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Trial record 43 of 1478 for:    child psychiatry

Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT00382291
Recruitment Status : Completed
First Posted : September 29, 2006
Results First Posted : March 12, 2013
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Obsessive-Compulsive Disorder
Interventions Drug: Regular Titration
Drug: Placebo
Drug: Slow Titration
Enrollment 56
Recruitment Details 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.
Pre-assignment Details Fifteen participants were excluded after screening: 7/15 did not meet inclusion/exclusion criteria and 8/15 withdrew consent.
Arm/Group Title Placebo Plus CBT Regular Sertraline Titration Plus CBT Slow Sertraline Titration Plus CBT
Hide Arm/Group Description Placebo plus cognitive behavior therapy (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 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.
Period Title: Overall Study
Started 18 17 21
Completed 14 10 13
Not Completed 4 7 8
Reason Not Completed
Adverse Event             1             2             2
Protocol Violation             1             0             0
Temporary study suspension             2             2             5
Withdrawal by Subject             0             2             0
Physician Decision             0             1             0
Lack of Efficacy             0             0             1
Arm/Group Title Placebo Regular Titration Slow Titration Total
Hide Arm/Group Description Placebo plus cognitive behavior therapy. Regular titration of sertraline plus cognitive behavior therapy. Slow titration of sertraline plus cognitive behavior therapy. Total of all reporting groups
Overall Number of Baseline Participants 18 17 21 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 21 participants 56 participants
<=18 years
18
 100.0%
17
 100.0%
21
 100.0%
56
 100.0%
Between 18 and 65 years
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%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 21 participants 56 participants
Female
7
  38.9%
7
  41.2%
8
  38.1%
22
  39.3%
Male
11
  61.1%
10
  58.8%
13
  61.9%
34
  60.7%
1.Primary Outcome
Title Clinical Global Impression – Severity of Activation (CGI-SA)
Hide Description 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.
Time Frame Measured at screening, baseline and weekly until end of week 8 after baseline, then monthly for two months and finally at end of study
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, Intent to treat
Arm/Group Title Placebo Regular Titration Slow Titration
Hide Arm/Group Description:
Placebo plus cognitive behavior therapy.
Regular titration of sertraline plus cognitive behavior therapy.
Slow titration of sertraline plus cognitive behavior therapy.
Overall Number of Participants Analyzed 18 17 21
Median (Standard Deviation)
Unit of Measure: units on a scale
.50  (1.50) 2.00  (1.35) 2.00  (1.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Regular Titration, Slow Titration
Comments Data were analyzed using two-sided Kruskal-Wallis test with level of significance = .05. Null hypothesis was that there were no group differences. The maximum CGI-SA obtained over course of study was the outcome measure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .2106
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Primary Outcome
Title Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score
Hide Description The 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).
Time Frame Measured at Week 18 or End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Regular Titration Slow Titration
Hide Arm/Group Description:
Placebo plus cognitive behavior therapy.
Regular titration of sertraline 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 titration of sertraline 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 Number of Participants Analyzed 18 17 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.28  (7.11) 16.35  (9.60) 17.67  (7.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Regular Titration, Slow Titration
Comments Data were analyzed using ANCOVA modeling with two-sided testing and level of significance = .05. The dependent variable was last measured CY-BOCS score, the independent variable was randomized group assignment and the covariate was the CY-BOCS score at baseline. The null hypothesis was that there were no group differences.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .8831
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Regular Titration Slow Titration
Hide Arm/Group Description Placebo plus cognitive behavior therapy. Regular titration of sertraline plus cognitive behavior therapy. Slow titration of sertraline plus cognitive behavior therapy.
All-Cause Mortality
Placebo Regular Titration Slow Titration
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Regular Titration Slow Titration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      1/17 (5.88%)      0/21 (0.00%)    
Psychiatric disorders       
Depersonalization * 1  0/18 (0.00%)  0 1/17 (5.88%)  1 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonia * 2  1/18 (5.56%)  1 0/17 (0.00%)  0 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Pulmonary
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Regular Titration Slow Titration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/18 (61.11%)      12/17 (70.59%)      18/21 (85.71%)    
Gastrointestinal disorders       
diarrhea * 1  2/18 (11.11%)  3 5/17 (29.41%)  8 8/21 (38.10%)  14
Nervous system disorders       
Insomnia * 1  3/18 (16.67%)  10 8/17 (47.06%)  12 6/21 (28.57%)  8
Headache * 1  9/18 (50.00%)  12 9/17 (52.94%)  24 12/21 (57.14%)  27
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Temporary study suspension led to smaller number of subjects enrolled than initially planned and resulted in smaller number of subjects analyzed, reducing power.
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: Dr. Regina Bussing
Organization: University of Florida
Phone: (352) 273-7550
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00382291     History of Changes
Other Study ID Numbers: R01MH078594 ( U.S. NIH Grant/Contract )
R01MH078594 ( U.S. NIH Grant/Contract )
DSIR 84-CTM
First Submitted: September 28, 2006
First Posted: September 29, 2006
Results First Submitted: December 14, 2012
Results First Posted: March 12, 2013
Last Update Posted: March 12, 2013