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Completed

NCT Number: NCT01157416

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

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.

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Key information

Conditions

Posttraumatic Stress Disorders Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tulane University Health Sciences Center, 1440 Canal St.

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-cycloserine

Drug

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

Other names: Seromycin (brand name)

Placebo pill

Drug

Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.

CBT

Behavioral

12-session CBT protocol, called Youth PTSD Treatment.

Other names: cognitive behavioral therapy

Primary outcomes

  1. Child PTSD Symptom Scale (CPSS)

    Time frame: After 12 therapy sessions, up to 28 weeks.

    The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).

Sponsors and collaborators

Lead sponsor

Tulane University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Effect of D-cycloserine on Treatment of PTSD in Youth

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 7, 2010
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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