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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

Tracking Information
First Submitted Date  ICMJE September 28, 2006
First Posted Date  ICMJE September 29, 2006
Results First Submitted Date  ICMJE December 14, 2012
Results First Posted Date  ICMJE March 12, 2013
Last Update Posted Date March 12, 2013
Study Start Date  ICMJE February 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
  • Clinical Global Impression - Severity of Activation (CGI-SA) [ 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 ]
    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.
  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score [ Time Frame: Measured at Week 18 or End of Study ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2006)
Our primary comparison of interest will be the performance of the sertraline at standard dosing and placebo groups on both the TE-ASAP and existing behavioral measures of irritability, impulsivity/aggression, restlessness and mania.
Change History Complete list of historical versions of study NCT00382291 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2006)
We will explore if sertraline slowly increased reduces the frequency or intensity of activation syndrome compared to sertraline at standard dosing.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder
Official Title  ICMJE SSRI-Induced Activation Syndrome in Pediatric Obsessive Compulsive Disorder
Brief Summary This study measures the occurrence of certain side effects linked to antidepressant use and evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to treat people with obsessive-compulsive disorder.
Detailed Description

Obsessive-compulsive disorder (OCD) is an anxiety disorder that is associated with recurring repetitive behaviors and persistent unwanted thoughts. People with OCD often carry out ritual-like behaviors such as counting, cleaning, or washing their hands in order to momentarily ease their anxiety. A current treatment for people with OCD is the class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). A recent re-analysis of clinical trials on children with psychiatric conditions found that the risk of suicidal thoughts and behavior when on SSRI-antidepressants was considerably higher than when on placebo. The data also revealed that antidepressant-associated suicidal behavior was not limited to children with depression, but also affected children with OCD and other anxiety disorders. Although the process responsible for increased suicidality is unknown, it may be initiated by a set of symptoms collectively called SSRI induced activation syndrome, which is thought to be common, particularly in children and teens. However, there is a lack of knowledge on this syndrome, including its role in suicidal behavior and how it can be prevented. This study will evaluate a new behavioral test to measure certain side effects linked to antidepressant use. This study will also evaluate the effectiveness of the SSRI sertraline plus cognitive behavioral therapy (CBT) to treat people with OCD.

Potential participants will undergo an initial screening visit that will include an interview on psychological symptoms associated with OCD and possible family history of OCD. Eligible participants will then undergo a physical exam, blood draw, DNA sampling, and pregnancy test if applicable. Participants will be randomly assigned to receive either sertraline or placebo daily for 18 weeks. At weekly study visits, participants will receive their study drug, complete questionnaires about symptoms of OCD, and undergo vital sign measurements. At specified visits, participants will also perform a task (Stop Signal Task) on a computerized assessment device to measure attention and impulse control and may have blood drawn. For the first 4 weeks participants will wear a wristwatch-like device (actigraph) to monitor sleep patterns. During the first three visits, participants will receive supportive psychotherapy. At Visit 4, participants will begin receiving 60-minute CBT sessions, which will continue until the final visit. The final visit will include a second physical exam, questionnaires, and blood testing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Drug: Regular Titration
    Sertraline will be administered in standard dosing. Treatment with sertraline will last 18 weeks.
  • Drug: Placebo
    The placebo will be administered in the same manner as sertraline. Treatment with placebo will last 18 weeks.
  • Drug: Slow Titration
    Sertraline will be administered in slow titration. Treatment with sertraline will last 18 weeks.
Study Arms  ICMJE
  • Experimental: Regular Titration
    Regular titration of Sertraline plus cognitive behavioral 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.
    Intervention: Drug: Regular Titration
  • Placebo Comparator: Placebo
    Placebo plus cognitive behavioral therapy
    Intervention: Drug: Placebo
  • Experimental: Slow Titration
    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.
    Intervention: Drug: Slow Titration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2012)
56
Original Enrollment  ICMJE
 (submitted: September 28, 2006)
140
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Principal diagnosis of OCD with at least a 6-month duration, as determined by structured clinical interview (schedule for affective disorders and schizophrenia for school-age children)
  • As long as OCD is the principal diagnosis, co-morbid depression, attention deficit hyperactivity disorder, tic disorder, or another anxiety disorder is allowable
  • Diagnosis of trichotillomania or body dysmorphic disorder provided OCD symptoms are the predominant presenting features
  • Meets clinical criteria for Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) (e.g., abrupt onset and dramatic fluctuations in symptoms)

Exclusion Criteria:

  • Prior adequate trial of sertraline
  • Allergy to sertraline
  • History of rheumatic fever or serious autoimmune disorder
  • Diagnosis of bipolar disorder, autism, schizophrenia, mental retardation, or chronic degenerative neurological disease
  • Current anorexia nervosa with symptoms of body image distortion (symptoms of anorexia secondary to obsessions [e.g., contamination] are permitted)
  • Unable to safely swallow study medication after pill swallowing education
  • Unwillingness of children's parents to commit to accompanying their child for multiple study visits and to be responsible for medication compliance
  • Suicidal intent (suicidal ideation will not be an automatic exclusion; however, risk will be gauged carefully and the participant must contract for safety)
  • Suicide attempt in the 12 months prior to study entry
  • Pregnancy
  • Taking monoamine oxidase inhibitors (MAOIs) within 4 weeks of study entry or fluoxetine within 5 weeks of study entry
  • Taking other psychotropic medications other than sedative or hypnotics for insomnia
  • Substance abuse or dependence within 6 months prior to study entry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00382291
Other Study ID Numbers  ICMJE R01MH078594( U.S. NIH Grant/Contract )
R01MH078594 ( U.S. NIH Grant/Contract )
DSIR 84-CTM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Tanya K. Murphy, MD University of South Florida
Principal Investigator: Regina Bussing, M.D. University of Florida
PRS Account University of Florida
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP