Trial Outcomes & Findings for Child and Adolescent Anxiety Disorders (CAMS) (NCT NCT00052078)
NCT ID: NCT00052078
Last Updated: 2017-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
488 participants
Primary outcome timeframe
Measured at Week 12
Results posted on
2017-09-19
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
133
|
139
|
140
|
76
|
|
Overall Study
COMPLETED
|
110
|
133
|
127
|
61
|
|
Overall Study
NOT COMPLETED
|
23
|
6
|
13
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Child and Adolescent Anxiety Disorders (CAMS)
Baseline characteristics by cohort
| Measure |
1 Setraline
n=133 Participants
Participants will receive sertraline for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks.
|
2 CBT
n=139 Participants
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
n=140 Participants
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
n=76 Participants
Participants will receive placebo for 12 weeks
Placebo: Participants will take placebo capsules for 12 weeks.
|
Total
n=488 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
133 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
488 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
242 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
246 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
385 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
133 participants
n=5 Participants
|
139 participants
n=7 Participants
|
140 participants
n=5 Participants
|
76 participants
n=4 Participants
|
488 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at Week 12The 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.
Outcome measures
| Measure |
1 Setraline
n=133 Participants
Participants will receive sertraline for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks.
|
2 CBT
n=139 Participants
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
n=140 Participants
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
n=76 Participants
Participants will receive placebo for 12 weeks
Placebo: Participants will take placebo capsules for 12 weeks.
|
|---|---|---|---|---|
|
Clinical Global Impression - Improvement Scale
|
54.9 percentage of participants
Interval 46.4 to 63.1
|
59.7 percentage of participants
Interval 51.4 to 67.5
|
80.7 percentage of participants
Interval 73.3 to 86.4
|
23.7 percentage of participants
Interval 15.5 to 34.5
|
Adverse Events
1 Setraline
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
2 CBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Combination Setraline + CBT
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
4 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Setraline
n=133 participants at risk
Participants will receive sertraline for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks.
|
2 CBT
n=139 participants at risk
Participants will receive cognitive behavioral therapy for 12 weeks
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks.
|
3 Combination Setraline + CBT
n=140 participants at risk
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
n=76 participants at risk
Participants will receive placebo for 12 weeks
Placebo: Participants will take placebo capsules for 12 weeks.
|
|---|---|---|---|---|
|
Psychiatric disorders
Worsening of Behavior
|
0.75%
1/133 • Number of events 1
|
0.00%
0/139
|
0.00%
0/140
|
0.00%
0/76
|
|
Psychiatric disorders
Oppositional-Defiant Behavior
|
0.00%
0/133
|
0.00%
0/139
|
0.71%
1/140 • Number of events 1
|
0.00%
0/76
|
|
Surgical and medical procedures
Tonsillectomy
|
0.75%
1/133 • Number of events 1
|
0.00%
0/139
|
0.00%
0/140
|
0.00%
0/76
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place