Improvements in Compassion and Fears of Compassion throughout the COVID-19 Pandemic: A Multinational Study.

During large-scale disasters, social support, caring behaviours, and compassion are shown to protect against poor mental health outcomes. This multi-national study aimed to assess the fluctuations in compassion over time during the COVID-19 pandemic. Respondents (Time 1 n = 4156, Time 2 n = 980, Time 3 n = 825) from 23 countries completed online self-report questionnaires measuring the flows of compassion (i.e., Compassionate Engagement and Action Scales) and fears of compassion toward self and others and from others (i.e., Fears of Compassion Scales) and mental health at three time-points during a 10-month period. The results for the flows of compassion showed that self-compassion increased at Time 3. Compassion for others increased at Time 2 and 3 for the general population, but in contrast, it decreased in health professionals, possibly linked to burnout. Compassion from others did not change in Time 2, but it did increase significantly in Time 3. For fears of compassion, fears of self-compassion reduced over time, fears of compassion for others showed more variation, reducing for the general public but increasing for health professionals, whilst fears of compassion from others did not change over time. Health professionals, those with compassion training, older adults, and women showed greater flows of compassion and lower fears of compassion compared with the general population, those without compassion training, younger adults, and men. These findings highlight that, in a period of shared suffering, people from multiple countries and nationalities show a cumulative improvement in compassion and reduction in fears of compassion, suggesting that, when there is intense suffering, people become more compassionate to self and others and less afraid of, and resistant to, compassion.

Compassion Protects Mental Health and Social Safeness During the COVID-19 Pandemic Across 21 Countries.

Objectives: The COVID-19 pandemic is having an unprecedented detrimental impact on mental health in people around the world. It is important therefore to explore factors that may buffer or accentuate the risk of mental health problems in this context. Given that compassion has numerous benefits for mental health, emotion regulation, and social relationships, this study examines the buffering effects of different flows of compassion (for self, for others, from others) against the impact of perceived threat of COVID-19 on depression, anxiety, and stress, and social safeness. Methods: The study was conducted in a sample of 4057 adult participants from the general community population, collected across 21 countries from Europe, Middle East, North America, South America, Asia, and Oceania. Participants completed self-report measures of perceived threat of COVID-19, compassion (for self, for others, from others), depression, anxiety, stress, and social safeness. Results: Perceived threat of COVID-19 was associated with higher scores in depression, anxiety, and stress, and lower scores in social safeness. Self-compassion and compassion from others were associated with lower psychological distress and higher social safeness. Compassion for others was associated with lower depressive symptoms. Self-compassion moderated the relationship between perceived threat of COVID-19 on depression, anxiety, and stress, whereas compassion from others moderated the effects of fears of contracting COVID-19 on social safeness. These effects were consistent across all countries. Conclusions: Our findings highlight the universal protective role of compassion, in particular self-compassion and compassion from others, in promoting resilience by buffering against the harmful effects of the COVID-19 pandemic on mental health and social safeness. Supplementary Information: The online version contains supplementary material available at 10.1007/s12671-021-01822-2.

The role of social connection on the experience of COVID-19 related post-traumatic growth and stress.

