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Biomedical subjects

Jonathan Davidson

Publications and source records attributed to Jonathan Davidson.

14 recordsLinked to original sources

Treatment of posttraumatic stress disorder with venlafaxine extended release: a 6-month randomized controlled trial.

CONTEXT: No large-scale posttraumatic stress disorder drug trials have been conducted to evaluate treatment effects beyond 12 weeks outside of those with selective serotonin reuptake inhibitors. OBJECTIVE: To evaluate the efficacy of venlafaxine extended release (ER), a serotonin norepinephrine reuptake inhibitor, in posttraumatic stress disorder. DESIGN: 6-month, double-blind, placebo-controlled trial. SETTING: International study at 56 sites. Patients Adult outpatients (N = 329) with a primary diagnosis of posttraumatic stress disorder as defined in the DSM-IV, symptoms for 6 months or longer, and a 17-item Clinician-Administered Posttraumatic Stress Disorder Scale score of 60 or higher. Intervention Patients randomly assigned to receive flexible doses of venlafaxine ER (37.5-300 mg/d) or placebo for 24 weeks. MAIN OUTCOME MEASURES: Primary measure was the change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale score. Secondary measures included remission, defined as a Clinician-Administered Posttraumatic Stress Disorder Scale score of 20 or lower, and changes in symptom cluster scores, frequency of remission, and time to remission. Measures of stress vulnerability, resilience, depression, quality of life, functioning, and global illness severity were also taken. RESULTS: Mean changes from baseline in Clinician-Administered Posttraumatic Stress Disorder Scale total scores at end point were -51.7 for venlafaxine ER and -43.9 for placebo (P = .006). Improvement was significantly greater for the venlafaxine ER group than for the placebo group in cluster scores for reexperiencing (P = .008) and avoidance/numbing (P = .006), but not for hyperarousal. Remission rates were 50.9% for venlafaxine ER and 37.5% for placebo (P = .01). The venlafaxine ER group also showed significantly greater improvement at end point than the placebo group (P<.05) on all other reported outcome measures. The mean maximum daily dose of venlafaxine ER was 221.5 mg/d. Withdrawal rates were similar between groups with no significant difference in dropouts attributable to adverse events. CONCLUSION: In this study, venlafaxine ER was effective and well tolerated in short-term and continuation treatment of patients with posttraumatic stress disorder.

Adult↗

Venlafaxine extended release in posttraumatic stress disorder: a sertraline- and placebo-controlled study.

This 12-week, double-blind, multicenter trial evaluated the efficacy of venlafaxine extended release (ER), sertraline, and placebo in adult outpatients (N = 538) with a primary diagnosis of posttraumatic stress disorder (PTSD), as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, symptoms for 6 months or more and 17-item Clinician-administered PTSD Scale (CAPS-SX17) score of 60 or more. Patients were randomly assigned to receive placebo or flexible doses of venlafaxine ER (37.5-300 mg/d) or sertraline (25-200 mg/d) for 12 weeks or less. The primary outcome was the baseline-to-end point change in total CAPS-SX17 score (last observation carried forward). Secondary measures included CAPS-SX17 symptom cluster scores for reexperiencing/intrusion, avoidance/numbing, and hyperarousal; frequency of remission (CAPS-SX17 < or =20); and changes in Davidson Trauma Scale total score and symptom cluster scores for avoidance/numbing, hyperarousal, and reexperiencing/intrusion. Mean changes in CAPS-SX17 scores were -41.8, -39.4, and -33.9 for venlafaxine ER (P < 0.05 vs. placebo), sertraline, and placebo, respectively. Mean changes for venlafaxine ER, sertraline, and placebo in CAPS-SX17 cluster scores were -13.0, -11.7, and -11.0 for reexperiencing; -17.1, -16.8, and -13.7 (P < 0.05 both active treatments vs. placebo) for avoidance/numbing; and -11.8, -10.9, and -9.2 (P < 0.05 venlafaxine vs. placebo) for hyperarousal. Week 12 remission rates were venlafaxine ER 30.2% (P < 0.05 vs. placebo), sertraline 24.3%, and placebo 19.6%. The venlafaxine ER group had significantly better Davidson Trauma Scale total and cluster scores than placebo. Mean maximum daily doses were 225-mg venlafaxine ER and 151-mg sertraline. Both treatments were generally well tolerated. Study results suggest that venlafaxine ER is effective and well tolerated in the short-term treatment of PTSD.

