Anxiety DisordersBASICNCT01463241
Behavioral and Affective Skills in Coping (BASIC) Open Trial
A study testing Behavioral and Affective Skills in Coping (BASIC) in people with Anxiety Disorders and Depressive Disorders, run by Judge Baker Children's Center at 1 site in United States.
Trial summary
The overall objective of the project is to develop and assess the feasibility of a brief, practice-friendly approach to psychotherapy for children, entitled Behavioral and Affective Skills in Coping (BASIC) and designed for use as a first step toward evidence-based practice by practitioners in clinical service… Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Anxiety Disorders, Depressive Disorders, Disruptive Behavior Disorders
- What is being tested?
- Behavioral and Affective Skills in Coping (BASIC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Oct 2013
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8-15 year-old youth
- The youth will meet diagnostic criteria for one or more target disorders in the broad areas of anxiety (including Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Obsessive Compulsive Disorder, Specific Phobia, Panic Disorder, Anxiety Disorder Not Otherwise Specified, Adjustment Disorder with Anxiety), depression (including Major Depressive Disorder, Dysthymic Disorder, Minor Depression, Depressive Disorder Not Otherwise Specified, Adjustment Disorder with Depressed Mood), and conduct (Oppositional Defiant Disorder, Conduct Disorder, Disruptive Behavior Disorder Not Otherwise Specified, Adjustment Disorder with Disturbance of Conduct).
Who cannot join
- Youth with primary ADHD
- Youth with developmental disorders
- Youth with symptoms of a thought disorder including delusions and hallucinations
Trial locations and contacts
1 site in 1 country.
United States1 site
Judge Baker Children's Center
Boston, Massachusetts, 02120
About this study
Official title: Behavioral and Affective Skills in Coping: Practice-Adapted Child Psychotherapy
The overall objective of the project is to develop and assess the feasibility of a brief, practice-friendly approach to psychotherapy for children, entitled Behavioral and Affective Skills in Coping (BASIC) and designed for use as a first step toward evidence-based practice by practitioners in clinical service settings.
Read the detailed description
The investigators seek to develop a treatment protocol that integrates five core intervention principles that are common to evidence-based treatments for youth depression, anxiety, and disruptive behavior problems. The protocol will be designed for implementation in everyday community practice settings by practitioners. Because many empirically supported treatments for youth disorders address only one area of impairment, they may not be an ideal fit to community clinics, where (a) most practitioners treat an array of disorders rather than specializing in just one, (b) most referred youths present with multiple disorders, and (c) priority problems and treatment needs may shift for many youths during an episode of care. Moreover, because many evidence-based treatments have been developed in research settings, they may not be designed in ways that are ideal for front-line therapists in community settings. The investigators hope to reduce the difficulty of transporting treatments into community practice by incorporating the perspectives of community practitioners in the development and design of the protocol. By incorporating the feedback of expert treatment developers, the investigators hope to ensure that BASIC is not only appealing to users but also consistent with what has been learned through treatment research over the years. Finally, the trial will provide preliminary evidence on whether this brief "first course" in evidence-based treatment is beneficial for youths with depression, anxiety, and disruptive behavior problems-three clusters that account for a large percentage of youth referrals.
- Being tested
- Behavioral and Affective Skills in Coping (BASIC)
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral and Affective Skills in Coping (BASIC)Behavioural
The investigator's seek to develop a treatment protocol that integrates five core intervention principles that are common to evidence-based treatments for youth depression, anxiety, and disruptive behavior problems. The protocol will be designed for implementation in everyday community practice settings by practitioners. The BASIC protocol will include (a) a therapist manual guiding the use of five BASIC skills [Belief Repair, Action, Solving Problems, Incentives, and Calming]; (b) child and parent materials to facilitate learning skills, practicing them in-session, and using them outside sessions; and (c) a decision tree to guide judgments about which skills to use and when to switch skills or treatment focus.
