NCT01157416

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

Effect of D-cycloserine on Treatment of PTSD in Youth

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Tulane University School of Medicine · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Posttraumatic Stress Disorders
• PTSD

Interventions

Type	Name	Description
DRUG	D-cycloserine	D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-07-07
• Last updated: 2017-04-21
• Results posted: 2017-04-21

Locations

1 site across 1 country: United States