BACKGROUND: Historically social connection has been an important way through which humans have coped with large-scale threatening events. In the context of the COVID-19 pandemic, lockdowns have deprived people of major sources of social support and coping, with others representing threats. Hence, a major stressor during the pandemic has been a sense of social disconnection and loneliness. This study explores how people's experience of compassion and feeling socially safe and connected, in contrast to feeling socially disconnected, lonely and fearful of compassion, effects the impact of perceived threat of COVID-19 on post-traumatic growth and post-traumatic stress. METHODS: Adult participants from the general population (N = 4057) across 21 countries worldwide, completed self-report measures of social connection (compassion for self, from others, for others; social safeness), social disconnection (fears of compassion for self, from others, for others; loneliness), perceived threat of COVID-19, post-traumatic growth and traumatic stress. RESULTS: Perceived threat of COVID-19 predicted increased post-traumatic growth and traumatic stress. Social connection (compassion and social safeness) predicted higher post-traumatic growth and traumatic stress, whereas social disconnection (fears of compassion and loneliness) predicted increased traumatic symptoms only. Social connection heightened the impact of perceived threat of COVID-19 on post-traumatic growth, while social disconnection weakened this impact. Social disconnection magnified the impact of the perceived threat of COVID-19 on traumatic stress. These effects were consistent across all countries. CONCLUSIONS: Social connection is key to how people adapt and cope with the worldwide COVID-19 crisis and may facilitate post-traumatic growth in the context of the threat experienced during the pandemic. In contrast, social disconnection increases vulnerability to develop post-traumatic stress in this threatening context. Public health and Government organizations could implement interventions to foster compassion and feelings of social safeness and reduce experiences of social disconnection, thus promoting growth, resilience and mental wellbeing during and following the pandemic.

Fears of compassion magnify the harmful effects of threat of COVID-19 on mental health and social safeness across 21 countries.

BACKGROUND: The COVID-19 pandemic is a massive global health crisis with damaging consequences to mental health and social relationships. Exploring factors that may heighten or buffer the risk of mental health problems in this context is thus critical. Whilst compassion may be a protective factor, in contrast fears of compassion increase vulnerability to psychosocial distress and may amplify the impact of the pandemic on mental health. This study explores the magnifying effects of fears of compassion on the impact of perceived threat of COVID-19 on depression, anxiety and stress, and social safeness. METHODS: Adult participants from the general population (N = 4057) were recruited across 21 countries worldwide, and completed self-report measures of perceived threat of COVID-19, fears of compassion (for self, from others, for others), depression, anxiety, stress and social safeness. RESULTS: Perceived threat of COVID-19 predicted increased depression, anxiety and stress. The three flows of fears of compassion predicted higher levels of depression, anxiety and stress and lower social safeness. All fears of compassion moderated (heightened) the impact of perceived threat of COVID-19 on psychological distress. Only fears of compassion from others moderated the effects of likelihood of contracting COVID-19 on social safeness. These effects were consistent across all countries. CONCLUSIONS: Fears of compassion have a universal magnifying effect on the damaging impact of the COVID-19 pandemic on mental health and social safeness. Compassion focused interventions and communications could be implemented to reduce resistances to compassion and promote mental wellbeing during and following the pandemic.

Developing a Compassionate Internal Supervisor: Compassion-Focused Therapy for Trainee Therapists.

The concept of an 'internal supervisor' has been used in psychotherapy to describe the way in which the supervisory relationship is internalized and utilized by the supervisee. This research explores the possibility, and potential benefit, of training therapists to develop a 'compassionate internal supervisor'. A training programme was developed for trainee cognitive-behavioural therapists using adapted versions of compassion-focused therapy interventions. The training focused on guided imagery exercises and reflective practices undertaken for a 4-week period. Seven trainee cognitive-behavioural therapists were interviewed, utilizing a semi-structured format, regarding their experience of the training programme. The resulting transcriptions were analysed using Interpretative Phenomenological Analysis (IPA). The analysis identified six super-ordinate themes: (1) the varied nature of the supervisor image, (2) blocks and their overcoming, (3) increased compassion and regulation of emotion, (4) impact on cognitive processes, (5) internalization and integration, and (6) professional and personal benefit. The themes describe the varied ways in which participants created and experienced their compassionate supervisor imagery. Working with the personal blocks encountered in the process provided participants with a deeper understanding of the nature of compassion and its potential to support them in their training, practice and personal lives. The process and impact of 'internalizing' a compassionate supervisory relationship is described by participants and then discussed for potential implications for psychotherapy training and self-practice. Copyright © 2016 John Wiley & Sons, Ltd. KEY PRACTITIONER MESSAGE: Compassion-focused therapy, and related compassionate-mind imagery exercises, can be adapted specifically to develop compassion in trainee psychotherapists. Creating, and engaging with, an 'ideal compassionate supervisor' in an imaginal form can support psychotherapy trainees in their clinical practice and development, their supervision and their personal lives. The cultivation of therapist self-compassion can reduce unhelpful cognitive processes such as worry, rumination and self-criticism whilst increasing self-reflection, attentional flexibility and approach behaviour. Identifying, and working with, blocks to compassion is important when cultivating clinician self-compassion Therapist self-practice of compassion-focused exercises can provide important insights into the nature of compassion and its cultivation in clients.