| Study group | Role | What they receive |
|---|---|---|
| BASIC treatment | Other | As an open trial, all participants in this study will receive the BASIC treatment. Receives: Behavioral: Behavioral and Affective Skills in Coping (BASIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in diagnostic status at post-treatment: Schedule for Affective Disorders and Schizophrenia for School-Age Children- Present and Lifetime Version (K-SADS-PL)
The K-SADS-PL (Puig-Antich \& Chambers, 1983; Kaufman et al., 1997) is a semi-structured diagnostic interview designed to be used for youth ages 6 through 18. The K-SADS-PL will be used to diagnose DSM-IV disorders, and has been found to have acceptable test-retest reliability (κs = .60 - 1.00), inter-rater reliability (κs = .60 - 1.00) and internal consistency (αs = .68 - .84), and to discriminate between disordered and non-disordered children (Ambrosini, 2000; Kaufman et al., 1997; Lewinsohn, et al., 1994).
Measured: Immediately before and after the treatment course, which is expected to last an average of 7 months
Change from baseline in child/adolescent problem areas at post-treatment: Child Behavior Checklist -- Problem Portion (CBCL)
The CBCL obtains caregiver reports on 118 child/adolescent problems, each rated on a 0-1-2 scale. The CBCL is a widely-used and psychometrically sound measure with well-developed norms (Achenbach, 2001), and it yields T-scores for eight narrow-band syndrome scales (Anxious-Depressed, Withdrawn-Depressed, Somatic Complaints, Attention Problems, Thought Problems, Social Problems, Aggressive Behavior, and Rule-Breaking Behavior), two broad-band second-order syndrome scales (Internalizing and Externalizing), and a Total Problems scale.
Measured: Immediately before and after the treatment course, which is expected to last an average of 7 months
Change from baseline in child/adolescent problem areas at post-treatment: Youth Self-Report Form -- Problem Portion (YSR)
The YSR is a 118-items assessing symptoms across a broad range of clinical significance, overlapping heavily with the content of the parent-report CBCL. The YSR is normed for children aged 11 and older, but item wording is quite simple, and data from clinic-referred children (Yeh \& Weisz, 2001) have shown that the measure performs as well psychometrically for children aged 7-10 as for youths aged 11-17; this suggests that the YSR may be appropriately employed with youngsters across the full age range of the current sample.
Measured: Immediately before and after the treatment course, which is expected to last an average of 7 months
Change from baseline in child/adolescent problem areas during treatment and at post-treatment: Brief Problem Checklist (BPC; Chorpita, Reise, Weisz, et al. 2010)
The BPC is a 12-item questionnaire that has both parent and youth versions designed to provide a brief, easily administered, clinically relevant, and psychometrically sound measure of symptoms and problems. The items for this measure were developed using item response theory and factor analysis applied to the CBCL and YSR and ask about symptoms of internalizing and externalizing problems in the last week. Internal consistency for the BPC ranged from .70 to .83. Test-retest reliability was also good, with Cronbach's alpha falling in the range of .72 to.79.
Measured: Participants will be followed for the duration of the treatment course, an expected average of 7 months
Change from baseline in target problem during treatment and at post-treatment: Weekly Target Problem Report (TPR; STEPs Team, 2008)
The TPR tracks trajectories of change in the target problems identified by caregivers and children at the start of treatment. In the initial assessment, the caregiver and child are separately asked to identify the "problems for which you/your child most need/s help." The 3 top-ranked problems are then rated for severity in weekly phone calls. TPR ratings have been shown to be sensitive to change over time and in ways that differ for different treatments; moreover, the TPR is a consumer-sensitive index of treatment response, reflecting the concerns for which caregiver and child sought help.
Measured: Participants will be followed for the duration of the treatment course, an expected average of 7 months
Change from baseline in clinical global impression during treatment course: Clinical Global Impression-Improvement (CGI-I) Scale (Guy, 1970).
The CGI-I is a 7-point scale to be completed by practitioners each week, indicating their rating of client improvement relative to baseline severity. The CGI-I has been used as a measure of treatment response in studies testing CBT for anxiety disorders, CBT for depression, and Behavioral Caregiver Training for disruptive behavior in children with ADHD. The CGI-I has demonstrated acceptable convergent validity between clinicians and blind assessors rating children's response to treatment.
