Anxiety DisordersPhase 3NCT00052078

Child and Adolescent Anxiety Disorders (CAMS)

A Phase 3 study testing Sertraline (SRT) and Cognitive Behavioral Therapy (CBT) in people with Anxiety Disorders and Social Phobia, run by Johns Hopkins University at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders. Read more about this study

Who is it for?: Ages 7 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety Disorders, Social Phobia, Generalized Anxiety Disorder
What is being tested?: Sertraline (SRT) and Cognitive Behavioral Therapy (CBT)
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 488 participants
Where: 6 sitesUnited States
Study dates: Jan 2003to Mar 2008
Phase: Phase 3
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 7 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder

Who cannot join

Major neurological disorder or medical illness that would interfere with participation in the study

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Johns Hopkins University
Baltimore, Maryland, 21287
Duke University
Durham, North Carolina
UCLA
Los Angeles, California
NYSPI/Columbia University
New York, New York
Temple University
Philadelphia, Pennsylvania
University of Pittsburgh/WPIC
Pittsburgh, Pennsylvania

Other trials in United States

About this study

Official title: Child/Adolescent Anxiety Multimodal Treatment Study

Read the detailed description

Anxiety disorders are among the most common conditions affecting children and adolescents. These disorders impair school, social, and family functioning. When left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. Previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo.

During Phase I of this two-phase study, 488 participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.

Conditions: Anxiety Disorders, Social Phobia, Generalized Anxiety Disorder
Being tested: Sertraline (SRT), Cognitive Behavioral Therapy (CBT), Placebo
Keywords: Phobic Disorders, Anxiety, Separation
Medical subject headings: Anxiety Disorders, Phobia, Social, Generalized Anxiety Disorder, Phobic Disorders, Anxiety, Separation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sertraline (SRT)Drug
Also called Zoloft
Participants were treated with sertraline.
Cognitive Behavioral Therapy (CBT)Behavioural
Participants received CBT.
PlaceboDrug
Participants were treated with a placebo pill.

Study groups in NCT00052078
Study group	Role	What they receive
Sertraline	Active comparator	Participants received sertraline for 12 weeks. Receives: Drug: Sertraline (SRT)
CBT	Active comparator	Participants received cognitive behavioral therapy for 12 weeks Receives: Behavioral: Cognitive Behavioral Therapy (CBT)
SRT + CBT	Active comparator	Participants received both sertraline and CBT for 12 weeks. Receives: Drug: Sertraline (SRT); Behavioral: Cognitive Behavioral Therapy (CBT)
Placebo	Placebo comparator	Participants received a placebo pill for 12 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Global Impression - Improvement Scale
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.
Measured: Measured at Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2003Mar 2008

First posted23 Jan 2003 (estimated)
Study startJan 2003
Primary completionOct 2007
Study completionMar 2008

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 (20)Papers the sponsor has linked to this study.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 488 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00052078
Sponsor's protocol ID: U01MH064089
Other IDs: U01MH064089, DSIR 84-CTP
Status last verified: Aug 2017
First submitted: 22 Jan 2003
Last updated: 19 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes

