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D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents

Primary Purpose

Posttraumatic Stress Disorder, PTSD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
D-cycloserine
Placebo pill
CBT
Sponsored by
Tulane University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Cognitive Behavior Therapy, Children, Adolescents, Pharmacotherapy

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept 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 disorder
  • Psychosis

Sites / Locations

  • Tulane University Health Sciences Center, 1440 Canal St.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

D-cycloserine plus CBT

Placebo pill

Arm Description

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

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

Outcomes

Primary Outcome Measures

Child PTSD Symptom Scale (CPSS)
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).

Secondary Outcome Measures

Full Information

First Posted
July 6, 2010
Last Updated
April 25, 2017
Sponsor
Tulane University School of Medicine
Collaborators
National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT01157429
Brief Title
D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents
Official Title
D-cycloserine Adjunctive Treatment for PTSD in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University School of Medicine
Collaborators
National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 13-18 year-old children.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, PTSD
Keywords
Cognitive Behavior Therapy, Children, Adolescents, Pharmacotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-cycloserine plus CBT
Arm Type
Active Comparator
Arm Description
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Arm Description
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Intervention Type
Drug
Intervention Name(s)
D-cycloserine
Other Intervention Name(s)
Seromycin
Intervention Description
D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
Intervention Type
Drug
Intervention Name(s)
Placebo pill
Intervention Description
Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
cognitive behavioral therapy
Intervention Description
12-session CBT protocol, called Youth PTSD Treatment.
Primary Outcome Measure Information:
Title
Child PTSD Symptom Scale (CPSS)
Description
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).
Time Frame
After 12 therapy sessions, up to 28 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 disorder Psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Scheeringa, MD, MPH
Organizational Affiliation
Tulane University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane University Health Sciences Center, 1440 Canal St.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28569390
Citation
Scheeringa MS, Lilly ME, Staiger AB, Heller ML, Jones EG, Weems CF. Do Children and Adolescents Have Different Types of Trauma Narratives and Does It Matter? Reliability and Face Validation for a Narrative Taxonomy. J Trauma Stress. 2017 Jun;30(3):323-327. doi: 10.1002/jts.22190. Epub 2017 Jun 1.
Results Reference
derived
PubMed Identifier
24506079
Citation
Scheeringa MS, Weems CF. Randomized placebo-controlled D-cycloserine with cognitive behavior therapy for pediatric posttraumatic stress. J Child Adolesc Psychopharmacol. 2014 Mar;24(2):69-77. doi: 10.1089/cap.2013.0106. Epub 2014 Feb 7.
Results Reference
derived

Learn more about this trial

D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents

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