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Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01157416
First Posted: July 7, 2010
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michael S. Scheeringa, Tulane University School of Medicine
July 2, 2010
July 7, 2010
August 20, 2016
April 21, 2017
April 21, 2017
June 2010
June 2012   (Final data collection date for primary outcome measure)
Child PTSD Symptom Scale (CPSS) [ Time Frame: After 12 therapy sessions, up to 28 weeks. ]
The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).
Number of PTSD symptoms [ Time Frame: After 12 therapy sessions. ]
Symptoms established from diagnostic interview.
Complete list of historical versions of study NCT01157416 on ClinicalTrials.gov Archive Site
Not Provided
Attentional bias [ Time Frame: After 12 therapy sessions. ]
Measured as reaction time on laptop computer by individuals response to pressing key to an asterisk appearing on the computer screen.
Not Provided
Not Provided
 
Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth
Effect of D-cycloserine on Treatment of PTSD in Youth
The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 7-12 year old children.

While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show improvement, they still have some enduring symptoms and functional impairment. Accordingly, there is a need for treatment advances.

D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS was found to enhance learning and memory, and also facilitates extinction of fear reactions. However, DCS only produces an extinction effect when paired with behavioral training, not when simply given alone. Thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. The research also includes a three-month follow-up assessment.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorders
  • PTSD
  • Drug: D-cycloserine
    D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
    Other Name: Seromycin (brand name)
  • Drug: Placebo pill
    Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.
  • Behavioral: CBT
    12-session CBT protocol, called Youth PTSD Treatment.
    Other Name: cognitive behavioral therapy
  • Active Comparator: D-cycloserine plus CBT
    Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
    Interventions:
    • Drug: D-cycloserine
    • Behavioral: CBT
  • Placebo Comparator: Placebo plus CBT
    Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
    Interventions:
    • Drug: Placebo pill
    • Behavioral: CBT
Scheeringa MS, Weems CF. Randomized placebo-controlled D-cycloserine with cognitive behavior therapy for pediatric posttraumatic stress. J Child Adolesc Psychopharmacol. 2014 Mar;24(2):69-77. doi: 10.1089/cap.2013.0106. Epub 2014 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Certain number of PTSD symptoms plus functional impairment
  • Must be able to swallow pills

Exclusion Criteria:

  • Serious kidney or liver disease
  • Epilepsy
  • Bipolar
  • Psychosis
Sexes Eligible for Study: All
7 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01157416
1RC1MH088969-01( U.S. NIH Grant/Contract )
1RC1MH088969-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Michael S. Scheeringa, Tulane University School of Medicine
Tulane University School of Medicine
National Institute of Mental Health (NIMH)
Principal Investigator: Michael S Scheeringa, MD, MPH Tulane University School of Medicine
Tulane University
March 2017

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