Maternal prenatal psychological distress and temperament in 1-4 month old infants - A study in a non-western population.

In this longitudinal study, conducted in women attending antenatal visits at the obstetrics and gynecology clinic of a general hospital in Bangalore, India, we aimed to assess the relationship between prenatal distress in mothers, and maternal report of infant temperament at four months. 100 mothers with normal full term deliveries completed the General Health Questionnaire-28 item version (GHQ) in the third trimester and postnatally. Salivary cortisol and temperament (using the Early Infancy Temperament Questionnaire - EITQ) were assessed in their infants aged 1-4 months. In this study, maternal prenatal psychological distress was not significantly associated with maternal report of difficult temperament in infants. Infants of mothers who were a negative screen for psychological distress (GHQ<7), n=85 had higher scores on the adaptability and approach dimensions of temperament. Infant salivary cortisol was significantly higher in infants with higher intensity scores. These results introduce the possibility of cultural differences in the relationship between prenatal distress in the mother and infant temperament. These could be factors linked to child rearing practices or to the measures employed to study infant temperament. These findings derive from a small sample with few mothers with psychological distress, and need replication in a larger sample.

Antidepressant-placebo differences in 16 clinical trials over 10 years at a single site: role of baseline severity.

BACKGROUND: Antidepressant-placebo differences observed in randomized double-blind, placebo-controlled clinical trials have always been relatively small and have further declined during the past three decades. During this same time, a decrease in patient severity of symptoms at baseline has occurred. The current study was designed to examine antidepressant-placebo difference scores and baseline severity of depression over a 10-year period in a sample of depressed patients enrolled at a single clinical trial site. METHODS: We analyzed data from a total of 462 patients who participated in 16 clinical trials at the Northwest Clinical Research Center, Bellevue, WA between 1995 and 2004. NWCRC collaborated with study sponsors to unblind the randomization codes from 16 trials for 293 patients assigned to antidepressants and 169 patients assigned to placebo. RESULTS: The mean total baseline HAM-D17 scores were relatively high and stable (mean of 24.7, range 22.2-27.4). The outcome, as measured by changes in mean total HAM-D17 scores between antidepressant and placebo, were similar and were not related to the year of the conduct of the trial. Furthermore, the baseline severity of depressive symptoms, and BMI played a significant role in the outcome with antidepressants and not with placebo. CONCLUSIONS: Our results show that no diminution of drug-placebo difference occurs over time when baseline severity remains constant. As such, they support the importance of depression severity as a determinant of antidepressant-placebo difference.

Why has the antidepressant-placebo difference in antidepressant clinical trials diminished over the past three decades?

The increasing rate of failure of antidepressant clinical trials has led to the assertion that antidepressants do not have meaningful clinical benefits. Our hypothesis was that the decrease in antidepressant-placebo differences in antidepressant clinical trials over the past three decades could be explained by changes in research design features rather than a lack of potency of the antidepressants being tested. We collected data from 130 double blind placebo controlled antidepressant clinical trials conducted between 1981 and 2008 that included 35,122 depressed patients with 23,157 patients assigned to antidepressants and 11,965 assigned to placebo. We conducted a hierarchical regression analysis of change in HAM-D scores in antidepressant and placebo groups separately with year of publication, and research design features as independent variables. We found that antidepressant-placebo differences in antidepressant clinical trials have declined markedly over the past three decades. Decline in change scores in the antidepressant group was related to mean total baseline HAM-D scores in the trial, the version of HAM-D used, and duration of trial. Similarly, decline in change scores in the placebo group was related to mean total baseline HAM-D scores, duration of trial, and year of publication. Overall, we found that antidepressant-placebo differences were statistically significantly higher in trials that used HAM-D 21 rather than HAM-D 17 and in trials that lasted 6 weeks or less. These data suggest that, apart from the efficacy of the antidepressant being tested, factors such as baseline HAM-D scores, version of HAM-D used and duration of trial have a significant impact on outcome. As such a clinician's assessment of the usefulness of antidepressants should not be based solely on the results of such clinical trials. In the meantime there is a need for continuing research to improve the methodology of antidepressant clinical trials. These data suggest that many aspects of the design of antidepressant trials have a significant impact on outcome. Further, these data suggest that the results of more recent placebo controlled trials do not adequately inform clinicians about the potential utility of antidepressants.

