NCT01157416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

April 21, 2017

Completed
Last Updated

April 21, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

July 2, 2010

Results QC Date

August 20, 2016

Last Update Submit

March 10, 2017

Conditions

Posttraumatic Stress DisordersPTSD

Keywords

Cognitive Behavior TherapyChildrenPharmacotherapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    After 12 therapy sessions, up to 28 weeks.

Study Arms (2)

D-cycloserine plus CBT

ACTIVE COMPARATOR

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

Drug: D-cycloserineBehavioral: CBT

Placebo plus CBT

PLACEBO COMPARATOR

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

Drug: Placebo pillBehavioral: CBT

Interventions

D-cycloserineDRUG

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

Also known as: Seromycin (brand name)
D-cycloserine plus CBT
Placebo pillDRUG

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

Placebo plus CBT
CBTBEHAVIORAL

12-session CBT protocol, called Youth PTSD Treatment.

Also known as: cognitive behavioral therapy
D-cycloserine plus CBTPlacebo plus CBT

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Certain number of PTSD symptoms plus functional impairment
  • Must be able to swallow pills

You may not qualify if:

  • Serious kidney or liver disease
  • Epilepsy
  • Bipolar
  • Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane University Health Sciences Center, 1440 Canal St.

New Orleans, Louisiana, 70112, United States

Location

Related Publications (2)

  • 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.

    PMID: 28569390DERIVED

  • 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.

    PMID: 24506079DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

CycloserineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Michael Scheeringa
Organization
Tulane University School of Medicine
mscheer@tulane.edu
5046692322

Study Officials

  • Michael S Scheeringa, MD, MPH

    Tulane University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 7, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

April 21, 2017

Results First Posted

April 21, 2017

Record last verified: 2017-03

Locations

US(1)