A randomized controlled pilot trial of vilazodone for adult separation anxiety disorder.

BACKGROUND: Separation anxiety disorder was recently recognized by fifth edition of the Diagnostic and Statistical Manual of Mental Disorders as a diagnosis in adults, but no publications to date have characterized a sample of patients seeking treatment for adult separation anxiety disorder (ASAD) or assessed treatment efficacy. We hypothesized that vilazodone, a selective serotonin reuptake inhibitor (SSRI) and serotonin 1a (5HT1a ) receptor partial agonist, would have efficacy in ASAD, because SSRIs have appeared efficacious in children with mixed diagnoses including separation anxiety disorder and in animal models of separation anxiety. METHODS: In this pilot study, 24 adults (ages 18-60) with a principal diagnosis of ASAD were randomized to 12 weeks of double-blind treatment with vilazodone (n = 13) or placebo (n = 11). Outcome was assessed by an independent evaluator and self-ratings, and analyzed with mixed effect models. RESULTS: This sample was predominantly female (67%), with comorbid psychiatric disorders (58%), and adult onset of separation anxiety disorder (62%). Response rates at week 12 did not differ significantly between groups. Across all time points, the vilazodone group evidenced greater improvement on the Structured Clinical Interview for Separation Anxiety Symptoms (P = .026) and the Quality of Life Enjoyment and Satisfaction Questionnaire (P = .011), and trends toward greater improvement on the Adult Separation Anxiety Questionnaire (P = .054) and the Clinical Global Impression-Change Scale (P = .086), all with large between-group effect sizes. CONCLUSIONS: Findings demonstrate feasibility of a clinical trial in ASAD, and they suggest that vilazodone may have efficacy in the treatment of ASAD and warrants further study.

An Open-Label Pilot Study of Duloxetine in Patients With Irritable Bowel Syndrome and Comorbid Major Depressive Disorder.

Major depressive disorder (MDD) and irritable bowel syndrome (IBS) frequently co-occur, yet treating their comorbid presentation is challenging. Low-dose tricyclic antidepressants are efficacious for IBS, but higher doses to treat depressive symptoms present tolerability problems, whereas selective serotonin reuptake inhibitors are more tolerable but show inconsistent efficacy for IBS. If efficacious, serotonin-norepinephrine reuptake inhibitors like duloxetine would provide a useful alternative. We explored efficacy, tolerability, and time to onset of action of duloxetine in comorbid IBS-MDD in an open-label, 12-week trial. Repeated-measures mixed-effects regression analysis with the intent-to-treat sample assessed rate of change of the clinician-administered Gastrointestinal Symptoms Rating Scale, Montgomery-Åsberg Depression Rating Scale, and other clinician-administered and self-report scales. Seventeen Hispanic adults with current MDD and comorbid IBS meeting Rome III criteria entered the study. Medical and laboratory assessment ruled out alarm symptoms and signs inconsistent with IBS. Duloxetine led to significant improvement in Gastrointestinal Symptoms Rating Scale and Montgomery-Åsberg Depression Rating Scale scores and 71.4% and 64.3% intent-to-treat response rates for IBS and MDD, respectively. Abdominal pain severity decreased by 56%. Contrary to expectation of rapid analgesic effects, based on duloxetine studies for neuropathic pain, both IBS and MDD symptoms improved gradually; differences in slopes of improvement were nonsignificant. Duloxetine was moderately well tolerated at a mean endpoint dose of 60 mg/d. Study limitations include the lack of placebo control, modest sample size, single ethnic group, and high attrition rate. Duloxetine efficacy for comorbid IBS-MDD should be studied under placebo-controlled conditions with larger and more diverse samples.

COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL.

BACKGROUND: Combined treatment with a selective serotonin reuptake inhibitor (SSRI) plus mirtazapine has shown superior efficacy in some studies of depression, but has not been studied in posttraumatic stress disorder (PTSD). This study aimed to assess acceptability of combined sertraline plus mirtazapine treatment for PTSD and to estimate its effect size relative to sertraline plus placebo. METHODS: Thirty-six adults with PTSD were randomized to 24 weeks of double-blind treatment with sertraline plus mirtazapine or sertraline plus placebo. Outcomes were analyzed with mixed effects models. RESULTS: The combined treatment group showed a significantly greater remission rate (P = .042) and improvement in depressive symptoms (P = .023) than the sertraline plus placebo group. There were no significant group differences in the two primary outcomes of treatment retention and PTSD severity, or in other secondary outcomes (sleep impairment, sexual functioning, quality of life, and physical and mental functioning), but the combined treatment group showed numerical advantages on all of these outcomes, and effect sizes relative to sertraline plus placebo ranged from small to moderate (d = .26-.63). Both treatments were well-tolerated, with significantly increased appetite but not weight gain in the combined treatment group. CONCLUSION: Findings suggest that combined treatment of PTSD with sertraline plus mirtazapine may have clinically meaningful advantages in symptomatic improvement, relative to SSRI treatment alone, and acceptable tolerability. Combined treatment with an SSRI plus mirtazapine in PTSD deserves additional study as initial treatment or as an augmentation strategy for nonresponders to an SSRI.