Mortality risk in patients with schizophrenia participating in premarketing atypical antipsychotic clinical trials.

OBJECTIVE: Given the concern that mortality rates may be increased in geriatric patients exposed to atypical antipsychotic agents, we assessed mortality rates for adult patients with schizophrenia assigned to an investigational antipsychotic (olanzapine, quetiapine, risperidone, or ziprasidone), a control antipsychotic (haloperidol or chlorpromazine), or placebo in preapproval clinical development programs to assess relative risk with atypical antipsychotics as compared to typical antipsychotics or placebo. METHOD: We reviewed safety data (from clinical trials conducted from approximately 1982 to 2002) for 16,791 adult patients with schizophrenia (DSM-III or DSM-IV criteria) in U.S. Food and Drug Administration (FDA) Summary Basis of Approval (SBA) reports for 6 antipsychotic drugs. Mortality rates were calculated for each treatment group (investigational agent, active control, or placebo) on the basis of patient exposure years (PEY) and gross mortality. We compared the differences in mortality rates between placebo and investigational agents, active controls, and all antipsychotic drugs combined using odds ratios. RESULTS: By PEY analysis, the mortality rate for patients assigned to placebo treatment was significantly higher (p < .05) than for either the investigational antipsychotic (OR = 0.23, 95% CI = 0.13 to 0.45) or the active control group (OR = 0.19, 95% CI = 0.08 to 0.45). Although rates based on gross mortality were also higher with placebo treatment, statistical significance was only seen when comparing patients assigned to placebo with those assigned to the active control antipsychotic group (OR = 0.35, 95% CI = 0.15 to 0.82). CONCLUSIONS: Despite reported excess mortality with antipsychotic use in elderly patients with dementia, SBA data did not reveal a similar increased risk of antipsychotics in adult patients with schizophrenia. However, methodological limitations of the FDA SBA reports may affect the generalizability of these findings.

Psychiatric diagnosis and clinical trial completion rates: analysis of the FDA SBA reports.

Completion rates may affect the safety and efficacy evaluations of psychotropics. We assessed completion rates in clinical trials evaluating psychotropics for five psychiatric disorders. We also examined differences in completion rates between psychotropics and placebo in each diagnostic category. We reviewed clinical data in the Food and Drug Administration summary basis of approval reports for 20 psychotropics evaluated for the treatment of depression, schizophrenia, obsessive compulsive disorder (OCD), generalized anxiety disorder (GAD), or panic disorder, consisting of 19 710 patients. Patients with OCD had the highest completion rates (78.0%), followed by patients with panic disorder (74.4%), GAD (69.2%), depression (64.7%) and schizophrenia (49.0%). Patients assigned to placebo had significantly lower completion rates in antipsychotic clinical trials. Patients assigned to psychotropics in OCD trials had significantly lower completion rates compared to the placebo group. A greater number of early terminations relating to a lack of efficacy was seen among patients assigned to placebo (17.4%) compared with patients assigned to psychotropics (12.2%). A greater number of early terminations relating to adverse events was seen among patients assigned to psychotropics (10.4%) compared with patients assigned to placebo (4.8%). Our findings suggest that psychiatric diagnosis and treatment assignment (placebo vs psychotropic) were associated with completion rates in clinical trials. These findings may help in the design of future psychopharmacology clinical trials.

