Posttraumatic Stress DisorderPhase 2NCT01157429
D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents
A Phase 2 study testing D-cycloserine and CBT in people with Posttraumatic Stress Disorder and PTSD, run by Tulane University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Posttraumatic Stress Disorder, PTSD
- What is being tested?
- D-cycloserine and CBT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Certain number of PTSD symptoms plus functional impairment
- Must be able to swallow pills
Who cannot join
- Serious kidney or liver disease
- Epilepsy
- Bipolar disorder
- Psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University Health Sciences Center, 1440 Canal St.
New Orleans, Louisiana, 70112
About this study
Official title: 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder, PTSD
- Being tested
- D-cycloserine, Placebo pill, CBT
- Keywords
- Cognitive Behavior Therapy, Children, Adolescents, Pharmacotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
Also called Seromycin
D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
Placebo pillDrug
Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol.
CBTBehavioural
Also called cognitive behavioral therapy
12-session CBT protocol, called Youth PTSD Treatment.
| Study group | Role | What they receive |
|---|---|---|
| D-cycloserine plus CBT | Active comparator | Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine. Receives: Drug: D-cycloserine; Behavioral: CBT |
| Placebo pill | Placebo comparator | Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill. Receives: Drug: Placebo pill; Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After 12 therapy sessions, up to 28 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Michael S. Scheeringa, Tulane University School of Medicine
- Investigators
- Michael S Scheeringa, MD, MPH, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157429
- Sponsor's protocol ID
- Tulane-09-00450
- Status last verified
- Apr 2017
- First submitted
- 6 Jul 2010
- Last updated
- 6 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 28569390Scheeringa 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.
PubMed 24506079
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-cycloserine Adjunctive Treatment for PTSD in Adolescents
- ClinicalTrials.gov ID
- NCT01157429
- Acronym / sponsor ID
- Tulane-09-00450
- Conditions
- Posttraumatic Stress Disorder, PTSD
- Keywords
- Cognitive Behavior Therapy, Children, Adolescents, Pharmacotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tulane University School of MedicineUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-cycloserine plus CBT | Active comparator | Drug: D-cycloserine, Behavioral: CBTIndividuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine. |
| Placebo pill | Placebo comparator | Drug: Placebo pill, Behavioral: CBTIndividuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Certain number of PTSD symptoms plus functional impairment
- Must be able to swallow pills
Key exclusion criteria (4 listed)
- Serious kidney or liver disease
- Epilepsy
- Bipolar disorder
- Psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-cycloserineAlso: SeromycinD-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol. | Drug | D-cycloserine plus CBT |
| Placebo pillPlacebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol. | Drug | Placebo pill |
| CBTAlso: cognitive behavioral therapy12-session CBT protocol, called Youth PTSD Treatment. | Behavioural | D-cycloserine plus CBT, Placebo pill |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28569390Scheeringa 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.
- Derived from this study: PubMed 24506079Scheeringa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Scheeringa, MD, MPH principal investigator
Tulane University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-cycloserine and CBT in people with Posttraumatic Stress Disorder and PTSD, run by Tulane University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child PTSD Symptom Scale (CPSS) (time frame: After 12 therapy sessions, up to 28 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157429, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.