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

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Michael S. Scheeringa, Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT01157429
First received: July 6, 2010
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Posttraumatic Stress Disorder PTSD Drug: D-cycloserine Drug: Placebo pill Behavioral: CBT Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: D-cycloserine Adjunctive Treatment for PTSD in Adolescents

Resource links provided by NLM:


Further study details as provided by Michael S. Scheeringa, Tulane University School of Medicine:

Primary Outcome Measures:
  • 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).


Enrollment: 24
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Seromycin
Behavioral: CBT
12-session CBT protocol, called Youth PTSD Treatment.
Other Name: 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 Name: cognitive behavioral therapy

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.
  Eligibility

Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157429

Locations
United States, Louisiana
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael S. Scheeringa, Professor, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT01157429     History of Changes
Other Study ID Numbers: Tulane-09-00450
Study First Received: July 6, 2010
Results First Received: August 20, 2016
Last Updated: April 25, 2017

Keywords provided by Michael S. Scheeringa, Tulane University School of Medicine:
Cognitive Behavior Therapy
Children
Adolescents
Pharmacotherapy

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017