Seizure incidence in psychopharmacological clinical trials: an analysis of Food and Drug Administration (FDA) summary basis of approval reports.

BACKGROUND: Clinical trial data provide an approach to the investigation of the effects of psychopharmacological agents, and psychiatric disorders themselves, on seizure threshold. METHODS: We accessed public domain data from Food and Drug Administration (FDA) Phase II and III clinical trials as Summary Basis of Approval (SBA) reports that noted seizure incidence in trials of psychotropic drugs approved in the United States between 1985 and 2004, involving a total of 75,873 patients. We compared seizure incidence among active drug and placebo groups in psychopharmacological clinical trials and the published rates of unprovoked seizures in the general population. RESULTS: Increased seizure incidence was observed with antipsychotics that was accounted for by clozapine and olanzapine, and with drugs indicated for the treatment of OCD that was accounted for by clomipramine. Alprazolam, bupropion immediate release (IR) form, and quetiapine were also associated with higher seizure incidence. The incidence of seizures was significantly lower among patients assigned to antidepressants compared to placebo (standardized incidence ratio = .48; 95% CI, .36- .61). In patients assigned to placebo, seizure incidence was greater than the published incidence of unprovoked seizures in community nonpatient samples. CONCLUSIONS: Proconvulsant effects are associated with a subgroup of psychotropic drugs. Second-generation antidepressants other than bupropion have an apparent anticonvulsant effect. Depression, psychotic disorders, and OCD are associated with reduced seizure threshold.

BMI, sex, and antidepressant response.

BACKGROUND: Investigators have examined potential mechanisms for the observed differences between men and women in antidepressant response. However, to date no studies have measured the impact of body mass index (BMI) on men's and women's response to selective serotonin re-uptake inhibitors or placebo. METHODS: We evaluated the response to antidepressants and placebo of 274 non-obese (BMI<30) and obese (BMI>30) depressed outpatients participating in Phase II-IV clinical trials. After categorizing men and women into their respective BMI groups, we measured the amount of change each group experienced from baseline to the final visit using the HAM-D-17 and MADRS ratings scales. RESULTS: Compared to women, men assigned to an antidepressant had a significantly lower mean total change on both the HAM-D-17 [non-obese, F(1,88)=5.292, p=0.024; obese, F(1,39)=7.040; p=0.012] and the MADRS [non-obese, F(1,66)=4.049, p=0.048; obese, F(1,27)=8.631, p=0.007]. In fact, obese men showed the smallest difference in antidepressant-placebo response. The results of the ANCOVAs indicated significant main effects of treatment (placebo vs. antidepressant), sex of the patient, and BMI category as well as a significant interaction between all three variables. LIMITATIONS: Patients participating in clinical trials are not necessarily representative of the entire depressed population. In addition, our results include only SSRIs, not other antidepressants. CONCLUSION: Compared to the rest of the depressed sample the subgroup of depressed obese men (n=40) showed little or no therapeutic benefit with SSRI antidepressants. Although our findings may have important clinical implications, replication and further research is warranted in order to understand their underlying mechanisms and their pertinence to dosing strategies.

Relationship between depression severity entry criteria and antidepressant clinical trial outcomes.

BACKGROUND: We assessed whether increasing the minimum prerandomization Hamilton Depression Rating Scale (HAM-D) score to enrich the severity of the depressed sample affects antidepressant trial outcome. METHODS: Using the Food and Drug Administration Summary Basis of Approval reports, we examined outcome data from 51 clinical trials (11,270 depressed patients) evaluating 10 investigational antidepressants. RESULTS: Using four categories of trials with increasing minimum HAM-D entry trial criteria, we found no statistically significant relationship between prerandomization categories and trial outcome overall. Although there were minor differences in trial outcome among the three categories with the lowest entry criteria (mean 49%, range, 44.4%-50.0%), the antidepressant trials requiring the highest prerandomization HAM-D score (> or = 20 HAM-D 17) had the lowest frequency of positive outcomes (20%), chi(2) = 4.04, df =1, p = .04. Paradoxically, high entry criteria requirements failed to increase reliably actual mean total prerandomization HAM-D scores, although mean total prerandomization HAM-D scores and use of flexible dosing were associated with higher rates of positive outcome. A greater placebo response was seen in trials requiring higher prerandomization depressive symptoms. CONCLUSIONS: In summary, requiring higher prerandomization depressive symptoms was not associated with an increased rate of favorable outcomes among these 51 antidepressant trials.

