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

PTSD Clinical Trial

Official title:

Effect of D-cycloserine on Treatment of PTSD in Youth

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01157416
• Other study ID #: 1RC1MH088969-01
• Secondary ID: 1RC1MH088969-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 2, 2010
• Last updated: June 29, 2012
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Tulane University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorders
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• D-cycloserine
D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
• Placebo pill
Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.

Locations

Country	Name	City	State
United States	Tulane University Health Sciences Center, 1440 Canal St.	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of PTSD symptoms	Symptoms established from diagnostic interview.	After 12 therapy sessions.	No
Secondary	Attentional bias	Measured as reaction time on laptop computer by individuals response to pressing key to an asterisk appearing on the computer screen.	After 12 therapy sessions.	No