Publications

Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.
PubMed 18974308
Piacentini J, Bennett S, Compton SN, Kendall PC, Birmaher B, Albano AM, March J, Sherrill J, Sakolsky D, Ginsburg G, Rynn M, Bergman RL, Gosch E, Waslick B, Iyengar S, McCracken J, Walkup J. 24- and 36-week outcomes for the Child/Adolescent Anxiety Multimodal Study (CAMS). J Am Acad Child Adolesc Psychiatry. 2014 Mar;53(3):297-310. doi: 10.1016/j.jaac.2013.11.010. Epub 2013 Nov 28.
PubMed 24565357
Ginsburg GS, Kendall PC, Sakolsky D, Compton SN, Piacentini J, Albano AM, Walkup JT, Sherrill J, Coffey KA, Rynn MA, Keeton CP, McCracken JT, Bergman L, Iyengar S, Birmaher B, March J. Remission after acute treatment in children and adolescents with anxiety disorders: findings from the CAMS. J Consult Clin Psychol. 2011 Dec;79(6):806-13. doi: 10.1037/a0025933.
PubMed 22122292
Compton SN, Walkup JT, Albano AM, Piacentini JC, Birmaher B, Sherrill JT, Ginsburg GS, Rynn MA, McCracken JT, Waslick BD, Iyengar S, Kendall PC, March JS. Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods. Child Adolesc Psychiatry Ment Health. 2010 Jan 5;4:1. doi: 10.1186/1753-2000-4-1.
PubMed 20051130
Compton SN, Peris TS, Almirall D, Birmaher B, Sherrill J, Kendall PC, March JS, Gosch EA, Ginsburg GS, Rynn MA, Piacentini JC, McCracken JT, Keeton CP, Suveg CM, Aschenbrand SG, Sakolsky D, Iyengar S, Walkup JT, Albano AM. Predictors and moderators of treatment response in childhood anxiety disorders: results from the CAMS trial. J Consult Clin Psychol. 2014 Apr;82(2):212-24. doi: 10.1037/a0035458. Epub 2014 Jan 13.
PubMed 24417601
Kendall PC, Compton SN, Walkup JT, Birmaher B, Albano AM, Sherrill J, Ginsburg G, Rynn M, McCracken J, Gosch E, Keeton C, Bergman L, Sakolsky D, Suveg C, Iyengar S, March J, Piacentini J. Clinical characteristics of anxiety disordered youth. J Anxiety Disord. 2010 Apr;24(3):360-5. doi: 10.1016/j.janxdis.2010.01.009. Epub 2010 Feb 6.
PubMed 20206470
Meyer M, Olino TM, Albano AM, Piacentini JC, Compton SN, Gosch EA, Kendall PC. Changes in idiographic coping in youth treated for an anxiety disorder. J Child Psychol Psychiatry. 2026 Aug;67(8):1321-1334. doi: 10.1111/jcpp.70139. Epub 2026 Mar 3.
PubMed 41773906
Rabner J, Olino TM, Albano AM, Keeton CP, Sakolsky D, Birmaher B, Piacentini J, Peris TS, Compton SN, Gosch E, Ginsburg GS, Pinney EL, Kendall PC. Substance use outcomes from the Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS). J Child Psychol Psychiatry. 2024 Jul;65(7):910-920. doi: 10.1111/jcpp.13926. Epub 2024 Jan 12.
PubMed 38217328
Strawn JR, Mills JA, Rothenberg R, Piacentini J, Peris TS, McCracken JT, Walkup JT. Initiation of Pharmacotherapy Following CBT in Anxious Youth: Results From the Child/Adolescent Anxiety Multimodal Study (CAMS). J Clin Psychiatry. 2022 Dec 5;84(1):22m14524. doi: 10.4088/JCP.22m14524.
PubMed 36479955
Crane ME, Norris LA, Frank HE, Klugman J, Ginsburg GS, Keeton C, Albano AM, Piacentini J, Peris TS, Compton SN, Sakolsky D, Birmaher B, Kendall PC. Impact of treatment improvement on long-term anxiety: Results from CAMS and CAMELS. J Consult Clin Psychol. 2021 Feb;89(2):126-133. doi: 10.1037/ccp0000523.
PubMed 33705168
Cervin M, Storch EA, Piacentini J, Birmaher B, Compton SN, Albano AM, Gosch E, Walkup JT, Kendall PC. Symptom-specific effects of cognitive-behavioral therapy, sertraline, and their combination in a large randomized controlled trial of pediatric anxiety disorders. J Child Psychol Psychiatry. 2020 Apr;61(4):492-502. doi: 10.1111/jcpp.13124. Epub 2019 Aug 30.
PubMed 31471911
Albano AM, Comer JS, Compton SN, Piacentini J, Kendall PC, Birmaher B, Walkup JT, Ginsburg GS, Rynn MA, McCracken J, Keeton C, Sakolsky DJ, Sherrill JT. Secondary Outcomes From the Child/Adolescent Anxiety Multimodal Study: Implications for Clinical Practice. Evid Based Pract Child Adolesc Ment Health. 2018;3(1):30-41. doi: 10.1080/23794925.2017.1399485. Epub 2017 Dec 5.
PubMed 30906874
Ginsburg GS, Becker-Haimes EM, Keeton C, Kendall PC, Iyengar S, Sakolsky D, Albano AM, Peris T, Compton SN, Piacentini J. Results From the Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS): Primary Anxiety Outcomes. J Am Acad Child Adolesc Psychiatry. 2018 Jul;57(7):471-480. doi: 10.1016/j.jaac.2018.03.017. Epub 2018 May 9.
PubMed 29960692
Kiff CJ, Ernestus S, Gonzalez A, Kendall PC, Albano AM, Compton SN, Birmaher B, Ginsburg GS, Rynn M, Walkup JT, McCracken J, Piacentini J. The Interplay of Familial and Individual Risk in Predicting Clinical Improvements in Pediatric Anxiety Disorders. J Clin Child Adolesc Psychol. 2018;47(sup1):S542-S554. doi: 10.1080/15374416.2018.1460848. Epub 2018 Jun 7.
PubMed 29877727
Taylor JH, Lebowitz ER, Jakubovski E, Coughlin CG, Silverman WK, Bloch MH. Monotherapy Insufficient in Severe Anxiety? Predictors and Moderators in the Child/Adolescent Anxiety Multimodal Study. J Clin Child Adolesc Psychol. 2018 Mar-Apr;47(2):266-281. doi: 10.1080/15374416.2017.1371028. Epub 2017 Sep 28.
PubMed 28956620

