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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


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
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