A Phase 3 interventional study of Sertraline (SRT) and Cognitive Behavioral Therapy (CBT) in Anxiety Disorders, Social Phobia and Generalized Anxiety Disorder, sponsored by Johns Hopkins University. Completed at 6 sites in United States. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-19.
Sponsored by Johns Hopkins University · Phase 3, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 488 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received sertraline for 12 weeks.
Drug: Sertraline (SRT)
Participants received cognitive behavioral therapy for 12 weeks
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants received both sertraline and CBT for 12 weeks.
Drug: Sertraline (SRT) · Behavioral: Cognitive Behavioral Therapy (CBT)
Participants received a placebo pill for 12 weeks.
Drug: Placebo
Participants were treated with sertraline.
Also known as: Zoloft
Participants received CBT.
Participants were treated with a placebo pill.
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.
Time frame: Measured at Week 12
| Milestone | 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 |
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.
| percentage of participants | 1 Setraline | 2 CBT | 3 Combination Setraline and CBT | 4 Placebo |
|---|---|---|---|---|
| Clinical Global Impression - Improvement Scale | 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) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 Setraline | — | 2/133 (1.5%) | 0/133 (0%) |
| 2 CBT | — | 0/139 (0%) | 0/139 (0%) |
| 3 Combination Setraline + CBT | — | 1/140 (0.7%) | 0/140 (0%) |
| 4 Placebo | — | 0/76 (0%) | 0/76 (0%) |
| Event | 1 Setraline | 2 CBT | 3 Combination Setraline + CBT | 4 Placebo |
|---|---|---|---|---|
| Worsening of BehaviorPsychiatric disorders | 1/133 | 0/139 | 0/140 | 0/76 |
| TonsillectomySurgical and medical procedures | 1/133 | 0/139 | 0/140 | 0/76 |
| Oppositional-Defiant BehaviorPsychiatric disorders | 0/133 | 0/139 | 1/140 | 0/76 |
| Age, Categorical(Participants) | 1 Setraline | 2 CBT | 3 Combination Setraline and CBT | 4 Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 133 | 139 | 140 | 76 | 488 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 1 Setraline | 2 CBT | 3 Combination Setraline and CBT | 4 Placebo | Total |
|---|---|---|---|---|---|
| Female | 61 | 72 | 72 | 37 | 242 |
| Male | 72 | 67 | 68 | 39 | 246 |
| Race (NIH/OMB)(Participants) | 1 Setraline | 2 CBT | 3 Combination Setraline and CBT | 4 Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 3 | 1 | 0 | 6 |
| Asian | 4 | 1 | 6 | 1 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 | 2 |
| Black or African American | 12 | 14 | 11 | 7 | 44 |
| White | 103 | 106 | 116 | 60 | 385 |
| More than one race | 12 | 15 | 5 | 7 | 39 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | 1 Setraline | 2 CBT | 3 Combination Setraline and CBT | 4 Placebo | Total |
|---|---|---|---|---|---|
| United States | 133 | 139 | 140 | 76 | 488 |
Plan to share: Yes
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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