Powerpoint presentation

A Randomized, Placebo-Controlled Trial of the Dopamine-ß-Hydroxylase
(DBH) Inhibitor, Nepicastat, for the Treatment of PTSD in OIF/OEF Veterans
Traci Dutton, PharmD, Lori Davis, MD, Catherine Ball, LCSW,
Allison Kluz, MS, Ann Mahaney-Price, CRNP, Katherine Muhlstadt, PharmD
Tuscaloosa VA Medical Center (TVAMC), Tuscaloosa, AL BACKGROUND
NEPICASTAT: A dopamine-β-hydroxylase inhibitor
OUTCOMES
Dopamine (DA) is converted to norepinephrine Hypothesis to be Tested: Subjects treated with
Current events have lead to an increase in nepicastat will have significantly reduced PTSD Dopamine-ß-hydroxylase inhibitors decrease symptoms than those treated with placebo. survey of US combat infantry units reported the amount of norepinephrine by inhibiting DBH Assessments: Subjects will be assessed at
that approximately 20% of those who served in conversion of dopamine to norepinephrine. baseline, weekly for 6 weeks, and then every 2 Afghanistan reported symptoms consistent with Primary Outcome: Clinician-Administered PTSD
Scale (CAPS) hyperarousal subscale D (CAPS-D) Secondary Outcomes: Clinician-Administered
PTSD is a chronic and costly illness that is associated with significant dysfunction, Montgomery Asberg Depression Rating Scale, premature death, increased risk of suicide, Dose (mg/kg)
Clinical-Global Severity and Improvement, Quality increased substance abuse/dependence, and of Life Enjoyment and Satisfaction Questionnaire, long-term disability, especially if left untreated. Study Design: A phase II, 6-week, prospective,
Davidson Trauma Scale, and the Sheehan Disability Scale Unfortunately, current treatments for PTSD are multi-site, double-blind, placebo-controlled, not very effective and thus, novel treatments randomized clinical trial (RCT) of nepicastat for PTSD are needed. Preclinical and clinical monotherapy for PTSD in 120 subjects who have This study is ongoing. There are no results at research define a substantial increase in previously served in a combat zone during this time. Nepicastat is a novel agent seeking norepinephrine (NE) activity associated with PTSD. Recent clinical studies have shown Enduring Freedom (OIF/OEF). The RCT will be followed by an 8-week open extension phase in Authors of this presentation have the following to disclose concerning possible reducing the NE hyperactivity using agents like which patients who have a defined positive financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation: NE post-synaptic antagonists. Key support for clinical response to the study medication will the proposed study with nepicastat is based on continue on open-lapel nepicastat to evaluate Lori Davis: Consultant–Eli Lilly; Speaker–AstraZeneca; Research – AstraZeneca a similar improvement in PTSD symptoms after Catherine Ball: Nothing to discloseAllison Kluz: Nothing to disclose a study that reported reduced hyperarousal Clinical Sites: Veterans Affairs Medical Centers:
symptoms after treatment with disulfiram, a Tuscaloosa VA; Houston VA;Charleston VA; San CDMRP Grant Number: W81CWH-08-2-0071 and W81XWH-09-1-0287. Study medication provided by Synosia Therapeutics.

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