Immigration and Race: A Challenge of Many Shades.

This article describes the history of race relations and the rapidly changing racial topography of the United States. The authors address the history of racism and discrimination experienced by minority populations and immigrants of color and the psychological effects on these populations and describe the risk factors and protective factors that come into play when individuals are faced with experiences of discrimination and racism. They describe the process of ethnic-racial identity development and the different styles of ethnic-racial socialization and cultural orientation. Ultimately, it explains the importance of ethnicity and race in the psychotherapeutic encounter.

Treatment dropout among veterans and their families: Quantitative and qualitative findings.

BACKGROUND: Psychotherapy noncompletion rates for veterans and their families are high. This study sought to (a) measure noncompletion rates of such patients at a university-based treatment center, (b) compare veteran and family member attrition rates, (c) identify dropout predictors, and (d) explore clinicians' perspectives on treatment noncompletion. METHOD: Using quantitative and qualitative approaches, we analyzed demographic and clinical characteristics of 141 patients (90 military veterans; 51 family members) in a university treatment center. We defined dropout as not completing the time-limited therapy contract. Reviewing semistructured interview data assessing clinicians' perspectives on their patients' dropout, three independent raters agreed on key themes, with interrater coefficient kappa range .74 to 1. RESULTS: Patient attrition was 24%, not differing significantly between veterans and family members. Diagnosis of major depression (MDD) and exposure-based therapies predicted noncompletion, as did higher baseline Hamilton Depression Rating Scale (HDRS) total scores, severe depression (HDRS > 20), lack of Beck Depression Inventory weekly improvement, and history of military sexual trauma. Clinicians mostly attributed noncompletion to patient difficulties coping with intense emotions, especially in exposure-based therapies. CONCLUSION: Noncompletion rate at this study appeared relatively low compared to other veteran-based treatment centers, if still unfortunately substantial. Patients with comorbid MDD/PTSD and exposure-based therapies carried greater noncompletion risk due to the MDD component, and this should be considered in treatment planning. Ongoing discussion of dissatisfaction and patient discontinuation, in the context of a strong therapeutic alliance, might reduce noncompletion in this at-risk population. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Interpersonal Psychotherapy of Posttraumatic Stress Disorder for Veterans and Family Members: An Open Trial.

OBJECTIVE: Military service members and veterans have high rates of posttraumatic stress disorder (PTSD), as do military family members. Exposure-based, cognitive-behavioral approaches have received ample research, but other PTSD therapies require further empirical attention. Interpersonal psychotherapy (IPT) targets affective awareness, life circumstances, and social support. IPT has shown efficacy for civilians with PTSD but awaits rigorous testing among military personnel; only two small military pilot studies and two case reports have been published. Military family members have received minimal attention from clinical outcomes research. Addressing these gaps, this open trial examined IPT for PTSD among veterans, service members, and family members, including a patient subset with comorbid PTSD and depression. METHODS: Fifty U.S. military service members, veterans, and family members (age ≥18 years) were offered 14 sessions of IPT for PTSD. Individuals with psychosis, bipolar disorder, moderate or severe substance use disorders, or high suicide risk were excluded. PTSD and depressive symptoms were assessed at baseline, midtreatment, posttreatment, and 3-month follow-up. RESULTS: Clinician-assessed PTSD (Clinician-Administered PTSD Scale) and depression (Hamilton Depression Rating Scale) symptoms decreased over time in the full sample and the comorbid PTSD/depression subset (p<0.05). Service members, veterans, and family members had similar treatment responses. CONCLUSIONS: Patients receiving IPT showed reductions in PTSD and depressive symptoms. These open trial findings provide preliminary support for the utility of IPT in reducing PTSD symptoms among veterans and family members. This largest IPT trial to date for PTSD in military patients also bolsters the literature on treating military family members.

Maximizing remission from cognitive-behavioral therapy in medicated adults with obsessive-compulsive disorder.

