Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder (DCSPanic)
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|ClinicalTrials.gov Identifier: NCT00790868|
Recruitment Status : Unknown
Verified April 2013 by Michael Otto, Boston University.
Recruitment status was: Active, not recruiting
First Posted : November 14, 2008
Last Update Posted : May 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Panic Disorder||Drug: d-cycloserine Drug: placebo||Phase 2|
In this application, we propose to further validate and expand upon one of the apparent striking successes of translational research. Specifically, basic research on the neural circuitry underlying fear extinction led to the examination of d-cycloserine (DCS), a partial agonist of the NMDA receptor in the amygdala, as an agent capable of enhancing extinction learning (Davis et al., 2006; Davis et al., in press). Following successful validation of this strategy in the animal laboratory (see Ledgerwood et al., 2005; Richardson et al., 2004), Ressler et al. (2004) showed that single doses of d-cycloserine (DCS) could enhance extinction in a human exposure paradigm for height phobic adults. This exciting initial finding was replicated by our research team for the treatment of social anxiety disorder (Hofmann et al., 2006), as well as an initial pilot study by our research team of the treatment of panic disorder (Tolin et al., 2006; see Preliminary Studies). As discussed by Anderson and Insel (2006), these findings have the potential to foster significant advances in the treatment of anxiety disorders. The present study represents the further application of DCS for augmenting the effects of exposure-based cognitive-behavior therapy (CBT), now applied to the treatment of panic disorder with or without agoraphobia.
In the current application, we propose a five-year study to show the acute and longer-term effects of DCS augmentation of exposure-based CBT relative to placebo augmentation. Our study is noteworthy for the use of a brief treatment strategy that has been shown to be successful in previous trials (e.g., Clark et al., 1999; Roy-Byrne et al., 2005) and has served as the basis for the DCS augmentation effect seen in a pilot study for this application (see Preliminary Studies). By demonstrating that DCS can enhance the results of even a brief treatment strategy, we are seeking to validate an approach that fits well with the practice limitations and applications of CBT in effectiveness studies (e.g., Katon et al., 2006; Roy-Byrne et al. 2005). Furthermore, by studying the genetic predictors of the overall response to CBT, and DCS augmentation in particular, we hope to further elucidate the nature of DCS augmentation and the selection of particularly responsive subgroups of patients in need. This agenda is in accords with "the ultimate goal of personalized therapy: identifying individual patterns of pathophysiology that indicate which pharmacological or behavioral treatment will be most useful for any individual patient" (Anderson & Insel, 2006, p. 320).
Our study design calls for a double blind, randomized, controlled, trial conducted at three treatment sites. Patient with panic disorder will randomly receive DCS or placebo 1 hour prior to sessions 3-5 of a 5-session CBT protocol that includes 2 additional booster sessions over the course of follow-up. We will enter a total of 192 patients over 5 years with the identical treatment protocol followed at each of the sites. Sites will nonetheless differ with respect to study management and analysis procedures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2014|
Other Name: DCS
Placebo Comparator: II
- The change in PDSS score from baseline to the relevant assessment points is the continuous primary outcome measure. Remission status will be used as the primary categorical outcome variable. [ Time Frame: mid, post, follow-up ]
- (1) remission status (2) anxiety sensitivity (3) Q-LES-Q, (4) LIFE-RIFT, MADRS, and non-panic anxiety symptom [ Time Frame: same as above ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790868
|United States, Connecticut|
|Institute of Living|
|Hartford, Connecticut, United States, 06106|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Michael W Otto, PhD||Boston University|
|Principal Investigator:||David F Tolin, PhD||Institute of Living|
|Principal Investigator:||Mark H Pollack, MD||Rush University Medical Center|