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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01157416
Recruitment Status : Completed
First Posted : July 7, 2010
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michael S. Scheeringa, Tulane University School of Medicine

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorders PTSD Drug: D-cycloserine Drug: Placebo pill Behavioral: CBT Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of D-cycloserine on Treatment of PTSD in Youth
Study Start Date : June 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arms and Interventions
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Arm Intervention/treatment
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)

Behavioral: CBT
12-session CBT protocol, called Youth PTSD Treatment.
Other Name: cognitive behavioral therapy
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.

Behavioral: CBT
12-session CBT protocol, called Youth PTSD Treatment.
Other Name: cognitive behavioral therapy


Outcome Measures
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Primary Outcome Measures :
  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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157416


Locations
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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
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Principal Investigator: Michael S Scheeringa, MD, MPH Tulane University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael S. Scheeringa, Professor, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT01157416    
Other Study ID Numbers: 1RC1MH088969-01 ( U.S. NIH Grant/Contract )
1RC1MH088969-01 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2010    Key Record Dates
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: March 2017
Keywords provided by Michael S. Scheeringa, Tulane University School of Medicine:
Cognitive Behavior Therapy
Children
Pharmacotherapy
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
 Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action