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Child/Adolescent Anxiety Multimodal Treatment Study
ClinicalTrials.gov ID: NCT00052078
Acronym / sponsor ID: U01MH064089
Conditions: Anxiety Disorders, Social Phobia, Generalized Anxiety Disorder
Keywords: Phobic Disorders, Anxiety, Separation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 488 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Jan 2003
Primary completion: Oct 2007 (actual)
Study completion: Mar 2008 (actual)
First posted: 23 Jan 2003 (estimated)
Results: Posted 25 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Sertraline	Active comparator	Drug: Sertraline (SRT)Participants received sertraline for 12 weeks.
CBT	Active comparator	Behavioral: Cognitive Behavioral Therapy (CBT)Participants received cognitive behavioral therapy for 12 weeks
SRT + CBT	Active comparator	Drug: Sertraline (SRT), Behavioral: Cognitive Behavioral Therapy (CBT)Participants received both sertraline and CBT for 12 weeks.
Placebo	Placebo comparator	Drug: PlaceboParticipants received a placebo pill for 12 weeks.

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder

Key exclusion criteria (1 listed)

Major neurological disorder or medical illness that would interfere with participation in the study

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
Sertraline (SRT)Also: ZoloftParticipants were treated with sertraline.	Drug	SRT + CBT, Sertraline
Cognitive Behavioral Therapy (CBT)Participants received CBT.	Behavioural	CBT, SRT + CBT
PlaceboParticipants were treated with a placebo pill.	Drug	Placebo

Primary outcome

Clinical Global Impression - Improvement Scale
Time frame: Measured at Week 12
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.

Results and safety

Results posted to the registry on 25 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 Setraline	133	110
2 CBT	139	133
3 Combination Setraline and CBT	140	127
4 Placebo	76	61

