David J. Katzelnick

Treatment of social phobia with gabapentin: A placebo-controlled study

A randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate the efficacy and safety of gabapentin in relieving the symptoms of social phobia. Sixty-nine patients were randomly assigned to receive double-blind treatment with either gabapentin (dosed flexibly between 900 and 3,600 mg daily in three divided doses) or placebo for 14 weeks. A significant reduction (p < 0.05) in the symptoms of social phobia was observed among patients on gabapentin compared with those on placebo as evaluated by clinician- and patient-rated scales. Results were similar for the intent-to-treat and week-2 completer populations. Adverse events were consistent with the known side effect profile of gabapentin. Dizziness (p = 0.05), dry mouth (p = 0.05), somnolence, nausea, flatulence, and decreased libido occurred at a higher frequency among patients receiving gabapentin than among those receiving placebo. No serious adverse events or deaths were reported. On the basis of these limited data, it seems that gabapentin offers a favorable risk-benefit ratio for the treatment of patients with social phobia. Further studies are required to confirm this effect and to determine whether a dose-response relationship exists.

Behavioral versus pharmacological treatments of obsessive compulsive disorder : a meta-analysis

Abstract The goal of the study was to provide a quantitative analysis of the relative efficacy of all five currently available serotonin reuptake inhibitors (SRIs) and behavior therapy [exposure and response prevention (ERP)] for obsessive compulsive disorder. The relationship between effect size and methodological characteristics was also empirically examined. A search was conducted of several computerized databases covering the dates from 1973 to 1997. Seventy-seven studies were identified, yielding 106 treatment comparisons involving 4641 patients. Effect sizes were analyzed between individual interventions and between intervention class [SRI, ERP or the combined treatment of an SRI with ERP(ERP/SRI)]. Data were analyzed both before and after controlling for methodological variables. The effect size for clomipramine (CMI) was significantly greater than the other SRIs, with the exception of fluoxetine (FLX). CMI was not significantly greater than ERP or ERP/SRI. As a class, ERP was significantly greater than SRIs as a whole. Effect sizes were larger for studies without a control group or random assignment, for self-reported outcome measures, and varied significantly by method of effect size calculation. Year of publication was significantly related to effect size. When controlling for these methodological variables, CMI was not significantly greater than FLX or fluvoxamine (FLV), and ERP was no longer significantly greater than the SRIs as a whole. No significant difference was found between CMI and the other SRIs as a group in head to head trials. No differences in drop-out rates were found. CMI stands out from the other SRIs. This difference is probably not clinically significant enough to warrant first choice treatment, given CMI’s greater lethality in overdose. The choice between an SRI or ERP is dominated primarily by the infrequent availability of ERP and to a lesser degree by personal preference. Methodological differences significantly impact effect size.

Brofaromine for social phobia: a multicenter, placebo-controlled, double-blind study.

The safety and efficacy of brofaromine, a reversible and selective monoamine oxidase inhibitor, were examined in a multicenter trial of 102 outpatients with social phobia. After a 1-week placebo washout, subjects were randomly assigned to 10 weeks of treatment with either brofaromine (N = 52) or placebo (N = 50). Brofaromine dosage began at 50 mg/day and was titrated to a maximum of 150 mg/day, depending on treatment response. Brofaromine produced a significantly greater change from baseline in Liebowitz Social Anxiety Scale (LSAS) scores compared with placebo, F(1) = 6.01, p < 0.016. Mean LSAS scores decreased from 81.8 at baseline to 62.6 at endpoint for brofaromine, t = 5.41,p < 0.001, and from 79.8 to 70.7 for placebo, t = 3.66, p < 0.001. Eleven of the 14 brofaromine early terminators discontinued because of adverse experiences, as did 4 of the 17 placebo early terminators. Side effects more common with brofaromine than placebo included insomnia, dizziness, dry mouth, anorexia, tinnitus, and tremor. No clinically significant variations in vital signs or laboratory values were found. The findings are consistent with the clinical efficacy for the treatment of social phobia.

