NCT00382291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
2.3 years until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 12, 2013

Completed
Last Updated

March 12, 2013

Status Verified

December 1, 2012

Enrollment Period

2 years

First QC Date

September 28, 2006

Results QC Date

December 14, 2012

Last Update Submit

February 6, 2013

Conditions

Obsessive-Compulsive Disorder

Keywords

OCDAntidepressive Agents, Second-GenerationPlacebosCognitive Behavior TherapyChild PsychiatryActivation SyndromePsychometrics

Outcome Measures

Primary Outcomes (2)

  • Clinical Global Impression - Severity of Activation (CGI-SA)

    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.

    Measured at screening, baseline and weekly until end of week 8 after baseline, then monthly for two months and finally at end of study

  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score

    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).

    Measured at Week 18 or End of Study

Study Arms (3)

Regular Titration

EXPERIMENTAL

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.

Drug: Regular Titration

Placebo

PLACEBO COMPARATOR

Placebo plus cognitive behavioral therapy

Drug: Placebo

Slow Titration

EXPERIMENTAL

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.

Drug: Slow Titration

Interventions

Regular TitrationDRUG

Sertraline will be administered in standard dosing. Treatment with sertraline will last 18 weeks.

Regular Titration
PlaceboDRUG

The placebo will be administered in the same manner as sertraline. Treatment with placebo will last 18 weeks.

Placebo
Slow TitrationDRUG

Sertraline will be administered in slow titration. Treatment with sertraline will last 18 weeks.

Slow Titration

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of South Florida

Tampa, Florida, 33701, United States

Location

Related Publications (4)

  • Bussing R, Murphy TK, Storch EA, McNamara JP, Reid AM, Garvan CW, Goodman WK. Psychometric properties of the Treatment-Emergent Activation and Suicidality Assessment Profile (TEASAP) in youth with OCD. Psychiatry Res. 2013 Feb 28;205(3):253-61. doi: 10.1016/j.psychres.2012.09.019. Epub 2012 Sep 29.

    PMID: 23031804RESULT

  • Reid AM, McNamara JP, Murphy TK, Guzick AG, Storch EA, Goodman WK, Geffken GR, Bussing R. Side-effects of SSRIs disrupt multimodal treatment for pediatric OCD in a randomized-controlled trial. J Psychiatr Res. 2015 Dec;71:140-7. doi: 10.1016/j.jpsychires.2015.10.006. Epub 2015 Oct 14.

    PMID: 26495770DERIVED

  • Bussing R, Reid AM, McNamara JP, Meyer JM, Guzick AG, Mason DM, Storch EA, Murphy TK. A pilot study of actigraphy as an objective measure of SSRI activation symptoms: results from a randomized placebo controlled psychopharmacological treatment study. Psychiatry Res. 2015 Feb 28;225(3):440-5. doi: 10.1016/j.psychres.2014.11.070. Epub 2014 Dec 10.

    PMID: 25535011DERIVED

  • Storch EA, Bussing R, Small BJ, Geffken GR, McNamara JP, Rahman O, Lewin AB, Garvan CS, Goodman WK, Murphy TK. Randomized, placebo-controlled trial of cognitive-behavioral therapy alone or combined with sertraline in the treatment of pediatric obsessive-compulsive disorder. Behav Res Ther. 2013 Dec;51(12):823-9. doi: 10.1016/j.brat.2013.09.007. Epub 2013 Oct 10.

    PMID: 24184429DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Limitations and Caveats

Temporary study suspension led to smaller number of subjects enrolled than initially planned and resulted in smaller number of subjects analyzed, reducing power.

Results Point of Contact

Title
Dr. Regina Bussing
Organization
University of Florida
rbussing@ufl.edu
(352) 273-7550

Study Officials

  • Tanya K. Murphy, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

  • Regina Bussing, M.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 12, 2013

Results First Posted

March 12, 2013

Record last verified: 2012-12

Locations

US(2)