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

• Sponsor: Tulane University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01157429
• Collaborator: National Alliance for Research on Schizophrenia and Depression (Other)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1

Study Details

Study Description

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 13-18 year-old children.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder; PTSD	Drug: D-cycloserine; Drug: Placebo pill; Behavioral: CBT	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: D-cycloserine Adjunctive Treatment for PTSD in Adolescents
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

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.	Drug: D-cycloserine; D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.; Other Names: Seromycin ; Behavioral: CBT; 12-session CBT protocol, called Youth PTSD Treatment.; Other Names: cognitive behavioral therapy
Placebo Comparator: Placebo pill Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.	Drug: Placebo pill; Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol.; Behavioral: CBT; 12-session CBT protocol, called Youth PTSD Treatment.; Other Names: cognitive behavioral therapy

Outcome Measures

Primary Outcome Measures

1. Child PTSD Symptom Scale (CPSS) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tulane University Health Sciences Center, 1440 Canal St.	New Orleans	Louisiana	United States	70112

Sponsors and Collaborators

• Tulane University School of Medicine
• National Alliance for Research on Schizophrenia and Depression

Investigators

• Principal Investigator: Michael S Scheeringa, MD, MPH, Tulane University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael S. Scheeringa, Professor, Tulane University School of Medicine
• ClinicalTrials.gov Identifier: NCT01157429
• Other Study ID Numbers: Tulane-09-00450
• First Posted: Jul 7, 2010
• Last Update Posted: Jun 6, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Michael S. Scheeringa, Professor, Tulane University School of Medicine: Cognitive Behavior Therapy; Children; Adolescents; Pharmacotherapy
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Cycloserine

Study Results

Participant Flow

Pre-assignment Detail	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
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.
Period Title: Overall Study
STARTED	12	12
COMPLETED	8	8
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	D-cycloserine Plus CBT	Placebo Pill	Total
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 Participants	12	12	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.7 (1.6)	15.9 (1.7)	15.8 (1.6)
Sex: Female, Male (Count of Participants)
Female	10 83.3%	7 58.3%	17 70.8%
Male	2 16.7%	5 41.7%	7 29.2%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Child PTSD Symptom Scale (CPSS)
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-cycloserine Plus CBT	Placebo Pill
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.
Measure Participants	8	8
Mean (Standard Deviation) [units on a scale]	20.4 (9.7)	11.0 (8.9)

Adverse Events

Time Frame	2 months
Arm/Group Title	D-cycloserine Plus CBT		Placebo Pill
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	D-cycloserine Plus CBT		Placebo Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	D-cycloserine Plus CBT		Placebo Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		2/12 (16.7%)
Nervous system disorders
drowsy	1/12 (8.3%)	2	2/12 (16.7%)	2

Limitations/Caveats

[Not Specified]

More Information

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.