Primary outcome: Clinical Global Impression - Improvement Scale

Time frame: Measured at Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	1 Setraline n = 133	2 CBT n = 139	3 Combination Setraline and CBT n = 140	4 Placebo n = 76
Value	54.9 (46.4 to 63.1)	59.7 (51.4 to 67.5)	80.7 (73.3 to 86.4)	23.7 (15.5 to 34.5)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Setraline	2 of 133 (1.5%)	0 of 133 (0%)	Not reported
2 CBT	0 of 139 (0%)	0 of 139 (0%)	Not reported
3 Combination Setraline + CBT	1 of 140 (0.7%)	0 of 140 (0%)	Not reported
4 Placebo	0 of 76 (0%)	0 of 76 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 18974308Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.
Results publication: PubMed 24565357Piacentini J, Bennett S, Compton SN, Kendall PC, Birmaher B, Albano AM, March J, Sherrill J, Sakolsky D, Ginsburg G, Rynn M, Bergman RL, Gosch E, Waslick B, Iyengar S, McCracken J, Walkup J. 24- and 36-week outcomes for the Child/Adolescent Anxiety Multimodal Study (CAMS). J Am Acad Child Adolesc Psychiatry. 2014 Mar;53(3):297-310. doi: 10.1016/j.jaac.2013.11.010. Epub 2013 Nov 28.
Results publication: PubMed 22122292Ginsburg GS, Kendall PC, Sakolsky D, Compton SN, Piacentini J, Albano AM, Walkup JT, Sherrill J, Coffey KA, Rynn MA, Keeton CP, McCracken JT, Bergman L, Iyengar S, Birmaher B, March J. Remission after acute treatment in children and adolescents with anxiety disorders: findings from the CAMS. J Consult Clin Psychol. 2011 Dec;79(6):806-13. doi: 10.1037/a0025933.
Results publication: PubMed 20051130Compton SN, Walkup JT, Albano AM, Piacentini JC, Birmaher B, Sherrill JT, Ginsburg GS, Rynn MA, McCracken JT, Waslick BD, Iyengar S, Kendall PC, March JS. Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods. Child Adolesc Psychiatry Ment Health. 2010 Jan 5;4:1. doi: 10.1186/1753-2000-4-1.
Results publication: PubMed 24417601Compton SN, Peris TS, Almirall D, Birmaher B, Sherrill J, Kendall PC, March JS, Gosch EA, Ginsburg GS, Rynn MA, Piacentini JC, McCracken JT, Keeton CP, Suveg CM, Aschenbrand SG, Sakolsky D, Iyengar S, Walkup JT, Albano AM. Predictors and moderators of treatment response in childhood anxiety disorders: results from the CAMS trial. J Consult Clin Psychol. 2014 Apr;82(2):212-24. doi: 10.1037/a0035458. Epub 2014 Jan 13.
Results publication: PubMed 20206470Kendall PC, Compton SN, Walkup JT, Birmaher B, Albano AM, Sherrill J, Ginsburg G, Rynn M, McCracken J, Gosch E, Keeton C, Bergman L, Sakolsky D, Suveg C, Iyengar S, March J, Piacentini J. Clinical characteristics of anxiety disordered youth. J Anxiety Disord. 2010 Apr;24(3):360-5. doi: 10.1016/j.janxdis.2010.01.009. Epub 2010 Feb 6.
Derived from this study: PubMed 41773906Meyer M, Olino TM, Albano AM, Piacentini JC, Compton SN, Gosch EA, Kendall PC. Changes in idiographic coping in youth treated for an anxiety disorder. J Child Psychol Psychiatry. 2026 Aug;67(8):1321-1334. doi: 10.1111/jcpp.70139. Epub 2026 Mar 3.
Derived from this study: PubMed 38217328Rabner J, Olino TM, Albano AM, Keeton CP, Sakolsky D, Birmaher B, Piacentini J, Peris TS, Compton SN, Gosch E, Ginsburg GS, Pinney EL, Kendall PC. Substance use outcomes from the Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS). J Child Psychol Psychiatry. 2024 Jul;65(7):910-920. doi: 10.1111/jcpp.13926. Epub 2024 Jan 12.
Derived from this study: PubMed 36479955Strawn JR, Mills JA, Rothenberg R, Piacentini J, Peris TS, McCracken JT, Walkup JT. Initiation of Pharmacotherapy Following CBT in Anxious Youth: Results From the Child/Adolescent Anxiety Multimodal Study (CAMS). J Clin Psychiatry. 2022 Dec 5;84(1):22m14524. doi: 10.4088/JCP.22m14524.
Derived from this study: PubMed 33705168Crane ME, Norris LA, Frank HE, Klugman J, Ginsburg GS, Keeton C, Albano AM, Piacentini J, Peris TS, Compton SN, Sakolsky D, Birmaher B, Kendall PC. Impact of treatment improvement on long-term anxiety: Results from CAMS and CAMELS. J Consult Clin Psychol. 2021 Feb;89(2):126-133. doi: 10.1037/ccp0000523.
Derived from this study: PubMed 31471911Cervin M, Storch EA, Piacentini J, Birmaher B, Compton SN, Albano AM, Gosch E, Walkup JT, Kendall PC. Symptom-specific effects of cognitive-behavioral therapy, sertraline, and their combination in a large randomized controlled trial of pediatric anxiety disorders. J Child Psychol Psychiatry. 2020 Apr;61(4):492-502. doi: 10.1111/jcpp.13124. Epub 2019 Aug 30.
Derived from this study: PubMed 30906874Albano AM, Comer JS, Compton SN, Piacentini J, Kendall PC, Birmaher B, Walkup JT, Ginsburg GS, Rynn MA, McCracken J, Keeton C, Sakolsky DJ, Sherrill JT. Secondary Outcomes From the Child/Adolescent Anxiety Multimodal Study: Implications for Clinical Practice. Evid Based Pract Child Adolesc Ment Health. 2018;3(1):30-41. doi: 10.1080/23794925.2017.1399485. Epub 2017 Dec 5.
Individual participant dataSharing planned: Yes

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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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sertraline (SRT) and Cognitive Behavioral Therapy (CBT) in people with Anxiety Disorders and Social Phobia, run by Johns Hopkins University 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 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 19 Sep 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 25 Apr 2017). 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?

Clinical Global Impression - Improvement Scale (time frame: Measured at Week 12). 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 NCT00052078, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.