Computer-administered clinical rating scales A review

Abstract While clinician-administered symptom rating scales are the most commonly used outcome measures in pharmaceutical research, error variance due to poor inter-rater reliability increases the risk of type II errors in multi-center clinical trials. Such error variance could obscure true differences between active drug and placebo, or between two comparator compounds. Computer-administered versions of symptom rating scales originally designed to be administered by trained clinicians offer a solution to this problem. This paper reviews the empirical data on the reliability, validity and equivalence of computer-administered rating scales. Computer-administered versions of clinician-administered scales are now available for the assessment of depression, anxiety, obsessive-compulsive disorder, and social phobia. Validation studies support the reliability, validity and equivalence of these scales. Patient reaction has been positive, with patients generally more honest with and often preferring the computer for assessing sensitive areas such as suicide, alcohol or drug abuse, sexual behavior, or HIV related symptoms. Applications using Interactive Voice Response (IVR) technology facilitate longitudinal monitoring of patients without requiring office visits to collect data, increase the accessibility of information to the clinician, and the quality of patient care through more informed decision making. When used in accordance with established ethical guidelines, computers offer a reliable, inexpensive, accessible, and time-efficient means of assessing psychiatric symptoms.

Systematic Use of Patient-Rated Depression Severity Monitoring: Is It Helpful and Feasible in Clinical Psychiatry?

OBJECTIVE The gap between evidence-based treatments and routine care has been well established. Findings from the Sequenced Treatments Alternatives to Relieve Depression (STAR*D) emphasized the importance of measurement-based care for the treatment of depression as a key ingredient for achieving response and remission; yet measurement-based care approaches are not commonly used in clinical practice. METHODS The Nine-Item Patient Health Questionnaire (PHQ-9) for monitoring depression severity was introduced in 19 diverse psychiatric practices. During the one-year course of the project the helpfulness and feasibility of implementation of PHQ-9 in these psychiatric practices were studied. The project was modeled after the Institute for Healthcare Improvement Breakthrough Series. Two of the 19 practices dropped out during the course of the project. RESULTS By the conclusion of the study, all remaining 17 practices had adopted PHQ-9 as a routine part of depression care in their practice. On the basis of responses from 17 psychiatrists from those practices, PHQ-9 scores influenced clinical decision making for 93% of 6,096 patient contacts. With the additional information gained from the PHQ-9 score, one or more treatment changes occurred during 40% of these clinical contacts. Changing the dosage of antidepressant medication and adding another medication were the most common treatment changes recorded by psychiatrists, followed by starting or increasing psychotherapy and by switching or initiating antidepressants. In 3% of the patient contacts, using the PHQ-9 led to additional suicide risk assessment. CONCLUSIONS The study findings suggest that adopting measurement-based care, such as using the PHQ-9, is achievable, even in practices with limited resources.

Fluoxetine in social phobia: a double-blind, placebo-controlled pilot study.

The objective of the study was to examine the efficacy of fluoxetine in social phobia. Sixty subjects were randomly assigned to 14 weeks of double-blind therapy with either fluoxetine or placebo. Dose was fixed at 20 mg for fluoxetine during the first 8 weeks of double-blind treatment; during the final 6 weeks, the dose could be increased every two weeks by 20 mg to a maximum of 60 mg/day. An intentto-treat analysis was used. A significant change from baseline to endpoint was found for both fluoxetine and placebo on the Liebowitz Social Anxiety Scale. However, no significant difference was found between fluoxetine and placebo. The change for fluoxetine was somewhat lower than that found with other selective serotonin reuptake inhibitors, whereas the placebo response was greater. Fluoxetine failed to separate from placebo in this trial. It is unknown whether a larger dose for longer duration would have yielded separation from placebo. A higher than usual placebo response rate was found.

