Overview

This trial is active, not recruiting.

Conditions posttraumatic stress disorders, ptsd
Treatments d-cycloserine, placebo pill
Phase phase 2
Sponsor Tulane University School of Medicine
Collaborator National Institute of Mental Health (NIMH)
Start date June 2010
End date June 2012
Trial size 56 participants
Trial identifier NCT01157416, 1RC1MH088969-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
d-cycloserine Seromycin (brand name)
D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
(Placebo Comparator)
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
placebo pill
Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.

Primary Outcomes

Measure
Number of PTSD symptoms
time frame: After 12 therapy sessions.

Secondary Outcomes

Measure
Attentional bias
time frame: After 12 therapy sessions.

Eligibility Criteria

Male or female participants from 7 years up to 12 years old.

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

Additional Information

Official title Effect of D-cycloserine on Treatment of PTSD in Youth
Principal investigator Michael S Scheeringa, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Tulane University School of Medicine.