Measured: Participants will be followed for the duration of the treatment course, an expected average of 7 months
Secondary outcomes (6)
Services for Children & Adolescents - Parent Interview (SCAPI; Jensen et al., 2004)
The SCAPI is an interview administered to parents to assess children's services use across primary care, specialty mental health, and other settings. It is administered in two parts. In Part I, parents are asked about psychotropic medications the child receives. In Part II, parents are asked to document any recent visits the child has made to their physician. Test-retest κ values ranged from .49 to 1.00, with an overall κ value for all services of .97.
Measured: Participants will be followed for the duration of the treatment course, an expected average of 7 months
Service Assessment for Children and Adolescents-Treatment and Auxiliary Service Use Scales (SACA; Horwitz et al., 2001)
The SACA is a standardized interview for parents that collects information on use of mental health services across a broad spectrum (including outpatient, inpatient, and school-based). SACA reliability and validity data are well-documented.
Measured: Participants will be followed for the duration of the treatment course, an expected average of 7 months
Therapeutic Alliance Scale for Children (TASC; Shirk & Saiz, 1992)
The TASC assesses the quality of youths' working alliance with their therapists. Originally designed to examine youth in inpatient settings, the 9-item revised scale comes in both a youth-report form and a parent-report form (parents reporting on their youth's relationship with the therapist). The TASC has demonstrated adequate internal consistency ranging from .72 to .74.
Measured: Following the participant's treatment course, which is expected to last an average of 7 months
Therapy Process Observational Coding System-Alliance Scale (TPOCS-A; McLeod & Weisz, 2005)
The TPOCS-A assesses child-clinician and caregiver-clinician alliance through observational ratings of recorded therapy sessions. The TPOCS-A was derived from questionnaire measures of alliance, adapting items that could be expressed in terms of observable behavior, both reflecting alliance or its absence. Psychometric analyses based on child and caregiver sessions in community outpatient clinics showed that both child and caregiver forms have good inter-rater reliability and internal consistency. Psychometric analyses also found that both child and caregiver forms predicted treatment outcome.
Measured: Following the participant's treatment course, which is expected to last an average of 7 months
Parent Child Satisfaction Scales (PCSS; Hawley, Weersing, & Weisz, 1998)
The Parent Child Satisfaction Scales consist of an 8-item parent measure and an 8-item child measure that assess the child's satisfaction with the treatment he or she received as well as the parents' satisfaction with their child's treatment.
Measured: Following the participant's treatment course, which is expected to last an average of 7 months
Therapist Satisfaction Inventory (TSI; Addis & Krasnow's, 2000)
The TSI is a 16-item therapist-report measure derived from Addis \& Krasnow's (2000) report on therapist attitudes toward manualized treatments. The items encompass whether therapists liked the treatment approach they used, whether they perceived that the approach was effective, whether they believe it allowed them to individualize treatment to fit client needs, and whether the approach seems appropriate for the kinds of children they most often see.
Measured: Following the clinician's participation in the study, which is anticipated to last 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Judge Baker Children's Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R. Weisz, PhD, ABPP, Harvard University
- Investigators
- John R Weisz, Ph.D., ABPP, Principal investigator, Department of Psychology, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463241
- Sponsor's protocol ID
- R34MH085963-03
- Acronym
- BASIC
- Status last verified
- Apr 2015
- First submitted
- 26 Oct 2011
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Affective Skills in Coping: Practice-Adapted Child Psychotherapy
- ClinicalTrials.gov ID
- NCT01463241
- Acronym / sponsor ID
- BASIC / R34MH085963-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Judge Baker Children's CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Nov 2011 (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 overall objective of the project is to develop and assess the feasibility of a brief, practice-friendly approach to psychotherapy for children, entitled Behavioral and Affective Skills in Coping (BASIC) and designed for use as a first step toward evidence-based practice by practitioners in clinical service settings.
