FDA Approves Duloxetine HCI for the Management of Fibromyalgia
The United States Food and Drug Administration approved duloxetine HCI (Cymbalta, Eli Lilly) for the management of fibromyalgia. Fibromyalgia is estimated to affect 2% of the United States population, with the majority of diagnoses being made in women.
Approval was based on the results of two 3-month clinical trials representing 874 patients with fibromyalgia. In week 1 of both studies, the duloxetine group demonstrated significant improvement in pain compared to placebo, according to the Brief Pain Inventory (BPI), a 24-hour average pain scale. Fifty-one percent and 55% of patients on duloxetine of the two respective studies experienced a 30% improvement (the threshold for clinical pain improvement) on the BPI by endpoint. Also, at both trials’ endpoint, 65% and 66% of patients on duloxetine 60 mg/day reported overall symptomatic improvement according to the Patient Global Impression of Improvement scores.
The most common adverse events associated with duloxetine include nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation.
For more information, please consult the medication’s full prescribing information. (www.insidecymbalta.com). —LS
Acute Stress Disorder and PTSD Diagnoses May Predict Future Onset of Chronic PTSD
Survival after a major burn injury has substantially improved over the past 20 years. However, there is evidence of psychological distress and disorders following this type of injury, including acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). A study by Jodi B. A. McKibben, PhD, and colleagues, considered whether an ASD diagnosis, with its dissociative symptoms, is a better predictor of chronic PTSD than a PTSD diagnosis made at the same time in a major burn population.
The study involved 178 hospitalized adult patients (73.6% male; 23.4% female) with major burns treated at Johns Hopkins Burn Center. Scores from self-report measures, including the Stanford Acute Stress Reaction Questionnaire (SASRQ), Davidson Trauma Scale (DTS), and Brief Symptom Inventory, were used to determine biopsychosocial function at five time periods. In accordance with criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the SASRQ assessed ASD and PTSD at discharge from the center (n=178) while the DTS assessed PTSD at 1 (n=151), 6 (n=111), 12 (n=105), and 24 (n=71) months after discharge. Results found that both ASD and PTSD diagnoses at discharge were major indicators of future onset of PTSD at 1, 6, and 12 months, but not at 24 months, with no significant differences in predictive ability at any time.
McKibben and colleagues suggest future research to measure all ASD and PTSD criteria at discharge, as the current study neglected to assess two PTSD avoidance criteria (ie, decreased interested/participation and sense of limited future). In addition, structured interviews assessing ASD and PTSD as well as efforts to reduce attrition rates in burn populations from other hospitals would further validate and address the generalizability of results. (APA 2008; Poster NR 6-069). –ML
Parents With Bipolar Disorder at Increased Risk for Substance Use Disorders Than Healthy Parents
According to the National Institute of Mental Health, bipolar disorder is often comorbid with substance use disorders, which may be caused by bipolar mood symptoms often exacerbated by alcohol and drug use, a patient’s intent to self-medicate symptoms, and other risk factors related to both bipolar disorder and substance abuse. Research has shown that substance use disorder risk is increased among parents of youths with bipolar disorder, particularly if parents also have bipolar disorder.
However, there have been few studies that investigate the prevalence of substance use disorders among parents with bipolar disorder, separate from the mental health status of the child. The prevalence of substance use disorders may be useful for clinicians, as parental substance use has been shown to increase the risk of child maltreatment and impairment.
Benjamin I. Goldstein, MD, PhD, of the Western Psychiatric Institute and Clinic at the University of Pittsburgh School of Medicine in Pennsylvania, and colleagues, evaluated 448 adult parents with and without bipolar disorder to determine rates of substance use disorder prevalence. Patients were divided by bipolar disorder symptomology (n=274: Type I, n=175; Type II, n=83; not otherwise specified, n=16) or presence of other psychiatric conditions (n=112), and were compared to participants without mental health disorder history (n=62).
Patients were assessed for bipolar disorder via the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID-IV). All children of parents in the study were ≤18 years of age, and 79% of parents were female. Other patient demographic and clinical information regarding substance use was assessed by researchers via interview at the study’s beginning. Demographic variables significantly associated with lifetime prevalence of substance use disorder were included in analysis.
