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Trial record 36 of 121 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

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

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ClinicalTrials.gov Identifier: NCT01157429
Recruitment Status : Completed
First Posted : July 7, 2010
Results First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Michael S. Scheeringa, Tulane University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Posttraumatic Stress Disorder
PTSD
Interventions Drug: D-cycloserine
Drug: Placebo pill
Behavioral: CBT
Enrollment 24
Recruitment Details  
Pre-assignment Details A total of 63 youth were assessed. Only 47 meet all the inclusion and exclusion criteria and were offered treatment. Of those 47, only 24 were retained through session 5 of the treatment, which was the point of random allocation. Twenty-three subjects of the 47 subjects who were offered treatment dropped out prior to session 5.
Arm/Group Title D-cycloserine Plus CBT Placebo Pill
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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.

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.

Period Title: Overall Study
Started 12 12
Completed 8 8
Not Completed 4 4
Arm/Group Title D-cycloserine Plus CBT Placebo Pill Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
15.7  (1.6) 15.9  (1.7) 15.8  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
10
  83.3%
7
  58.3%
17
  70.8%
Male
2
  16.7%
5
  41.7%
7
  29.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Child PTSD Symptom Scale (CPSS)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Plus CBT Placebo Pill
Hide Arm/Group Description:

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.

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 teh 12-session CBT protocol.

Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.4  (9.7) 11.0  (8.9)
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine Plus CBT Placebo Pill
Hide Arm/Group Description

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.

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 teh 12-session CBT protocol.

All-Cause Mortality
D-cycloserine Plus CBT Placebo Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine Plus CBT Placebo Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-cycloserine Plus CBT Placebo Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      2/12 (16.67%)    
Nervous system disorders     
drowsy   1/12 (8.33%)  2 2/12 (16.67%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Michael Scheeringa
Organization: Tulane University
Phone: 5049882167
Responsible Party: Michael S. Scheeringa, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT01157429     History of Changes
Other Study ID Numbers: Tulane-09-00450
First Submitted: July 6, 2010
First Posted: July 7, 2010
Results First Submitted: August 20, 2016
Results First Posted: June 6, 2017
Last Update Posted: June 6, 2017