Child and Adolescent Anxiety Disorders (CAMS)

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00052078
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 488
• Locations: 6
• Arms: 4
• Duration (Months): 62
• Patients Per Site: 81.3
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders; Social Phobia; Generalized Anxiety Disorder	Drug: Sertraline (SRT); Behavioral: Cognitive Behavioral Therapy (CBT); Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 488 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Child/Adolescent Anxiety Multimodal Treatment Study
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sertraline Participants received sertraline for 12 weeks.	Drug: Sertraline (SRT); Participants were treated with sertraline.; Other Names: Zoloft
Active Comparator: CBT Participants received cognitive behavioral therapy for 12 weeks	Behavioral: Cognitive Behavioral Therapy (CBT); Participants received CBT.
Active Comparator: SRT + CBT Participants received both sertraline and CBT for 12 weeks.	Drug: Sertraline (SRT); Participants were treated with sertraline.; Other Names: Zoloft ; Behavioral: Cognitive Behavioral Therapy (CBT); Participants received CBT.
Placebo Comparator: Placebo Participants received a placebo pill for 12 weeks.	Drug: Placebo; Participants were treated with a placebo pill.

Outcome Measures

Primary Outcome Measures

1. Clinical Global Impression - Improvement Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States
2	Johns Hopkins University	Baltimore	Maryland	United States	21287
3	NYSPI/Columbia University	New York	New York	United States
4	Duke University	Durham	North Carolina	United States
5	Temple University	Philadelphia	Pennsylvania	United States
6	University of Pittsburgh/WPIC	Pittsburgh	Pennsylvania	United States

Sponsors and Collaborators

• Johns Hopkins University
• National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00052078
• Other Study ID Numbers: U01MH064089; U01MH064089; DSIR 84-CTP
• First Posted: Jan 23, 2003
• Last Update Posted: Sep 19, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Johns Hopkins University: Phobic Disorders; Anxiety, Separation
• Additional relevant MeSH terms: Disease; Anxiety Disorders; Phobia, Social; Sertraline

Study Results

Participant Flow

Arm/Group Title	1 Setraline	2 CBT	3 Combination Setraline and CBT	4 Placebo
Arm/Group Description	Participants will receive sertraline for 12 weeks Sertraline: Participants will take sertraline for 12 weeks.	Participants will receive cognitive behavioral therapy for 12 weeks Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.	Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks Sertraline: Participants will take sertraline for 12 weeks. Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.	Participants will receive placebo for 12 weeks Placebo: Participants will take placebo capsules for 12 weeks.
Period Title: Overall Study
STARTED	133	139	140	76
COMPLETED	110	133	127	61
NOT COMPLETED	23	6	13	15

Baseline Characteristics

Arm/Group Title	1 Setraline	2 CBT	3 Combination Setraline and CBT	4 Placebo	Total
Arm/Group Description	Participants will receive sertraline for 12 weeks Sertraline: Participants will take sertraline for 12 weeks.	Participants will receive cognitive behavioral therapy for 12 weeks Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.	Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks Sertraline: Participants will take sertraline for 12 weeks. Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.	Participants will receive placebo for 12 weeks Placebo: Participants will take placebo capsules for 12 weeks.	Total of all reporting groups
Overall Participants	133	139	140	76	488
Age (Count of Participants)
<=18 years	133 100%	139 100%	140 100%	76 100%	488 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	61 45.9%	72 51.8%	72 51.4%	37 48.7%	242 49.6%
Male	72 54.1%	67 48.2%	68 48.6%	39 51.3%	246 50.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1.5%	3 2.2%	1 0.7%	0 0%	6 1.2%
Asian	4 3%	1 0.7%	6 4.3%	1 1.3%	12 2.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 0.7%	1 1.3%	2 0.4%
Black or African American	12 9%	14 10.1%	11 7.9%	7 9.2%	44 9%
White	103 77.4%	106 76.3%	116 82.9%	60 78.9%	385 78.9%
More than one race	12 9%	15 10.8%	5 3.6%	7 9.2%	39 8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	133 100%	139 100%	140 100%	76 100%	488 100%

Outcome Measures

1. Primary Outcome

Title	Clinical Global Impression - Improvement Scale
Description	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.
Time Frame	Measured at Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 Setraline	2 CBT	3 Combination Setraline and CBT	4 Placebo
Arm/Group Description	Participants will receive sertraline for 12 weeks Sertraline: Participants will take sertraline for 12 weeks.	Participants will receive cognitive behavioral therapy for 12 weeks Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.	Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks Sertraline: Participants will take sertraline for 12 weeks. Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.	Participants will receive placebo for 12 weeks Placebo: Participants will take placebo capsules for 12 weeks.
Measure Participants	133	139	140	76
Number (95% Confidence Interval) [percentage of participants]	54.9 41.3%	59.7 42.9%	80.7 57.6%	23.7 31.2%

Adverse Events

Arm/Group Title	1 Setraline		2 CBT		3 Combination Setraline + CBT		4 Placebo
Arm/Group Description	Participants will receive sertraline for 12 weeks Sertraline: Participants will take sertraline for 12 weeks.		Participants will receive cognitive behavioral therapy for 12 weeks Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.		Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks Sertraline: Participants will take sertraline for 12 weeks. Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.		Participants will receive placebo for 12 weeks Placebo: Participants will take placebo capsules for 12 weeks.
All Cause Mortality
	1 Setraline		2 CBT		3 Combination Setraline + CBT		4 Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	1 Setraline		2 CBT		3 Combination Setraline + CBT		4 Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/133 (1.5%)		0/139 (0%)		1/140 (0.7%)		0/76 (0%)
Psychiatric disorders
Worsening of Behavior	1/133 (0.8%)	1	0/139 (0%)	0	0/140 (0%)	0	0/76 (0%)	0
Oppositional-Defiant Behavior	0/133 (0%)	0	0/139 (0%)	0	1/140 (0.7%)	1	0/76 (0%)	0
Surgical and medical procedures
Tonsillectomy	1/133 (0.8%)	1	0/139 (0%)	0	0/140 (0%)	0	0/76 (0%)	0
Other (Not Including Serious) Adverse Events
	1 Setraline		2 CBT		3 Combination Setraline + CBT		4 Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/133 (0%)		0/139 (0%)		0/140 (0%)		0/76 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.