Practice guidelines for adults with obsessive-compulsive disorder (OCD) recommend augmenting serotonin reuptake inhibitors (SRIs) with exposure and ritual prevention (EX/RP). However, fewer than half of patients remit after a standard 17-session EX/RP course. We studied whether extending the course increased overall remission rates and which patient factors predicted remission. Participants were 137 adults with clinically significant OCD (Yale-Brown Obsessive Compulsive Scale [Y-BOCS] score ≥18) despite an adequate SRI trial (≥12 weeks). Continuing their SRI, patients received 17 sessions of twice-weekly EX/RP (standard course). Patients who did not remit (Y-BOCS ≤12) received up to 8 additional sessions (extended course). Of 137 entrants, 123 completed treatment: 49 (35.8%) remitted with the standard course and another 46 (33.6%) with the extended course. Poorer patient homework adherence, more Obsessive-Compulsive Personality Disorder (OCPD) traits, and the Brain-Derived Neurotrophic Factor (BDNF) Val66MET genotype were associated with lower odds of standard course remission. Only homework adherence differentiated non-remitters from extended course remitters. Extending the EX/RP course from 17 to 25 sessions enabled many (69.3%) OCD patients on SRIs to achieve remission. Although behavioral (patient homework adherence), psychological (OCPD traits), and biological (BDNF genotype) factors influenced odds of EX/RP remission, homework adherence was the most potent patient factor overall.

A double-masked, placebo-controlled study of fluoxetine for hypochondriasis.

This study assessed the efficacy, durability, and tolerability of fluoxetine for hypochondriasis, a disorder for which controlled pharmacological trials are scarce. Fifty-seven patients with hypochondriasis were enrolled: 12 discontinued during the placebo run-in, and 45 were randomized to either fluoxetine or placebo for 12 weeks (acute treatment). Responder status was defined as a Clinical Global Impression rating for hypochondriasis of much or very much improved. Secondary outcome measures included severity of hypochondriasis, somatization, anxiety, and depression. Responders to acute treatment entered a 12-week maintenance phase to week 24. Sustained responders at week 24 entered a 12-week double-masked discontinuation phase. Primary analysis used the intent-to-treat sample. More patients responded with improvement in hypochondriasis when given fluoxetine compared with placebo, starting at week 8 (50.0% vs 19.0%, P = 0.03) and continuing to week 12 (62.5% vs 33.3%, P = 0.05). Mean dose at week 12 dose was 51.4 mg (SD, +/-23 mg). The acute treatment response was maintained to week 24 with more responders in the fluoxetine compared with the placebo group (54.2% vs 23.8%, P = 0.04). Significant improvement was not noted on the continuous secondary outcomes measures of hypochondriasis, with the exception of the Clinical Global Impression hypochondriasis severity scale at week 24. Likelihood of response was not associated with severity of psychiatric comorbidity. Durability of response after controlled drug discontinuation could not be reasonably assessed, given the small sample size of patients who entered the discontinuation phase (n = 10). Fluoxetine was well tolerated, with no significant differences in discontinuation due to side effects between treatment groups. Fluoxetine is a moderately effective and well-tolerated treatment for hypochondriasis.

A controlled trial of paroxetine for chronic PTSD, dissociation, and interpersonal problems in mostly minority adults.

This study evaluated the efficacy of paroxetine for symptoms and associated features of chronic posttraumatic stress disorder (PTSD), interpersonal problems, and dissociative symptoms in an urban population of mostly minority adults. Adult outpatients with a primary DSM-IV diagnosis of chronic PTSD received 1 week of single-blind placebo (N = 70). Those not rated as significantly improved were then randomly assigned to placebo (N = 27) or paroxetine (N = 25) for 10 weeks, with a flexible dosage design (maximum 60 mg by week 7). Significantly more patients treated with paroxetine were rated as responders (14/21, 66.7%) on the Clinical Global Impression-Improvement Scale (CGI-I) compared to patients treated with placebo (6/22, 27.3%). Mixed effects models showed greater reductions on the Clinician-Administered PTSD Scale (CAPS) total score (primary plus associated features of PTSD) in the paroxetine versus placebo groups. Paroxetine was also superior to placebo on reduction of dissociative symptoms [Dissociative Experiences Scale (DES) score] and reduction in self-reported interpersonal problems [Inventory of Interpersonal Problems (IIP) score]. In a 12-week maintenance phase, paroxetine response continued to improve, but placebo response did not. Paroxetine was well tolerated and superior to placebo in ameliorating the symptoms of chronic PTSD, associated features of PTSD, dissociative symptoms, and interpersonal problems in the first trial conducted primarily in minority adults.

An open trial of fluvoxamine for hypochondriasis.

The authors conducted a 12-week, open-label trial of fluvoxamine among 18 patients with DSM-IV hypochondriasis. Response was defined as a physician-rated CGI improvement rating of at least "much improved." Four patients discontinued during the 2-week placebo run-in phase. Among 14 patients given fluvoxamine, the response rate was 72.7% (N=8 of 11) for those completing at least 6 weeks of the trial (minimum-treatment analysis) and 57.1% (N=8 of 14) for the intent-to-treat analysis; these are comparable to rates reported previously for fluoxetine. Significant improvement was also noted on each of the self-report and physician-administered hypochondriasis measures. Fluvoxamine was also well tolerated. A controlled trial is needed.

