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Child and Adolescent Anxiety Disorders (CAMS)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00052078
First received: January 22, 2003
Last updated: August 21, 2017
Last verified: August 2017
Results First Received: July 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Anxiety Disorders
Social Phobia
Generalized Anxiety Disorder
Interventions: Drug: Sertraline (SRT)
Behavioral: Cognitive Behavioral Therapy (CBT)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1 Setraline

Participants will receive sertraline for 12 weeks

Sertraline: Participants will take sertraline for 12 weeks.

2 CBT

Participants will receive cognitive behavioral therapy for 12 weeks

Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.

3 Combination Setraline and CBT

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.

4 Placebo

Participants will receive placebo for 12 weeks

Placebo: Participants will take placebo capsules for 12 weeks.


Participant Flow:   Overall Study
    1 Setraline   2 CBT   3 Combination Setraline and CBT   4 Placebo
STARTED   133   139   140   76 
COMPLETED   110   133   127   61 
NOT COMPLETED   23   6   13   15 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 Setraline

Participants will receive sertraline for 12 weeks

Sertraline: Participants will take sertraline for 12 weeks.

2 CBT

Participants will receive cognitive behavioral therapy for 12 weeks

Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.

3 Combination Setraline and CBT

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.

4 Placebo

Participants will receive placebo for 12 weeks

Placebo: Participants will take placebo capsules for 12 weeks.

Total Total of all reporting groups

Baseline Measures
   1 Setraline   2 CBT   3 Combination Setraline and CBT   4 Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 133   139   140   76   488 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      133 100.0%      139 100.0%      140 100.0%      76 100.0%      488 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
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) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      2   1.5%      3   2.2%      1   0.7%      0   0.0%      6   1.2% 
Asian      4   3.0%      1   0.7%      6   4.3%      1   1.3%      12   2.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      1   0.7%      1   1.3%      2   0.4% 
Black or African American      12   9.0%      14  10.1%      11   7.9%      7   9.2%      44   9.0% 
White      103  77.4%      106  76.3%      116  82.9%      60  78.9%      385  78.9% 
More than one race      12   9.0%      15  10.8%      5   3.6%      7   9.2%      39   8.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   133   139   140   76   488 


  Outcome Measures

1.  Primary:   Clinical Global Impression - Improvement Scale   [ Time Frame: Measured at Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: John Walkup
Organization: Johns Hopkins University
phone: 212-746-1891
e-mail: jtw9001@med.cornell.edu


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00052078     History of Changes
Other Study ID Numbers: U01MH064089 ( U.S. NIH Grant/Contract )
DSIR 84-CTP
Study First Received: January 22, 2003
Results First Received: July 29, 2016
Last Updated: August 21, 2017