Trial Outcomes & Findings for Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder (NCT NCT00382291)
NCT ID: NCT00382291
Last Updated: 2013-03-12
Results Overview
The CGI-SA was adapted from the Clinical Global Impressions - Severity of Illness (CGI-SI) rating (Guy, 1976). The CGI-SI is commonly used in clinical studies of children and adults and has been extensively validated (Zaider et al., 2003). On the CGI-SA clinicians rate the severity of activation symptoms on a range from 0 (no activation) to 7 (extremely severe symptoms, functionally highly impaired and/or extreme distress). We report values representing Median+/-Std Dev for the maximum CGI-SA obtained over the course of study.
COMPLETED
PHASE4
56 participants
Measured at screening, baseline and weekly until end of week 8 after baseline, then monthly for two months and finally at end of study
2013-03-12
Participant Flow
The study was performed at two child and adolescent psychiatric clinics within university medical centers: Gainesville, Florida (FL) (UF) and Tampa, FL (USF). Recruitment started in early 2009 and ended in late 2010.
Fifteen participants were excluded after screening: 7/15 did not meet inclusion/exclusion criteria and 8/15 withdrew consent.
Participant milestones
| Measure |
Placebo Plus CBT
Placebo plus cognitive behavior therapy (CBT).
|
Regular Sertraline Titration Plus CBT
Regular titration of sertraline (RegSert) plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
|
Slow Sertraline Titration Plus CBT
Slow titration of sertraline (SloSert)plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
21
|
|
Overall Study
COMPLETED
|
14
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
8
|
Reasons for withdrawal
| Measure |
Placebo Plus CBT
Placebo plus cognitive behavior therapy (CBT).
|
Regular Sertraline Titration Plus CBT
Regular titration of sertraline (RegSert) plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
|
Slow Sertraline Titration Plus CBT
Slow titration of sertraline (SloSert)plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Temporary study suspension
|
2
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
Baseline Characteristics
Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Placebo plus cognitive behavior therapy.
|
Regular Titration
n=17 Participants
Regular titration of sertraline plus cognitive behavior therapy.
|
Slow Titration
n=21 Participants
Slow titration of sertraline plus cognitive behavior therapy.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
56 Participants
n=4 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
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at screening, baseline and weekly until end of week 8 after baseline, then monthly for two months and finally at end of studyPopulation: Per protocol, Intent to treat
The CGI-SA was adapted from the Clinical Global Impressions - Severity of Illness (CGI-SI) rating (Guy, 1976). The CGI-SI is commonly used in clinical studies of children and adults and has been extensively validated (Zaider et al., 2003). On the CGI-SA clinicians rate the severity of activation symptoms on a range from 0 (no activation) to 7 (extremely severe symptoms, functionally highly impaired and/or extreme distress). We report values representing Median+/-Std Dev for the maximum CGI-SA obtained over the course of study.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo plus cognitive behavior therapy.
|
Regular Titration
n=17 Participants
Regular titration of sertraline plus cognitive behavior therapy.
|
Slow Titration
n=21 Participants
Slow titration of sertraline plus cognitive behavior therapy.
|
|---|---|---|---|
|
Clinical Global Impression - Severity of Activation (CGI-SA)
|
.50 units on a scale
Standard Deviation 1.50
|
2.00 units on a scale
Standard Deviation 1.35
|
2.00 units on a scale
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: Measured at Week 18 or End of StudyThe CY-BOCS (Scahill et al., 1997) is a semi-structured, clinician rated instrument to measure OCD symptom severity in youth. The CY-BOCS contains a symptom checklist and a severity scale. Through the symptom checklist the clinician assesses current and past experiences of over 60 potential obsessions and compulsions. The Total Score represents the sum of obsession severity and compulsion severity which each consist of five clinician ratings on a Likert scale (range from 0 (none) to 4 (extreme), for time spent, interference, distress, resistance and control over symptoms). Summing of obsession and compulsion severity (range 0-20 on each) produces the Total CY-BOCS score (range 0-40, with 0 representing the best and 40 the worst outcome). Studies have documented good psychometric properties of the CY-BOCS (Gallant et al., 2008; Scahill et al., 1997; Storch et al., 2004).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo plus cognitive behavior therapy.
|
Regular Titration
n=17 Participants
Regular titration of sertraline plus cognitive behavior therapy.
|
Slow Titration
n=21 Participants
Slow titration of sertraline plus cognitive behavior therapy.
|
|---|---|---|---|
|
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score
|
16.28 units on a scale
Standard Deviation 7.11
|
16.35 units on a scale
Standard Deviation 9.60
|
17.67 units on a scale
Standard Deviation 7.28
|
Adverse Events
Placebo
Regular Titration
Slow Titration
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo plus cognitive behavior therapy.
|
Regular Titration
n=17 participants at risk
Regular titration of sertraline plus cognitive behavior therapy.
|
Slow Titration
n=21 participants at risk
Slow titration of sertraline plus cognitive behavior therapy.
|
|---|---|---|---|
|
Psychiatric disorders
Depersonalization
|
0.00%
0/18 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
5.9%
1/17 • Number of events 1 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
0.00%
0/21 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.6%
1/18 • Number of events 1 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
0.00%
0/17 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
0.00%
0/21 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo plus cognitive behavior therapy.
|
Regular Titration
n=17 participants at risk
Regular titration of sertraline plus cognitive behavior therapy.
|
Slow Titration
n=21 participants at risk
Slow titration of sertraline plus cognitive behavior therapy.
|
|---|---|---|---|
|
Nervous system disorders
Insomnia
|
16.7%
3/18 • Number of events 10 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
47.1%
8/17 • Number of events 12 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
28.6%
6/21 • Number of events 8 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
|
Nervous system disorders
Headache
|
50.0%
9/18 • Number of events 12 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
52.9%
9/17 • Number of events 24 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
57.1%
12/21 • Number of events 27 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
|
Gastrointestinal disorders
diarrhea
|
11.1%
2/18 • Number of events 3 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
29.4%
5/17 • Number of events 8 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
38.1%
8/21 • Number of events 14 • For individual study participants Adverse Events were collected from point of informed consent to end of study (up to 19 weeks plus required wash-out periods for completers). For the entire study adverse events were collected from 2/09 to 2/11.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place