Adolescent↗

Effects of paroxetine and venlafaxine XR on heart rate variability in depression.

Depressed patients may exhibit reduced heart rate variability (HRV), and antidepressants which block norepinephrine uptake may also lower HRV. This study compared paroxetine (PAR) and venlafaxine XR (VEN-XR) on HRV. Outpatients were randomly assigned to double-blind treatment with PAR up to 40 mg or VEN-XR up to 225 mg daily. HRV measures of parasympathetic control consisted of change in R-R interval during forced 10-second breaths and respiratory sinus arrhythmia (RSA) during paced breathing. Ex vivo estimates of serotonin and norepinephrine transporter occupancy were obtained before and after treatment, as were measures of depression, anxiety, and resilience. Plasma drug concentrations were measured at end point. Forty-nine patients entered treatment; 44 of whom were evaluable (n = 22 per group). Significant within-group reductions were noted in R-R interval variation and in RSA after VEN-XR only. Between-group analyses showed significant group-by-time interaction, with greater reduction in R-R interval variation and in RSA for VEN-XR compared with PAR. Improvement in resiliency correlated significantly with norepinephrine transporter occupancy for VEN-XR. Further comparisons of selective serotonin reuptake inhibitor and serotonin and norepinephrine reuptake inhibitor drugs on HRV are warranted.

Adult↗

A brief screening instrument to detect posttraumatic stress disorder in outpatient gynecology.

OBJECTIVE: Posttraumatic stress disorder (PTSD) is a serious anxiety disorder triggered by the experience of trauma. One in 4 individuals exposed to trauma will develop PTSD. Victims of trauma are frequent users of health care, but screening is rarely done and most sequelae remain undetected. Our objectives were 1) to document the prevalence of a trauma history among women seeking routine gynecologic care and 2) to evaluate a 4-item screening instrument for PTSD for triaging women with a trauma history for further evaluation. METHODS: We conducted a cross-sectional survey of women presenting to the University of North Carolina outpatient gynecology clinic for an annual examination. Written surveys included medical history and health status, trauma history (including type), and PTSD symptoms using the screening instrument. Patients with trauma who agreed to further participation received a structured clinical interview to diagnose PTSD. RESULTS: Seventy-six percent of patients (N = 292) completed the survey, and 88 (30%) reported a history of 1 or more traumatic event or events. Thirty-two of the 88 completed the psychiatric assessment, and 25 of 32 (78%) met Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria for PTSD. Mean age was 34 years, 49% were African American, and 46% were unmarried. Compared with the structured clinical interview, the screening instrument performed with a sensitivity of 72% (95% confidence interval [CI] 0.51-0.88) and a specificity of 71% (95% CI 0.29-0.96), corresponding to a positive likelihood ratio of 2.52 (95% CI 0.76-8.34) and a negative likelihood ratio of 0.39 (95% CI 0.18-0.86). CONCLUSION: Trauma was common in this population. Including a screening instrument for trauma and PTSD on clinic intake surveys has promise for use as a triage tool. Use of such an instrument could meaningfully increase detection of PTSD among women receiving routine preventive care. LEVEL OF EVIDENCE: III

Adult↗

Fluvoxamine-controlled release formulation for the treatment of generalized social anxiety disorder.

