PTSD Clinical Trial - Effect of D-cycloserine on a Short Imagery

Status Withdrawn

Clinical Trial Summary

This study aims to investigate the utility of d-cycloserine (DCS) for enhancing the effect of a novel psychosocial intervention, imagery rescripting (ImRs), in adults with mild to moderate PTSD symptoms after experiencing a traumatic event such as sexual or physical assault, serious accident, etc. Participants will receive 4 sessions of either cognitive behavioral therapy with imagery rescripting or cognitive behavioral therapy with imaginal exposure and will receive study medication (DCS or Pill placebo) prior to Session 2 and Session 3.

Clinical Trial Description

The primary aim of this proof-of-concept-study is to investigate the utility of d-cycloserine (DCS; a partial N-methyl-D-aspartate receptor agonist) for enhancing the effect of a novel psychosocial intervention, imagery rescripting (ImRs). ImRs is a therapeutic technique that has shown positive outcomes for people suffering from PTSD and as an adjunct to CBT for PTSD. Patients are asked to recall their memory of a specific traumatic experience, and then to imagine an intervention that changes the course and outcome of the event to produce a more satisfying result. It is hypothesized that reconsolidation of the trauma memory is the mechanism of ImRs. DCS augments exposure therapy but also appears to enhance reconsolidation of memory. We hypothesize that DCS will enhance the effect of ImRs by incorporating safety cues into the trauma memory. Sixty adults with PTSD symptoms due to a traumatic event at least three months prior to intake will receive 4 sessions of either: CBT + ImRs, or CBT + imaginal exposure (IE). In sessions 2 and 3, participants will be randomized to receive either DCS or placebo (PLA). We hypothesize that DCS + ImRs sessions will enhance treatment outcome by facilitating reconsolidation of the trauma memories incorporating new safety cues. We also hypothesize that ImRs + PLA will provide equal or better outcomes as the IE + PLA condition. The primary outcome measure will be improvements in PTSD symptoms, as assessed at baseline, post-treatment and at 1-month follow-up. Secondary outcome measures will be self-report questionnaires assessing depression symptoms, general psychological complaints, sleep quality, quality of life, and PTSD cognitions. ;

Study Design

Related Conditions & MeSH terms

PTSD

Clinical Trial Details

NCT number	NCT03216356
Study type	Interventional
Source	Boston University Charles River Campus
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	September 2016
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms