Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (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.

• 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

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