BACKGROUND: Generalized social anxiety disorder is a highly prevalent anxiety disorder with deleterious effects on social and family relationships, as well as work performance. We report the results of a multicenter, randomized, placebo-controlled trial comparing the efficacy, safety, and tolerability of fluvoxamine controlled release (CR) to placebo in patients with generalized social anxiety disorder. METHODS: A total of 279 adult patients meeting all inclusion/exclusion criteria was recruited at 23 United States sites and randomly assigned to receive either fluvoxamine CR (100-300 mg/d) or placebo for 12 weeks. The dose could be increased, based on efficacy and tolerability, in increments of 50 mg/d at weekly intervals. The dosage remained constant during weeks 6 to 12. RESULTS: Treatment with fluvoxamine CR resulted in statistically and clinically significant improvements in symptoms associated with generalized social anxiety disorder as early as week 4 on the Liebowitz Social Anxiety Scale and the Clinical Global Impression Scale Global Improvement, and at week 6 on the Sheehan Disability Scale, Clinical Global Impression Scale Severity of Illness and the Patient Global Impression of Improvement Scale. The most frequent adverse events reported by patients on fluvoxamine CR were headache, nausea, somnolence, and insomnia. No weight gain was observed for either treatment group, and at end point, there were no differences between treatments on overall sexual function, as measured by the Arizona Sexual Experience Scale. CONCLUSIONS: Both physician and patient-rated scales indicate that fluvoxamine CR is effective and safe for the treatment of generalized social anxiety disorder.

Adolescent↗

Social support and religiosity as coping strategies for anxiety in hospitalized cardiac patients.

BACKGROUND: Prospective studies have demonstrated that anxiety is associated with an increased risk of mortality and sudden cardiac death. There is therefore a need to understand what factors contribute to anxiety in patients with coronary heart disease (CHD). PURPOSE: This study examined whether social support and religiosity are individually or jointly associated with lower anxiety in cardiac patients. METHODS: Anxiety, perceived social support, and religiosity were assessed in 228 (71% male, 29% female) hospitalized CHD patients aged 62 +- 11 years. RESULTS: Higher levels of social support were related to lower levels of state and trait anxiety (state anxiety, r = -.26, p < .01; trait anxiety, r = -.30, p < .01;). Religiosity was related to lower state anxiety (r = -.27, p < .01) but only modestly related to lower trait anxiety (trait anxiety, r = -.18, p < .01). The relationship between religiosity and trait anxiety was no longer significant after controlling for social support (p = .26). CONCLUSIONS: These findings suggest that religiosity and social support provide a buffer against anxiety in CHD patients and that higher levels of social support may account for the relationship between religiosity and trait anxiety. These findings underscore the importance of social support and religiosity as buffers against distress, with possible implications for prognosis in a patient group where high levels of anxiety appear to confer increased risk of mortality.

Adaptation, Psychological↗

Paroxetine in the treatment of post-traumatic stress disorder: pooled analysis of placebo-controlled studies.

Post-traumatic stress disorder (PTSD) is increasingly understood to be a medical disorder characterised by particular psychobiological dysfunctions that respond to specific treatments. Paroxetine is a selective serotonin re-uptake inhibitor that has been found effective in the treatment of major depression as well as a range of anxiety disorders. This paper reviews data on the use of paroxetine for the treatment of adult PTSD. There have been three 12-week, placebo-controlled studies of paroxetine in PTSD. As these followed a partly similar design, a pooled analysis of the studies is possible and is reported here. Paroxetine is effective in the short-term treatment of PTSD, resulting in significantly better response and remission rates than placebo, improving sleep disturbance and reducing each of the symptom clusters of PTSD, as well as the disability associated with this condition. The medication is effective in both male and female PTSD patients and whether or not there are comorbid disorders such as depression.

Administration, Oral↗

Chronic pain and depression. I. Classification of depression in chronic low back pain patients.