Detailed description
The investigators seek to develop a treatment protocol that integrates five core intervention principles that are common to evidence-based treatments for youth depression, anxiety, and disruptive behavior problems. The protocol will be designed for implementation in everyday community practice settings by practitioners. Because many empirically supported treatments for youth disorders address only one area of impairment, they may not be an ideal fit to community clinics, where (a) most practitioners treat an array of disorders rather than specializing in just one, (b) most referred youths present with multiple disorders, and (c) priority problems and treatment needs may shift for many youths during an episode of care. Moreover, because many evidence-based treatments have been developed in research settings, they may not be designed in ways that are ideal for front-line therapists in community settings. The investigators hope to reduce the difficulty of transporting treatments into community practice by incorporating the perspectives of community practitioners in the development and design of the protocol. By incorporating the feedback of expert treatment developers, the investigators hope to ensure that BASIC is not only appealing to users but also consistent with what has been learned through treatment research over the years. Finally, the trial will provide preliminary evidence on whether this brief "first course" in evidence-based treatment is beneficial for youths with depression, anxiety, and disruptive behavior problems-three clusters that account for a large percentage of youth referrals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BASIC treatment | Other | Behavioral: Behavioral and Affective Skills in Coping (BASIC)As an open trial, all participants in this study will receive the BASIC treatment. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 8-15 year-old youth
- The youth will meet diagnostic criteria for one or more target disorders in the broad areas of anxiety (including Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Obsessive Compulsive Disorder, Specific Phobia, Panic Disorder, Anxiety Disorder Not Otherwise Specified, Adjustment Disorder with Anxiety), depression (including Major Depressive Disorder, Dysthymic Disorder, Minor Depression, Depressive Disorder Not Otherwise Specified, Adjustment Disorder with Depressed Mood), and conduct (Oppositional Defiant Disorder, Conduct Disorder, Disruptive Behavior Disorder Not Otherwise Specified, Adjustment Disorder with Disturbance of Conduct).
Key exclusion criteria (3 listed)
- Youth with primary ADHD
- Youth with developmental disorders
- Youth with symptoms of a thought disorder including delusions and hallucinations
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 |
|---|---|---|
| Behavioral and Affective Skills in Coping (BASIC)The investigator's seek to develop a treatment protocol that integrates five core intervention principles that are common to evidence-based treatments for youth depression, anxiety, and disruptive behavior problems. The protocol will be designed for implementation in everyday community practice settings by practitioners. The BASIC protocol will include (a) a therapist manual guiding the use of five BASIC skills [Belief Repair, Action, Solving Problems, Incentives, and Calming]; (b) child and parent materials to facilitate learning skills, practicing them in-session, and using them outside sessions; and (c) a decision tree to guide judgments about which skills to use and when to switch skills or treatment focus. | Behavioural | BASIC treatment |
Primary outcome
Change from baseline in diagnostic status at post-treatment: Schedule for Affective Disorders and Schizophrenia for School-Age Children- Present and Lifetime Version (K-SADS-PL)
Time frame: Immediately before and after the treatment course, which is expected to last an average of 7 months
The K-SADS-PL (Puig-Antich \& Chambers, 1983; Kaufman et al., 1997) is a semi-structured diagnostic interview designed to be used for youth ages 6 through 18. The K-SADS-PL will be used to diagnose DSM-IV disorders, and has been found to have acceptable test-retest reliability (κs = .60 - 1.00), inter-rater reliability (κs = .60 - 1.00) and internal consistency (αs = .68 - .84), and to discriminate between disordered and non-disordered children (Ambrosini, 2000; Kaufman et al., 1997; Lewinsohn, et al., 1994).
Change from baseline in child/adolescent problem areas at post-treatment: Child Behavior Checklist -- Problem Portion (CBCL)
Time frame: Immediately before and after the treatment course, which is expected to last an average of 7 months
The CBCL obtains caregiver reports on 118 child/adolescent problems, each rated on a 0-1-2 scale. The CBCL is a widely-used and psychometrically sound measure with well-developed norms (Achenbach, 2001), and it yields T-scores for eight narrow-band syndrome scales (Anxious-Depressed, Withdrawn-Depressed, Somatic Complaints, Attention Problems, Thought Problems, Social Problems, Aggressive Behavior, and Rule-Breaking Behavior), two broad-band second-order syndrome scales (Internalizing and Externalizing), and a Total Problems scale.