Goldstein and colleagues found that substance use disorders were significantly more prevalent for patients with bipolar disorder (64%) when compared to patients with other psychiatric disorders (40%) or parents without bipolar disorder (21%). This result remained after the authors controlled for between-group differences in socioeconomic and marital status as well as race. When compared to healthy parents with substance use disorders, patients with bipolar disorder showed significantly greater prevalence of alcohol abuse (59% vs. 31%), and cocaine (22% vs. 8%) and opioid (7% vs. 0%) dependence.
In addition, the presence of a substance use disorder in one parent was significantly associated with the development of a substance use disorder in another parent despite bipolar disorder prevalence. Goldstein and colleagues concluded that parents with bipolar disorder are at a greatly increased risk for developing substance use disorders, which may confer genetic and environmental risk of negative outcome for the child.
“It is important for primary care phyisicans (PCPs) who work with families to know that parents with bipolar disorder have increased likelihood of having substance use disorders, and there is also increased likelihood of substance abuse in the other parent. Careful screening for excessive drug or alcohol use is warranted, and PCPs should encourage parents to seek specific treatment for substance abuse ideally in a manner that is integrated with their treatment for bipolar disorder,” Dr. Goldstein said. “Previous studies have found that children of parents who abuse substances are exposed to two-fold increased risk of maltreatment, and the risk is greater when both parents abuse substances. The hope is that early identification of parental substance use disorders and referral for appropriate treatment may decrease this risk to children.”
The authors recommend researchers conduct long-term, prospective studies that examine the potential role of parental substance abuse in relation to mental health and behavioral outcomes for children in the future. Study limitations include the cross-sectional study design and retrospective methodology as well as the lack of a dimensional measure of current substance abuse.
Funding for this research was provided by the National Institute of Mental Health. (APA 2008; Poster NR3-041). –CP
Risk Factors and Prevalence of Postpartum Depression
Postpartum depression (PPD) is a form of clinical depression that can affect women after childbirth and can even start toward the end of pregnancy. Often undiagnosed or untreated, the prevalence of PPD is estimated to be 12% to 13%. Risk factors include psychosocial variables such as marital dissatisfaction, inadequate social support, and stressful life events. Demographic variables include adolescent pregnancy, unwanted or unplanned pregnancy, and lower socioeconomic status. Psychiatric family and personal history can also prove to be risk factors as well. Early intervention of PPD is ideal as the disorder can negatively affect both mother and infant.
A study by Nesrin Tomruk, MD, and colleagues, at Bakirköy Research and Training Hospital for Psychiatry, Neurology and Neurosurgery in Istanbul, Turkey, examined postpartum patients in the well-baby unit in up to 9 months postpartum period from July–September 2007 and screened for depressive symptoms using the Edinburgh Postnatal Demographic Depression Scale (EPDS). The cut-off point of the 10-item self-rated questionnaire was ≥13; patients with scores ≥13 were labeled as “high risk for depressive disorder.” Demographic and psychosocial variables as well as reproductive, pregnancy, and delivery data were also collected using a separate 51-item semi-structured form.
According to EPDS scores, PPD was found in 30.6% (n=56) of the 183 mothers in the study (mean age=27.52±5.45). High EPDS scores were also significantly correlated with history of premenstrual syndrome and psychiatric treatment as well as the partner’s unemployment, dissatisfaction in marriage, low level of care of the partner, and domestic violence. Also of statistical significance, high EPDS scores were correlated with unplanned pregnancies, nocturnal delivery, health problems during pregnancy in both the mother and fetus, a “difficult baby,” and not nursing.
The study is limited in that the EPDS, when used alone, is not a diagnostic tool for depression. Depression diagnosis should be verified with clinical evaluation as well as other depression scales. However, the EPDS is useful for screening pregnant and postpartum women for early detection and treatment of PPD. (APA 2008; Poster NR 6-120). –DC
HIV Patients with Comorbid Psychiatric Disorders
Previous research has found that patients who are HIV positive (HIV+) have high rates of both substance abuse as well as psychiatric disorders. However, exact prevalence rates have been hard to determine due to patient non-adherence. Rachel A Houchins, MD, and colleagues from the University of South Carolina of Medicine and Palmetto Health Alliance conducted a chart review of 424 HIV+ patients. They collected data regarding age, gender, race, medical conditions, psychiatric diagnoses, substance abuse, income, medications, CD4 count, and viral load of patients seen at the Ryan White Clinic between 2004 and 2006.
