Post-Traumatic Stress Disorder Clinical Trial
Official title:
Comparative Study of the Efficacy of a Cognitive-Behavioral Therapy for Post-Traumatic Stress Disorder With or Without D-Cycloserine
The purpose of this study is to investigate if the effectiveness of cognitive-behavioral therapy for post-traumatic stress disorder can be increased by combining it with D-cycloserine (TCC/D-cycloserine) by comparing with a placebo (TCC/placebo).
Post-traumatic stress disorder (PTSD) is one of the most frequent anxiety disorder in the
general population (Kessler and al., 2005). Currently, the treatment of choice for PTSD is
cognitive-behavioral therapy (CBT; Foa, Davidson and Frances, 1999). Based on remission
rates after treatment, successful outcomes of CBT for PTSD vary between 46 and 54 % when
dropouts are considered, and between 56 and 70% among those who completed their therapy
(Bradley and al., 2005). Thus, there is room for improvement.
Recently, the results of two published studies on the treatment of phobia of heights
(Ressler and al., 2004) and social phobia (Hofman, 2006) indicated that the efficacy of CBT
was increased by adding D-cycloserine. The superior efficacy of CBT/D-cycloserine over
CBT/Placebo in the treatment of anxiety disorders can result from a greater release of
glutamate, a substance facilitating the extinction of fear (Davis, Myers, Ressler and
Rothbaum, 2005; Richardson, Ledgerwood an Cranney, 2004). However, to our knowledge, no
study has yet compared CBT/D-cycloserine to CBT/Placebo in the treatment of PTSD. The main
hypothesis of the current study is that the efficacy of CBT for PTSD will be increased when
combined with D-cycloserine compared to a placebo.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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