS/UTalk so that it fits within a 60-90 minute period that meets about once a week, during one school semester, or could potentially be conducted as an after-school "club." As is typical of adolescent school-based prevention programs, the groups will be co-ed.
The PEERS/UTalk intervention will consist of the following: The first 2 sessions will be conducted individually, during school, and be modeled on procedures used in Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST), which are further modified to address issues of social anxiety and of IPV. The first 2 sessions are about 45-60 minutes long; a clinician meets with each adolescent to assess PV experiences and socially anxious and depressive symptoms, provides a framework for the group, and conducts an abbreviated interpersonal inventory. The interpersonal inventory is a clinical interview in which the clinician and adolescent review significant peer and other relationships looking for strengths as well as problems and patterns of communication and problem-solving; we have adapted this interview to incorporate IPV experiences and how they influence the adolescent's feelings of social anxiety or depressive symptoms. Together the adolescent and clinician identify interpersonal goals for the group. An inventory of IPV experiences that are challenging for adolescents will also be obtained. The next sessions (up to 10) will be group-sessions (up to 8 adolescents per group) and will incorporate key elements of IPT-AST (modified to integrate strategies for social anxiety, taken from the Unified Protocol for the Treatment of Emotional Disorders in Youth [UP-Y]); these treatment elements will be adapted to include examples of IPV experiences and strategies for handling them. We plan to build on the IPT-AST intervention model because of its focus on improving interpersonal relations and enhancing social skills and supportive relationships. However, we also plan to incorporate strategies from the UP-Y to help teens manage social anxiety; and for all sessions we will cover both social anxiety and depressive feelings and adjust the examples, exercises, and homework assignments so that they incorporate strategies for handling IPV experiences. We also will review the Miami-Dade County Public Schools bullying policy so adolescents know how to handle more serious events, should they arise. Specifically, the first group session will educate members about the symptoms of social anxiety and depression, outline interpersonal problem areas and IPV experiences, and discuss the relationship between feelings and interpersonal interactions. During session 2, discussion and activities help adolescents understand the impact of their words and actions on others, and the feelings that result from a given interaction, including IPV experiences. In session 3, adolescents are introduced to different communication and interpersonal strategies (using "I feel statements", finding the right time to have a conversation) and practice these skills by role-playing hypothetical situations, including ones that involve IPV (e.g., social exclusion, handling an embarrassing situation). In sessions 4-6, group members apply the interpersonal strategies to different relationships in their lives, particularly peer relationships that are linked to IPV experiences and to socially anxious and depressive symptoms. The group also discusses how these techniques can help the adolescents develop new relationships. Adolescents try these techniques outside of group and report back about how the interactions went. Session 7 is devoted to practicing exposure to social situations that are associated with uncomfortable feelings, particularly those occurring in an interpersonal context. Adolescents learn about positive friendship qualities and discuss how to identify these characteristics in others. In session 8, adolescents discuss peer and cyber victimization, as well as how to handle challenging peer situations. During group sessions 9-10, the group reviews the strategies learned and changes that have occurred in the adolescents' relationships and symptoms. Group members are encouraged to continue the interpersonal work on their own.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UTalk Intervention | Experimental | Behavioral: UTalkActive preventative intervention condition. |
| Control | No intervention | –Education/Support Condition |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female adolescents, ages 13-18 years (inclusive) and in grades 9, 10, or 11.
- Participants must be sufficiently fluent in English (by their own self-report) to complete measures and intervention programs in this language.
- Participants must report elevated levels of relational PV and/or reputational PV on screening measures (R-PEQ); i.e., adolescents must obtain a total score > or = to 6 on the relational and/or reputational subscales of the R-PEQ.
- Participants must report symptoms of social anxiety and/or depression that exceed clinical cutoffs on the Social Anxiety Scale for Adolescents (SAS-A > or = to 50) or the Center for Epidemiologic Studies-Depression Scale (CES-D > or = to 16).
Key exclusion criteria (7 listed)
- Enrollment in special education services (e.g., for learning disabilities, mental retardation, pervasive developmental disorder).
- Adolescents must not exceed clinical cutoffs (t score > 63) on the Aggression Subscale of the Youth Self Report (YSR).
- Adolescents must not report elevated levels (score >6) on the overt peer victimization scale of the R-PEQ.
- Adolescents must not currently meet diagnostic criteria for a social anxiety or depressive disorder as determined by the Anxiety Disorders Schedule for Children (ADIS-IV-C).
- Adolescents must not currently meet criteria for PTSD, bipolar disorder, psychosis, or an eating, substance use, or conduct disorder on the ADIS-IV-C.
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 |
|---|---|---|
| UTalkPrevention intervention delivered in group format adapted from IPT-AST, for adolescents who experience peer victimization and who are at risk for developing social anxiety and depression. | Behavioural | UTalk Intervention |
Primary outcome
Anxiety Disorder Interview Schedule- Children (ADIS-C)
Time frame: Baseline, Change from baseline in Clinician Severity Rating at 12 weeks and at 6 month follow up for Social Anxiety Disorder and Major Depressive Disorder
Clinicians Global Impression Scale (Severity and Improvement)
Time frame: Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Revised Peer Experiences Questionnaire (subscales for Relational and Reputational PV)
Time frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
6 secondary outcomes
Social Anxiety Scale for Adolescents
Time frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Centers for Epidemiological Studies Depression Scale
Time frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Perceived Support Scale- Friends and Family
Time frame: Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Cyber Peer Experiences Questionnaire
Time frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Revised Peer Experiences Questionnaire
Time frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
Health Behaviors
Time frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up
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 17 Dec 2015.
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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.
Annette M La Greca, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UTalk in people with Depression and Social Anxiety, run by University of Miami at 1 site 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 4 inclusion and 7 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 17 Dec 2015. 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 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. 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?
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?
Anxiety Disorder Interview Schedule- Children (ADIS-C) (time frame: Baseline, Change from baseline in Clinician Severity Rating at 12 weeks and at 6 month follow up for Social Anxiety Disorder and Major Depressive Disorder). 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?
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 17 Dec 2015.