An association between chronic pain and depression has been recognized for a long time. However, the exact nature of this relationship remains unclear. The authors studied 71 patients for affective disorders and schizophrenia-lifetime version (SADS-L). Based on the interviews, we were able to identify 31 patients with major depression, 8 patients with minor depression and 18 with intermittent depressive disorder as defined by Research Diagnostic Criteria. Item analysis using the Hamilton Depression Rating Scale and the Montgomery-Asberg Depression Rating Scale showed that the items did not discriminate in patients with major depression the presence of organic findings. However, most of the items significantly discriminated between the various types of depression and patients without depression. The occurrence of clearly defined depression points to several avenues of research aimed at clarifying the incidence etiology and treatment of depression in these patients.

Adult↗

Chronic pain and depression. II. Symptoms of anxiety in chronic low back pain patients and their relationship to subtypes of depression.

The relationship between anxiety and chronic pain has been poorly studied. The authors studied the occurrence of symptoms of anxiety in chronic low back pain patients. Anxious mood and other symptoms of anxiety were commonly seen in patients with chronic low back pain. Symptoms of anxiety were more common in patients with depression, especially those with major depression. Anxious mood, tension and general somatic symptoms of the sensory type were more common than any other type of anxiety symptoms. The authors discuss the potential role of anxiety in chronic pain patients.

Adult↗

Improvement of anger at one week predicts the effects of sertraline and placebo in PTSD.

In previous work we demonstrated an early, robust and sustained effect for sertraline vs placebo on irritability and anger in subjects with PTSD. In this report, we explore the same dataset to assess whether a clinician might usefully predict ultimate response to sertraline, on the basis of its effect upon anger after one week. Three hundred and eighteen subjects were assessed. Outcome was measured by whether or not the score was reduced by at least 50% from baseline. Ordinary least squares regression was used to estimate the effects of change in anger at one week. Logistic regression was applied to estimate the effects on odds of a 50% drop in score. Cut points were developed for one-week change scores on anger for sertraline and placebo. The best cut point was selected as predictive of non-response, i.e. a cue suggesting that treatment switch would be in order. An increase in anger of 30% at one-week best predicted the likelihood of not responding to treatment in both the drug and placebo groups. Twenty-five percent of all non-responders were incorrectly identified, while only 7% of all improvers were incorrectly categorized as non-responders using this cutoff. Our findings imply that, for patients similar to those in this study, an increase in anger after one week of treatment might be one factor to consider when making a decision about continuation of the medication.

Adolescent↗

Nonpharmacologic treatments for depression in patients with coronary heart disease.

OBJECTIVES: We review nonpharmacologic treatments for depression in patients with coronary heart disease (CHD), including psychological therapies such as cognitive behavior therapy (CBT) and interpersonal therapy (IPT), aerobic exercise, St. John's wort (SJW), essential fatty acids (EFAs), S-Adenosylmethionine (SAMe), acupuncture, and chromium picolinate (CP). METHOD: Medline searches and reviews of bibliographies were used to identify relevant articles. Each treatment was reviewed with particular attention paid to empirical support, as well as to potential mechanisms of action that might affect not only depression but also CHD endpoints. RESULTS: Nearly all randomized controlled trials (RCTs) of depression treatments have been conducted with non-CHD patients. These studies have provided the most support for psychological treatments, particularly CBT and IPT. Aerobic exercise, SJW, and SAMe also have considerable empirical support in otherwise healthy persons, but SJW may have undesirable side effects for CHD patients. Data for EFAs, CP, and acupuncture are limited; however, the use of aerobic exercise shows considerable promise for cardiac patients. CONCLUSIONS: There are few RCTs of patients with clinical depression and CHD, and those that exist have significant methodological limitations. Nonetheless, there is preliminary evidence that nonpharmacologic treatments are effective for cardiac patients with depression. In terms of reducing depression, the most evidence exists for psychological treatments, particularly CBT and IPT. However, there is little evidence that such treatment would also improve CHD risk factors. Aerobic exercise offers more promise to improve both mental and physical health due to its effect on cardiovascular risk factors and outcomes and thus warrants particular attention in future trials.

Acupuncture Therapy↗