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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Tulane University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael S. Scheeringa, Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT01157416
First received: July 2, 2010
Last updated: June 29, 2012
Last verified: June 2012

July 2, 2010
June 29, 2012
June 2010
June 2012   (final data collection date for primary outcome measure)
Number of PTSD symptoms [ Time Frame: After 12 therapy sessions. ] [ Designated as safety issue: No ]
Symptoms established from diagnostic interview.
Same as current
Complete list of historical versions of study NCT01157416 on ClinicalTrials.gov Archive Site
Attentional bias [ Time Frame: After 12 therapy sessions. ] [ Designated as safety issue: No ]
Measured as reaction time on laptop computer by individuals response to pressing key to an asterisk appearing on the computer screen.
Same as current
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 alone 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
  • Active Comparator: D-cycloserine plus CBT
    Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
    Intervention: Drug: D-cycloserine
  • Placebo Comparator: Placebo plus CBT
    Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
    Intervention: Drug: Placebo pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
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
Both
7 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01157416
1RC1MH088969-01, 1RC1MH088969-01
Yes
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 School of Medicine
June 2012

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