Houchins and colleagues found that 41.3% of patients were substance abusers; 35.4% of patients had psychiatric illnesses; 24.9% of patients had a diagnosis of substance abuse; 19% of patients had a psychiatric diagnosis only; and 16.4% of patients had a comorbid diagnosis. However, the rates changed depending on gender and race. They also recorded data regarding patient compliance in terms of medication as well as their ability to keep appointments.
Houchins and colleagues found that a total of 39.7% of patients had no Axis-I diagnosis, 24.9% of all patients had a diagnosis of substance abuse only, 19% had a psychiatric diagnosis only, and 16.4% had comorbidities. When breaking this data down by gender, they found that 72.4% of men were substance abusers only compared to 26.4% of women, while psychiatric diagnosis only was more evenly split (50.6% for men vs 48.2% for women).
When comparing race, 92.5% of blacks were substance abusers only and 70.4% of blacks had a psychiatric diagnosis only Approximately 51% of men had a psychiatric diagnosis only, compared to approximately 48% of women. Comorbidities were more evenly dispersed among gender and ethnicity. They found that 61.4% of men, 38.6% of women, 74.3% of blacks, and 25.7% of whites had comorbidities. Surprisingly, they also found that compliance rates were not statistically different among any of the demographics. In addition, there was no correlation between medical compliance and CD4 counts.
Houchins and colleagues believe that future research should detail the means of engaging the patient in treatment and teach them the means of appropriately participating in their own health care. (APA 2008; Poster NR 1-009). —CN
Threshold Treatment Levels for Functional Improvement in ADHD
Successful long-term outcomes in clinical trials of attention-deficit/hyperactivity disorder (ADHD) treatment have been associated with less severe symptoms at baseline. Conversely, greater symptom severity at baseline can lead to a poorer prognosis. It is less clear, however, to what extent reductions in ADHD symptoms correlate with improved life functioning, as well as what level of treatment is necessary to facilitate functional improvements.
A meta-analysis by Buitelaar and colleagues identified four studies that included a symptomatic measure (ADHD Rating Scale-IV:Parent-Inv [ADHD RS]) and a functional measure (Life Participation Scale [LPS]). The ADHD RS is an 18-item, clinically administered scale that rates the severity of ADHD symptoms with scores ranging from 0–54, with lower scores indicating less symptoms. The LPS, a 24 item scale, measures functional improvements related to treatment with scores from 0–72, with 72 indicating the most improvement.
Subjects, males and females 6–18 years of age at baseline, included those in an atomoxetine group (N=564), methylphenidate (N=220), and placebo (N=256). The mean age of all three groups combined was 10.3 years, and the majority of subjects were diagnosed with ADHD combined type.
Changes in LPS scores over the study’s duration were standardized by calculating the difference between each subject’s change score and the mean of all change LPS scores from all subjects, divided by the standard deviation (SD) of the changes from all subjects. Those with a standardized change of <0.25 SD were defined as indicating no change in functioning, but changes in score >1.0 SD indicated significant functional improvement or worsening. Changes 0.25 SD–1.0 SD indicated a threshold change.
Mean changes in ADHD RS scores were compared with corresponding changes in LPS scores. Buitelaar and colleagues found that a reduction of 16–18 points on the ADHD RS is required for threshold functional improvement, which translates to a 40% to 45% improvement in symptom severity.
A significant improvement in functioning, ie, LPS changes >1.0 SD, requires an ADHD RS score reduction of 20–27 points, which corresponds with 50% to 65% improvement. Overall, an ADHD RS score reduction of at least 20 points is necessary for patients to demonstrate significant improvements in functioning. (APA 2008; Poster NR6-016). –LS
Posters were drawn from the 161st Annual Meeting of the American Psychiatric Association (APA; May 3–8, Washington, DC). Psychiatric dispatches is written by Dena Croog, Michelisa Lanche, Christopher Naccari, Carlos Perkins, Jr, and Lonnie Stoltzfoos.