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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC1MH088969-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-cycloserine plus CBT | Active Comparator | Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine. |
|
| Placebo plus CBT | Placebo Comparator | Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-cycloserine | Drug | D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Scheeringa, MD, MPH | Tulane University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University Health Sciences Center, 1440 Canal St. | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28569390 | Derived | 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. | |
| 24506079 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | D-cycloserine Plus CBT | Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine. D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol. |
| FG001 | Placebo Plus CBT | Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill. Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | D-cycloserine Plus CBT | Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine. D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol. |
| BG001 | Placebo Plus CBT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | After 12 therapy sessions, up to 28 weeks. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-cycloserine Plus CBT | Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine. D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| drowsy | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Scheeringa | Tulane University School of Medicine | 5046692322 | mscheer@tulane.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo pill | Drug | Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol. |
|
| CBT | Behavioral | 12-session CBT protocol, called Youth PTSD Treatment. |
|
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Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill. Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.
|
|
| 0 |
| 17 |
| 6 |
| 17 |
| EG001 | Placebo Plus CBT | Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill. Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol. | 0 | 16 | 6 | 16 |
| headache | Nervous system disorders | Systematic Assessment |
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| angry | Nervous system disorders | Systematic Assessment |
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| dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| aggressive | Nervous system disorders | Systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| racing thoughts | Nervous system disorders | Systematic Assessment |
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| dizzy | Nervous system disorders | Systematic Assessment |
|
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |