NCT00371176

Brief Summary

The primary aim of this project is to examine whether administration of D-Cycloserine (DCS), a partial N-methyl-D-aspartate (NMDA) receptor agonist that has been shown to facilitate fear extinction, enhances the therapeutic benefit of exposure-based cognitive behavioral therapy (CBT) in OEF/OIF veterans with PTSD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 4, 2014

Completed
Last Updated

February 4, 2014

Status Verified

December 1, 2013

Enrollment Period

4.9 years

First QC Date

August 31, 2006

Results QC Date

August 30, 2013

Last Update Submit

December 16, 2013

Conditions

Combat DisordersStress Disorders, Post-Traumatic

Keywords

Cognitive Behavior TherapyCognitive enhancersCombat DisordersD-CycloserineStress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (4)

  • Clinician Administered PTSD Scale-IV

    A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.

    Pre Intervention

  • Clinician Administered PTSD Scale-IV

    A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.

    Post Intervention

  • Clinician Administered PTSD Scale-IV

    A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.

    3 month follow-up

  • Clinician Administered PTSD Scale-IV

    A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.

    6 month follow-up

Secondary Outcomes (8)

  • PTSD Checklist

    Pre Intervention

  • PTSD Checklist

    Post intervention

  • PTSD Checklist

    3 month follow-up

  • PTSD Checklist

    6 month follow-up

  • Beck Depression Inventory

    Pre intervention

  • +3 more secondary outcomes

Study Arms (2)

D-Cycloserine

EXPERIMENTAL

Brief imaginal exposure therapy plus DCS pill

Behavioral: Exposure therapyDrug: D-Cycloserine

Placebo

PLACEBO COMPARATOR

Brief imaginal exposure therapy plus Placebo pill

Behavioral: Exposure therapyOther: Placebo pill

Interventions

Exposure therapyBEHAVIORAL

A manualized form of treatment that involves vividly visualizing indexed trauma with the guidance of a therapist

D-CycloserinePlacebo
D-CycloserineDRUG

A partial NMDA agonist that has been shown in human trials to facilitate and strengthen extinction with CBT.

D-Cycloserine
Placebo pillOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female outpatients 18 years of age or older who served in Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF) and who have a primary diagnosis (designated by the patient as the most important source of distress of PTSD.
  • Willingness and ability to comply with the requirements of the study protocol.

You may not qualify if:

  • A lifetime history of:
  • bipolar disorder
  • schizophrenia
  • psychosis
  • delusional disorders or obsessive-compulsive disorder
  • organic brain syndrome
  • cognitive dysfunction that could interfere with capacity to engage in therapy
  • a history of substance or alcohol dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
  • Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate services.
  • Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.
  • Serious medical illness or instability for which hospitalization may be likely within the next year.
  • Patients with a current or past history of seizures
  • Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., intra uterine device, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
  • Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration specifically targeting PTSD is excluded. General supportive therapy initiated \> 3 months prior is acceptable.
  • Patients with seizures or ongoing severe cognitive impairment that compromised mental status.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Health Care System

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • Litz BT, Salters-Pedneault K, Steenkamp MM, Hermos JA, Bryant RA, Otto MW, Hofmann SG. A randomized placebo-controlled trial of D-cycloserine and exposure therapy for posttraumatic stress disorder. J Psychiatr Res. 2012 Sep;46(9):1184-90. doi: 10.1016/j.jpsychires.2012.05.006. Epub 2012 Jun 12.

    PMID: 22694905RESULT

MeSH Terms

Conditions

Combat DisordersStress Disorders, Post-Traumatic

Interventions

Implosive TherapyCycloserine

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Limitations and Caveats

The study experienced sustained recruitment difficulties, ultimately recruiting a smaller number of participants (N=26) than originally projected (N=68).

Results Point of Contact

Title
Dr. Brett Litz
Organization
Boston VA Healthcare System
brett.litz@va.gov
857 364 4131

Study Officials

  • Brett T. Litz, PhD

    VA Boston Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2011

Study Completion

July 1, 2012

Last Updated

February 4, 2014

Results First Posted

February 4, 2014

Record last verified: 2013-12

Locations

US(1)