- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01157429
D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents
April 25, 2017 updated by: Michael S. Scheeringa, Tulane University School of Medicine
D-cycloserine Adjunctive Treatment for PTSD in Adolescents
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane University Health Sciences Center, 1440 Canal St.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
Other Names:
12-session CBT protocol, called Youth PTSD Treatment.
Other Names:
|
Placebo Comparator: Placebo pill
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
|
12-session CBT protocol, called Youth PTSD Treatment.
Other Names:
Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
After 12 therapy sessions, up to 28 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
July 6, 2010
First Submitted That Met QC Criteria
July 6, 2010
First Posted (Estimate)
July 7, 2010
Study Record Updates
Last Update Posted (Actual)
June 6, 2017
Last Update Submitted That Met QC Criteria
April 25, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Trauma and Stressor Related Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antimetabolites
- Anti-Bacterial Agents
- Antitubercular Agents
- Antibiotics, Antitubercular
- Anti-Infective Agents, Urinary
- Renal Agents
- Cycloserine
Other Study ID Numbers
- Tulane-09-00450
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PTSD
-
University of PittsburghCompletedPTSD | Non PTSDUnited States
-
Imperial College Healthcare NHS TrustImperial College LondonRecruiting
-
VA Office of Research and DevelopmentUniversity of California, San DiegoRecruiting
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Active, not recruiting
-
Oregon Health and Science UniversityEnrolling by invitation
-
VA Office of Research and DevelopmentCompleted
-
VA Office of Research and DevelopmentPortland VA Medical CenterActive, not recruiting
-
VA Office of Research and DevelopmentSan Diego Veterans Healthcare SystemCompleted
-
Creighton UniversityCompleted
-
VA Eastern KansasTerminated
Clinical Trials on D-cycloserine
-
Mclean HospitalUniversity of MinnesotaCompletedSchizophrenia | Bipolar Disorder
-
University of Texas at AustinBoston University; Rush University Medical Center; Southern Methodist UniversityCompletedSocial Anxiety DisorderUnited States
-
University of OxfordNational Health Service, United KingdomUnknownChronic Obstructive Pulmonary DiseaseUnited Kingdom
-
Northwestern UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...TerminatedChronic Prostatitis With Chronic Pelvic Pain SyndromeUnited States
-
Yale UniversityCompletedAlcohol DependenceUnited States
-
University of California, Los AngelesUnknownTraumatic Brain InjuryUnited States
-
US Department of Veterans AffairsCompleted
-
University of ArkansasNational Institute on Drug Abuse (NIDA)Completed
-
Northwestern UniversityTerminatedPain | Breast Cancer | NeurotoxicityUnited States
-
Hoffmann-La RocheCompletedHepatitis C, ChronicNew Zealand, Australia