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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michael S. Scheeringa, Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT01157416
First received: July 2, 2010
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorders
PTSD
 Drug: D-cycloserine
Drug: Placebo pill
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of D-cycloserine on Treatment of PTSD in Youth

Resource links provided by NLM:

Drug Information available for: Cycloserine
U.S. FDA Resources

Further study details as provided by Tulane University School of Medicine:

Primary Outcome Measures:
  • Number of PTSD symptoms [ Time Frame: After 12 therapy sessions. ] [ Designated as safety issue: No ]
    Symptoms established from diagnostic interview.


Secondary Outcome Measures:
  • Attentional bias [ Time Frame: After 12 therapy sessions. ] [ Designated as safety issue: No ]
    Measured as reaction time on laptop computer by individuals response to pressing key to an asterisk appearing on the computer screen.


Estimated Enrollment: 56
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: D-cycloserine plus CBT
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
 Drug: D-cycloserine
D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
Other Name: Seromycin (brand name)
Placebo Comparator: Placebo plus CBT
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
 Drug: Placebo pill
Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.

Detailed 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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157416

Locations
United States, Louisiana
Tulane University Health Sciences Center, 1440 Canal St.
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University School of Medicine
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Michael S Scheeringa, MD, MPH Tulane University School of Medicine
  More Information

No publications provided

Responsible Party: Michael S. Scheeringa, Professor, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT01157416     History of Changes
Other Study ID Numbers: 1RC1MH088969-01, 1RC1MH088969-01
Study First Received: July 2, 2010
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Tulane University School of Medicine:
Cognitive Behavior Therapy
Children
Pharmacotherapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013