Suicide risk analysis among patients assigned to psychotropics and placebo.

Based on available data, it is unclear if the suicide risk is significantly different among clinical trial patients assigned to psychotropics compared with patients assigned to placebo, among patients with various psychiatric diagnoses. This study was to investigate whether patients assigned to psychotropics would have a similar suicide risk as measured by the frequency of completed suicides and suicide attempts, compared to those patients assigned to placebo. The U.S. Food and Drug Administration database of controlled clinical trials for 9 antidepressants, 3 antipsychotics, and 7 anxiolytics provided data for comparing suicides and suicide attempts among 46,575 patients assigned to psychotropics or placebo. The Poisson Regression analysis suggested that there were no significant differences in rates of suicide and suicide attempts among patients assigned to the psychotropics or placebo. These findings suggest that the high suicide risk among clinical trial participants is not significantly affected by psychotropics.

Sex differences in antidepressant response in recent antidepressant clinical trials.

Some previous reports suggest that women respond differently than men to antidepressant treatment. Much of this literature compares men and women's response to tricyclics to that of newer antidepressants (SSRIs, SNRI), or only examines one particular antidepressant. This study compares men and women's responses to 6 newer antidepressants. A total of 15 randomized, placebo-controlled trials that included 323 depressed patients were examined for sex differences in antidepressant treatment response. Women had a significantly greater response than men to SSRI antidepressants. A similar trend was seen for those assigned to an SNRI antidepressant, although not to the same extent as with SSRI antidepressants. Although these gender differences in treatment response are not large enough to suggest that gender should guide the clinical use of SSRI and SNRI antidepressants, the results do have implications for the design and interpretation of antidepressant clinical trials. These findings also raise the possibility that antidepressants may work somewhat differently in men and women.

Magnitude of placebo response and drug-placebo differences across psychiatric disorders.

BACKGROUND: Placebo response, drug response, and drug-placebo differences appear to vary among psychiatric conditions. METHOD: We evaluated the Food and Drug Administration (FDA) Summary Basis of Approval (SBA) reports to compare the magnitude of placebo response, magnitude of psychotopic drug response, and drug placebo differences among various diagnostic groups such as depression, anxiety, and psychotic disorders. RESULTS: Six diagnostic groups (psychosis, obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), depression, post-traumatic stress disorder, panic) varied in response to both placebo and active drug treatments. Response to placebo was high among patients participating in GAD, depression, and panic disorder clinical trials. Conversely, patients participating in psychotic disorder and OCD trials experienced low response to placebo. CONCLUSION: Our findings indicate that the magnitude of placebo response and drug response were heterogeneous and were statistically significantly different among various psychiatric disorders. Although a noticeable degree of heterogeneity was detected in the drug-placebo ratio among various disorders, the differences did not reach statistical significance. This finding suggests that placebo use should be continued for newer agents being tested for all of the psychiatric disorders. These findings may help in the development of psychopharmacology trial designs and in the deliberations of ethics committees.

Severity of depressive symptoms and response to antidepressants and placebo in antidepressant trials.