Computer-administered clinical rating scales

While clinician-administered symptom rating scales are the most commonly used outcome measures in pharmaceutical research, error variance due to poor inter-rater reliability increases the risk of type II errors in multi-center clinical trials. Such error variance could obscure true differences between active drug and placebo, or between two comparator compounds. Computer-administered versions of symptom rating scales originally designed to be administered by trained clinicians offer a solution to this problem. This paper reviews the empirical data on the reliability, validity and equivalence of computer-administered rating scales. Computer-administered versions of clinician-administered scales are now available for the assessment of depression, anxiety, obsessive-compulsive disorder, and social phobia. Validation studies support the reliability, validity and equivalence of these scales. Patient reaction has been positive, with patients generally more honest with and often preferring the computer for assessing sensitive areas such as suicide, alcohol or drug abuse, sexual behavior, or HIV related symptoms. Applications using Interactive Voice Response (IVR) technology facilitate longitudinal monitoring of patients without requiring office visits to collect data, increase the accessibility of information to the clinician, and the quality of patient care through more informed decision making. When used in accordance with established ethical guidelines, computers offer a reliable, inexpensive, accessible, and time-efficient means of assessing psychiatric symptoms.

Implementation of a care management model for depression at two primary care clinics

The Mayo clinic participated in the Depression Improvement Across Minnesota, Offering a New Direction model at two Mayo Family Clinics, that is, the Rochester Northwest and Northeast sites. Although the Northwest and Northeast clinics demonstrated the best 6-month remission rates in the state during the first year of implementation, they were retrospectively found to differ on several process issues and on measures related to the populations served. Six-month remission rates were significantly better at Northwest clinic; yet, Northeast clinic had more patient contacts. Differences in rates of activation into care management, care management accessibility, and differences in maintaining contact with patients at 6 months may explain some of these results.

Integration of mental health resources in a primary care setting leads to increased provider satisfaction and patient access

OBJECTIVE This evaluation assessed the opinions and experiences of primary care providers and their support staff before and after implementation of expanded on-site mental health services and related system changes in a primary care clinic. METHOD Individual semistructured interviews, which contained a combination of open-ended questions and rating scales, were used to elicit opinions about mental health services before on-site system and resource changes occurred and repeated following changes that were intended to improve access to on-site mental health care. RESULTS In the first set of interviews, prior to expanding mental health services, primary care providers and support staff were generally dissatisfied with the availability and scheduling of on-site mental health care. Patients were often referred outside the primary care clinic for mental health treatment, to the detriment of communication and coordinated care. Follow-up interviews conducted after expansion of mental health services, scheduling refinements and other system changes revealed improved provider satisfaction in treatment access and coordination of care. Providers appreciated immediate and on-site social worker availability to triage mental health needs and help access care, and on-site treatment was viewed as important for remaining informed about patient care the primary care providers are not delivering directly. CONCLUSIONS Expanding integrated mental health services resulted in increased staff and provider satisfaction. Our evaluation identified key components of satisfaction, including on-site collaboration and assistance triaging patient needs. The sustainability of integrated models of care requires additional study.

Computer-administered rating scales for social anxiety in a clinical drug trial

Computer‐administered versions of two clinician‐administered symptom rating scales for social anxiety (the Liebowitz Social Anxiety Scale [LSAS] and the Brief Social Phobia Scale [BSPS]) and one paper‐and‐pencil scale (the Fear Questionnaire) were developed and utilized in a clinical trial for social phobia. The reliability and validity of the computer versions were examined, as were their equivalence to the traditional versions. Correlations between the computer and original versions were high at baseline, and remained high throughout the study. The internal consistency reliability of the computer scales was also high, and almost identical to the original versions. Mean score differences between computer and original versions were not significant at baseline, and no significant differences were found between computer and traditional versions on the amount of change detected from baseline to endpoint. Seventy‐seven percent of subjects felt that the computer did not interfere with their visit at baseline and a plurality (36%) preferred the computer, with 30% preferring the clinician and 34% having no preference. By the end of the study, the plurality (41%) had no preference, with 27% preferring the computer and 32% preferring the clinician. Results support the use of these computer‐administered symptom rating scales of social anxiety as a viable alternative to the clinician‐administered versions with this subset of patients, which should offer researchers and clinicians a reliable and cost‐effective method for evaluating social phobia. Depression and Anxiety 7:97–104, 1998.