Pharmacological treatment of social anxiety disorder: a meta-analysis.

Placebo-controlled trials have evaluated the efficacy of several medications in the treatment of social anxiety disorder but information regarding their relative efficacy is lacking. We compared the efficacy of medications systematically studied for the treatment of social anxiety disorder using meta-analytic techniques. The methodology included a database search of articles published between January 1980 and June 2001 and manual searches of bibliographies in published manuscripts. Trials were included if they reported outcome data on the Liebowitz Social Anxiety Scale (LSAS) or a categorical measure of responder status. Data were extracted independently by two authors. The Q statistic was used to assess homogeneity across trials. All analyses were conducted using intent-to-treat data. There was substantial heterogeneity across trials. The medications with largest effect sizes were phenelzine [effect size, 1.02; 95% Confidence Interval (CI), 0.52-1.52], clonazepam (effect size, 0.97; 95% CI, 0.49-1.45), gabapentin (effect size, 0.78; 95% CI, 0.29-1.27), brofaromine (effect size, 0.66; 95% CI, 0.38-0.94), and the selective serotonin reuptake inhibitors (SSRIs; effect size, 0.65; 95% CI, 0.50-0.81). There were no statistically significant differences between medications or medication groups. However, formal methods of interim monitoring adapted for meta-analyses suggested strongest evidence of efficacy for SSRIs and brofaromine. Several medications are efficacious for the treatment of social anxiety disorder. The stability of the SSRI effect size estimate in conjunction with other evidence for safety and tolerability and their ability to treat comorbid conditions supports the use of SSRIs as the first-line treatment. Direct comparisons of SSRIs vs. other promising medications deserve consideration.

El impacto psicológico de los ataques terroristas del 11 de septiembre de 2001 en la ciudad de Nueva York: el trastorno por estrés postraumático y la recuperación de una ciudad traumatizada / Psychological impact of terrorist attacks on september 11, 2001 in New York City: posttraumatic stress disorder and the recuperation of a traumatized city

The terrorist attacks on the World Trade Center (WTC) on September 11, 2001 strained the emotional resources of many New York City residents. The expectation of another terrorist attack, including the fear of bio-terrorism, complicates the recovery process of individuals who were directly affected by the disaster. These individuals are experiencing an amalgan of psychological problems, including Posttraumatic Stress Disorder (PTSD), depression, anxiety, traumatic grief, and self-destructive behaviors. In addition, for some victims, the collapse of the WTC was experienced within a religious context of an apocalyptic nature (e.g., "doomsday" or "the end of the world"). To date, this has been the deadliest act of terrorism in the United States. In this paper we discuss the following: (1) the immediate mental health effects of the terrorist attacks, (2) the prevalence of PTSD before and after September 11, 2001, (3) vulnerability factors implicated in the development of PTSD, (4) the immediate responses to the disaster by government, private, and academic institutions, and (5) a brief description of evidence-based treatments for PTSD. The paper concludes with an account of the horrific and terrifying experience of a WTC survivor.

Los ataques terroristas a las Torres Gemelas el 11 de septiembre de 2001 abrumaron los mecanismos psicológicos que utilizan diariamente los neoyorquinos para enfrentar el estrés. La expectativa de otro ataque terrorista, incluyendo el temor al bioterrorismo, complica el proceso de recuperación de muchos individuos afectados directamente por el desastre. Estas personas experimentan una combinación de problemas psicológicos, incluyendo el Trastorno por Estrés Postraumático (TEPT), la depresión, la ansiedad, el duelo traumático, y las conductas auto-destructivas. Además, algunas víctimas vivieron el desplome de las Torres Gemelas dentro de un marco religioso de naturaleza apocalíptica (por ejemplo, "el dia del juicio final" o "el fin del mundo"). Hasta la fecha, éste ha sido el acto terrorista más mortífero en la historia de Estados Unidos. En este artículo discutimos los siguientes temas: (1) el efecto psicólogico inmediato de los ataques terroristas, (2) la prevalencia del TEPT antes de y después del 11 de septiembre de 2001, (3) los factores que aumentan la vulnerabilidad para presentar el TEPT, (4) las respuestas inmediatas al desastre de parte de las instituciones gubernamentales, privadas y académicas, y (5) una descripción breve de los tratamientos para el TEPT avalados por la evidencia científica. El artículo concluye con un relato de la horrible y aterradora experiencia de un sobreviviente de los ataques.