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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Tulane University School of Medicine.
Recruitment status was  Active, not recruiting
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: June 29, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT alone 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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Tulane University School of Medicine:

Primary Outcome Measures:
  • Number of PTSD symptoms [ Time Frame: After 12 therapy sessions. ] [ Designated as safety issue: No ]
    Symptoms will be determined by a diagnostic interview.


Secondary Outcome Measures:
  • Number of anxiety symptoms [ Time Frame: After 12 therapy sessions. ] [ Designated as safety issue: No ]
    Symptoms determined by self-report and parent-report checklists.


Estimated Enrollment: 56
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated 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
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.

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
Genders Eligible for Study:   Both
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

No publications provided

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
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Tulane University School of Medicine:
Cognitive Behavior Therapy
Children
Adolescents
Pharmacotherapy

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antibiotics, Antitubercular
Antimetabolites
Antitubercular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014