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

Tulane University School of Medicine

Status and phase: Completed; Phase 2

Conditions: PTSD; Posttraumatic Stress Disorders

Treatments: Drug: D-cycloserine; Behavioral: CBT; Drug: Placebo pill

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01157416

1RC1MH088969-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

33 participants in 2 patient groups, including a placebo group

D-cycloserine plus CBT

Active Comparator group

Description:

Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.

Treatment:

Behavioral: CBT

Drug: D-cycloserine

Placebo plus CBT

Placebo Comparator group

Description:

Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.

Treatment:

Drug: Placebo pill

Behavioral: CBT