Change from baseline in child/adolescent problem areas at post-treatment: Youth Self-Report Form -- Problem Portion (YSR)
Time frame: Immediately before and after the treatment course, which is expected to last an average of 7 months
The YSR is a 118-items assessing symptoms across a broad range of clinical significance, overlapping heavily with the content of the parent-report CBCL. The YSR is normed for children aged 11 and older, but item wording is quite simple, and data from clinic-referred children (Yeh \& Weisz, 2001) have shown that the measure performs as well psychometrically for children aged 7-10 as for youths aged 11-17; this suggests that the YSR may be appropriately employed with youngsters across the full age range of the current sample.
Change from baseline in child/adolescent problem areas during treatment and at post-treatment: Brief Problem Checklist (BPC; Chorpita, Reise, Weisz, et al. 2010)
Time frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
The BPC is a 12-item questionnaire that has both parent and youth versions designed to provide a brief, easily administered, clinically relevant, and psychometrically sound measure of symptoms and problems. The items for this measure were developed using item response theory and factor analysis applied to the CBCL and YSR and ask about symptoms of internalizing and externalizing problems in the last week. Internal consistency for the BPC ranged from .70 to .83. Test-retest reliability was also good, with Cronbach's alpha falling in the range of .72 to.79.
Change from baseline in target problem during treatment and at post-treatment: Weekly Target Problem Report (TPR; STEPs Team, 2008)
Time frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
The TPR tracks trajectories of change in the target problems identified by caregivers and children at the start of treatment. In the initial assessment, the caregiver and child are separately asked to identify the "problems for which you/your child most need/s help." The 3 top-ranked problems are then rated for severity in weekly phone calls. TPR ratings have been shown to be sensitive to change over time and in ways that differ for different treatments; moreover, the TPR is a consumer-sensitive index of treatment response, reflecting the concerns for which caregiver and child sought help.
Change from baseline in clinical global impression during treatment course: Clinical Global Impression-Improvement (CGI-I) Scale (Guy, 1970).
Time frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
The CGI-I is a 7-point scale to be completed by practitioners each week, indicating their rating of client improvement relative to baseline severity. The CGI-I has been used as a measure of treatment response in studies testing CBT for anxiety disorders, CBT for depression, and Behavioral Caregiver Training for disruptive behavior in children with ADHD. The CGI-I has demonstrated acceptable convergent validity between clinicians and blind assessors rating children's response to treatment.
6 secondary outcomes
Services for Children & Adolescents - Parent Interview (SCAPI; Jensen et al., 2004)
Time frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
Service Assessment for Children and Adolescents-Treatment and Auxiliary Service Use Scales (SACA; Horwitz et al., 2001)
Time frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
Therapeutic Alliance Scale for Children (TASC; Shirk & Saiz, 1992)
Time frame: Following the participant's treatment course, which is expected to last an average of 7 months
Therapy Process Observational Coding System-Alliance Scale (TPOCS-A; McLeod & Weisz, 2005)
Time frame: Following the participant's treatment course, which is expected to last an average of 7 months
Parent Child Satisfaction Scales (PCSS; Hawley, Weersing, & Weisz, 1998)
Time frame: Following the participant's treatment course, which is expected to last an average of 7 months
Therapist Satisfaction Inventory (TSI; Addis & Krasnow's, 2000)
Time frame: Following the clinician's participation in the study, which is anticipated to last 18 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 16 Apr 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.
John R Weisz, Ph.D., ABPP principal investigator
Department of Psychology, Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral and Affective Skills in Coping (BASIC) in people with Anxiety Disorders and Depressive Disorders, run by Judge Baker Children's Center 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 2 inclusion and 3 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 16 Apr 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.
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 from baseline in diagnostic status at post-treatment: Schedule for Affective Disorders and Schizophrenia for School-Age Children- Present and Lifetime Version (K-SADS-PL) (time frame: Immediately before and after the treatment course, which is expected to last an average of 7 months). The study lists 6 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 16 Apr 2015.