Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth
Recruitment status was Active, not recruiting
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.
Posttraumatic Stress Disorders
Drug: Placebo pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of D-cycloserine on Treatment of PTSD in Youth|
- Number of PTSD symptoms [ Time Frame: After 12 therapy sessions. ] [ Designated as safety issue: No ]Symptoms established from diagnostic interview.
- 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.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: D-cycloserine plus CBT
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
Other Name: Seromycin (brand name)
Placebo Comparator: Placebo plus CBT
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Drug: Placebo pill
Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157416
|United States, Louisiana|
|Tulane University Health Sciences Center, 1440 Canal St.|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Michael S Scheeringa, MD, MPH||Tulane University School of Medicine|