NCT00052078

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

April 25, 2017

Completed
Last Updated

September 19, 2017

Status Verified

August 1, 2017

Enrollment Period

4.8 years

First QC Date

January 22, 2003

Results QC Date

July 29, 2016

Last Update Submit

August 21, 2017

Conditions

Anxiety DisordersSocial PhobiaGeneralized Anxiety Disorder

Keywords

Phobic DisordersAnxiety, Separation

Outcome Measures

Primary Outcomes (1)

  • 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 at Week 12

Study Arms (4)

Sertraline

ACTIVE COMPARATOR

Participants received sertraline for 12 weeks.

Drug: Sertraline (SRT)

CBT

ACTIVE COMPARATOR

Participants received cognitive behavioral therapy for 12 weeks

Behavioral: Cognitive Behavioral Therapy (CBT)

SRT + CBT

ACTIVE COMPARATOR

Participants received both sertraline and CBT for 12 weeks.

Drug: Sertraline (SRT)Behavioral: Cognitive Behavioral Therapy (CBT)

Placebo

PLACEBO COMPARATOR

Participants received a placebo pill for 12 weeks.

Drug: Placebo

Interventions

Sertraline (SRT)DRUG

Participants were treated with sertraline.

Also known as: Zoloft
SRT + CBTSertraline
Cognitive Behavioral Therapy (CBT)BEHAVIORAL

Participants received CBT.

CBTSRT + CBT
PlaceboDRUG

Participants were treated with a placebo pill.

Placebo

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCLA

Los Angeles, California, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

NYSPI/Columbia University

New York, New York, United States

Location

Duke University

Durham, North Carolina, United States

Location

Temple University

Philadelphia, Pennsylvania, United States

Location

University of Pittsburgh/WPIC

Pittsburgh, Pennsylvania, United States

Location

Related Publications (18)

  • 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.

    PMID: 18974308RESULT

  • 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.

    PMID: 24565357RESULT

  • 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.

    PMID: 22122292RESULT

  • 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.

    PMID: 20051130RESULT

  • 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.

    PMID: 24417601RESULT

  • 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.

    PMID: 20206470RESULT

  • 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.

    PMID: 36479955DERIVED

  • 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.

    PMID: 33705168DERIVED

  • 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.

    PMID: 31471911DERIVED

  • 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.

    PMID: 30906874DERIVED

  • 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.

    PMID: 29960692DERIVED

  • 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.

    PMID: 29877727DERIVED

  • 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.

    PMID: 28956620DERIVED

  • Caporino NE, Sakolsky D, Brodman DM, McGuire JF, Piacentini J, Peris TS, Ginsburg GS, Walkup JT, Iyengar S, Kendall PC, Birmaher B. Establishing Clinical Cutoffs for Response and Remission on the Screen for Child Anxiety Related Emotional Disorders (SCARED). J Am Acad Child Adolesc Psychiatry. 2017 Aug;56(8):696-702. doi: 10.1016/j.jaac.2017.05.018. Epub 2017 Jun 6.

    PMID: 28735699DERIVED

  • Rynn MA, Walkup JT, Compton SN, Sakolsky DJ, Sherrill JT, Shen S, Kendall PC, McCracken J, Albano AM, Piacentini J, Riddle MA, Keeton C, Waslick B, Chrisman A, Iyengar S, March JS, Birmaher B. Child/Adolescent anxiety multimodal study: evaluating safety. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):180-90. doi: 10.1016/j.jaac.2014.12.015. Epub 2014 Dec 31.

    PMID: 25721183DERIVED

  • Gonzalez A, Peris TS, Vreeland A, Kiff CJ, Kendall PC, Compton SN, Albano AM, Birmaher B, Ginsburg GS, Keeton CP, March J, McCracken J, Rynn M, Sherrill J, Walkup JT, Piacentini J. Parental anxiety as a predictor of medication and CBT response for anxious youth. Child Psychiatry Hum Dev. 2015 Feb;46(1):84-93. doi: 10.1007/s10578-014-0454-6.

    PMID: 24610431DERIVED

  • Ginsburg GS, Becker EM, Keeton CP, Sakolsky D, Piacentini J, Albano AM, Compton SN, Iyengar S, Sullivan K, Caporino N, Peris T, Birmaher B, Rynn M, March J, Kendall PC. Naturalistic follow-up of youths treated for pediatric anxiety disorders. JAMA Psychiatry. 2014 Mar;71(3):310-8. doi: 10.1001/jamapsychiatry.2013.4186.

    PMID: 24477837DERIVED

  • Crawley SA, Caporino NE, Birmaher B, Ginsburg G, Piacentini J, Albano AM, Sherrill J, Sakolsky D, Compton SN, Rynn M, McCracken J, Gosch E, Keeton C, March J, Walkup JT, Kendall PC. Somatic complaints in anxious youth. Child Psychiatry Hum Dev. 2014 Aug;45(4):398-407. doi: 10.1007/s10578-013-0410-x.

    PMID: 24129543DERIVED

MeSH Terms

Conditions

Anxiety DisordersPhobia, SocialGeneralized Anxiety DisorderPhobic DisordersAnxiety, Separation

Interventions

SertralineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
John Walkup
Organization
Johns Hopkins University
jtw9001@med.cornell.edu
212-746-1891

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2003

First Posted

January 23, 2003

Study Start

January 1, 2003

Primary Completion

October 1, 2007

Study Completion

March 1, 2008

Last Updated

September 19, 2017

Results First Posted

April 25, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

Locations

US(6)