Although increased pre-treatment severity of depressive symptoms is thought to suggest better outcome with tricyclic antidepressants, it is unclear if such a pattern exists among those depressed patients treated with newer antidepressants. If such a pattern with newer antidepressants were observed, it would have implications for the design and conduct of future antidepressant trials. We reviewed the data from 329 depressed adult patients that were part of 15 multi-center, randomized, double blind, placebo-controlled antidepressant clinical trials at our center. Based on patients' pre-treatment scores on the 17-item Hamilton Depression Rating Scale (HAM-D), patients were sub-grouped to one of four severity of depression groups: low moderate, high moderate, moderately severe, and severe. The effect size was 0.51 in the low moderate group, 0.54 in the high moderate group, 0.77 in the moderately severe group and 1.09 in the severe group. An analysis of variance revealed a statistically significant interaction between treatment and severity of depressive symptoms. A correlational analysis revealed that in the group of depressed patients assigned to antidepressants, higher levels of pre-treatment depressive symptoms were significantly associated with greater changes in response to antidepressant treatment. Although a similar pattern was seen among the depressed patients assigned to placebo, it did not reach statistical significance. The results of this study suggest that antidepressant-placebo differences may be larger among those depressed outpatients with higher pre-treatment HAM-D scores compared to those depressed outpatients with lower pre-treatment scores. These findings may help in the design of future antidepressant clinical trials.

Research design features and patient characteristics associated with the outcome of antidepressant clinical trials.

OBJECTIVE: The authors examined which, if any, research design features and patient characteristics would significantly differ between successful and unsuccessful antidepressant trials. METHOD: Clinical trial data were reviewed for nine antidepressants approved by the Food and Drug Administration between 1985 and 2000. From the antidepressant research programs on these medications, 52 clinical trials were included in the study. The authors evaluated trial design features, patient characteristics, and difference in response between placebo and antidepressant. RESULTS: Nine trial design features and patient characteristics were present in the research programs for all nine of the antidepressants. The severity of depressive symptoms before patient randomization, the dosing schedule (flexible versus fixed), the number of treatment arms, and the percentage of female patients were significantly associated with the difference in response to antidepressant and placebo. The duration of the antidepressant trial, number of patients per treatment arm, number of sites, and mean age of the patients were similar in successful trials (with a greater antidepressant-placebo difference) and less successful trials (with a smaller antidepressant-placebo difference). CONCLUSIONS: These findings may help in the design of future antidepressant trials.

Relative sensitivity of the Montgomery-Asberg depression rating scale, the Hamilton depression rating scale and the Clinical Global Impressions rating scale in antidepressant clinical trials: a replication analysis.

The present study replicates a previous study in which we found that the less frequently used Montgomery-Asberg Depression Rating Scale (MADRS) is as sensitive an instrument in detecting antidepressant-placebo differences in antidepressant clinical trials as the more widely used Hamilton Depression (HAM-D) rating scale. The Clinical Global Impressions Rating Scale for Severity (CGI-S) was also similar to the other two scales. A retrospective chart review was performed on the records of 139 depressed adult patients who participated in six randomized, placebo-controlled, double-blind antidepressant clinical trials at the North-west Clinical Research Centre between 1996 and 2003. The effect size (measured as the mean change in rating with antidepressants minus the mean change for placebo divided by the pooled SD of change) was 0.68 with MADRS, 0.54 with CGI-S and 0.57 with HAM-D. A correlation analysis also revealed a significant positive relationships between baseline MADRS and HAM-D and final MADRS and HAM-D for the total sample, placebo group, and antidepressant group (P<0.01). Further research is needed to examine which scale is the most appropriate to use for each particular antidepressant clinical trial.

The relationship of sociotropy and autonomy to posttraumatic cognitions and PTSD symptomatology in trauma survivors.

The current study examined relationships between sociotropic and autonomous personality styles and posttraumatic stress disorder (PTSD) symptomatology following trauma as well as specific posttraumatic cognitions that have been shown to characterize individuals with PTSD. Self-report data were collected in a sample of 156 college students indicating a history of traumatic experience. Significant relationships were found between symptoms of PTSD and depression and measures of sociotropy, autonomy, and negative posttraumatic beliefs about self and world. Additionally, measures of autonomy and negative posttraumatic thoughts improved prediction of PTSD symptom level after controlling for depressive symptoms.