A proof-of-concept randomized crossover clinical trial of a first-in-class vasopressin 1a receptor antagonist for PTSD: Design, methods, and recruitment.

Background: Almost eight million Americans suffer from Posttraumatic Stress Disorder (PTSD). Current PTSD drug therapies rely on repurposed antidepressants and anxiolytics, which produce undesirable side effects and have recognized compliance issues. Vasopressin represents a promising and novel target for pharmacological intervention. Logistical issues implementing a clinical trial for a novel PTSD pharmaceutical are relatively uncharted territory as trials concerning a new agent have not been published in the past several decades. All published trials have repurposed FDA-approved psychoactive medications with known risk profiles. Our recruitment challenges are discussed in this context. Methods: An 18-week proof-of-concept randomized crossover clinical trial of a first-in-class vasopressin 1a receptor antagonist (SRX246) for PTSD was conducted. All participants received SRX246 for 8 weeks, the placebo for 8 weeks, and the drug vs. placebo arms were compared. Participants were assessed every 2 weeks for PTSD symptoms as well as other medication effects. Results were expected to provide an initial demonstration of safety and tolerability in this clinical population and potentially clinical efficacy in SRX246-treated patients measured by Clinician Administered PTSD Scale (CAPS) score changes, clinical impression, and other indices compared to placebo. The primary hypothesis was that SRX246 would result in a clinically meaningful 10-point reduction in mean CAPS score compared to placebo. Discussion: This study is the first to investigate an oral vasopressin 1a receptor antagonist for PTSD. As a wave of PTSD clinical trials with new pharmaceutical compounds are beginning now, lessons learned from our recruitment challenges may be invaluable to these endeavors.

Is Pet Ownership Helpful in Reducing the Risk and Severity of Geriatric Depression?

Many community-dwelling older adults are searching for ways to remain mentally and physically healthy as they age. One frequently offered suggestion is for older people to adopt a pet to avoid loneliness, to stay socially engaged, and to stave off depression. Despite the ubiquity of this advice in popular culture, research findings are equivocal on whether pet ownership is beneficial to the physical and psychological health of older adults. This article evaluates published data relating to pet ownership and its possible impact on depression and related symptoms in the elderly.

Hypersexual behavior in hasidic jewish inpatients.

Although no published studies explore rates of sexual symptoms among mentally ill Hasidic Jews, anecdotal observations led to the lead author's hypothesis that male Hasidic Jewish psychiatric inpatients often demonstrated hypersexual behavior. We examined whether male Hasidic Jewish psychiatric inpatients had higher reported rates of hypersexual behavior than controls. We reviewed charts of all Hasidic Jews admitted in 1998 to one inpatient psychiatric hospital and age/diagnosis/gender-matched comparisons for evidence of reported hypersexual behavior. Sixty-nine percent of male Hasidic patients and 40% of female Hasidic patients had staff reports of hypersexual behavior compared with 19% of male and 20% of female comparisons. There was statistically significant discordance between male (p <.04) but not female pairs. Increased rates of reported hypersexual behavior in Hasidic male inpatients suggest a link between culture and symptom presentation, which further studies of this unique population group should explore.