FDA Approves Paliperidone for the Treatment of Schizophrenia
The United States Food and Drug Administration approved paliperidone extended-release tablets (Invega, Janssen) for the treatment of schizophrenia. The recommended daily dose of paliperidone is 6 mg/day, administered in the morning, with a maximum daily dose of 12 mg/day.
Approval was based on three clinical trials of 1,665 adults across 23 countries meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for schizophrenia. Patients received doses of 3, 6, 9, 12, and 15 mg/day. Patients were evaluated using the Positive and Negative Syndrome Scale and the Personal and Social Performance scale. All of the studies found paliperidone to be more effective than placebo after 6 weeks of treatment.
The most common side effects found in ≥5% of patients receiving paliperidone were akathisla (ie, restlessness) and extrapyramidal disorder (eg, involuntary movements, tremors, or muscle stiffness).
For more information, please consult the medication’s full prescribing information. (www.invega.com). —CN
Psychological Treatments Improve Chronic Low Back Pain
Low back pain is substantially disabling and negatively impacts the economy due to decreased work productivity, absenteeism, and increased healthcare utilization. Chronic low back pain is characterized by pain, distress, and disability. The condition may be improved with psychological interventions that focus on relieving depression, enhancing health-related quality of life, and reducing patients’ experience of pain.
Robert Kerns, PhD, at the Veterans Affairs Connecticut Healthcare System in West Haven, and colleagues, evaluated the effects of psychological interventions on pain-related outcomes in an evidence-based review of 22 randomized trials published between 1982 and 2003. A total of 205 effect sizes from these trials were pooled in 34 analyses. Although patients in the trials were adults with nonmalignant low back pain persisting for at least 3 months, the average duration of pain was 7.5 years. The psychological treatments evaluated in the review covered a broad range and included behavioral and cognitive-behavioral techniques; supportive counseling; and self-regulatory techniques (eg, hypnosis, biofeedback, relaxation). Outcomes analyzed included pain intensity, emotional functioning, physical functioning, patient ratings of global improvement, healthcare utilization, healthcare provider visits, pain medications, and employment/disability compensation status.
In contrast to control groups, psychological interventions resulted in positive effects on pain-related outcomes, including pain intensity, pain-related interference, health-related quality of life, and depression. Cognitive-behavioral and self-regulatory treatments, compared to wait-list controls, were the most effective of the treatments analyzed. Reduction in pain intensity was the largest and most consistent effect. Compared to other active treatments, multidisciplinary approaches that included a psychological component were found to reduce pain interference and work-related disability.
Dr. Kerns noted that he and his colleagues were particularly impressed by the evidence that psychological interventions have strong effects in reducing pain severity, in addition to improving functioning and quality of life despite pain.
“When I first started this work 26 years ago, we informed patients that we believed that our interventions might help them ‘learn to live with their pain problem,’” Dr. Kerns said. “Now we have compelling evidence that these same interventions may result in meaningful reductions in pain, per se.”
The researchers believe the study results strongly encourage primary care providers to conduct comprehensive pain assessments that attend to important psychological contributors to the experience of pain, and to consider referral for psychological treatment as a potential valuable component of a integrative treatment plan.
“In the absence of a pain psychologist in the provider’s community, the provider may provide information about the potential benefit of any of several self-help manuals that are currently available that encourage this approach,” Dr. Kerns said.
Regarding study limitations, Kerns and colleagues had to group different measures into common categories such as pain intensity and pain interference, and such efforts likely reduced their ability to demonstrate effects of the interventions. He encouraged more complete reporting of the details of studies in the written published reports to increase the ability to compare and contrast as well as to replicate studies in the future.
Funding for this research was provided by the VA Office of Academic Afilliations postdoctoral psychology fellowship training program. (Health Psychology. In press). —DC
Mental Health Disorder Prevalence Differs for African Americans and Black Caribbeans
According to the United States Department of Health and Human Services, reported rates of mental health disorders for African Americans compared to Caucasian and national populations have been inconsistent. One factor is that few studies have examined differences in mental health disorder rates between African Americans and black Americans of Caribbean ancestry, although studies have shown that Caribbean immigrants differ from African Americans in several physical health measures.
David R. Williams, PhD, of the Department of Society, Human Development and Health at the Harvard School of Public Health in Boston, Massachusetts, and colleagues, examined results from the National Study of American Life, the largest study on the prevalence of mental health disorders among black populations in the US, to determine the prevalence of mental health disorders among black Caribbean and African-American populations as well as the correlating factors of psychiatric conditions for people of Caribbean decent. Conducted by the Program for Research on Black Americans at the University of Michigan’s Institute for Social Research in Ann Arbor, the National Study of American Life surveyed 3,570 African-American men and women, 891 Caucasian men and women of non-Hispanic descent, and 1,621 black Americans of Caribbean descent to assess the physical, emotional, mental, structural, and economic conditions of African-Americans. All participants were ≥18 years of age, non-institutionalized, and interviewed in person with the World Mental Health Composite International Diagnostic Interview. Williams and colleagues assessed prevalence of mental health disorders according to criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and adjusted descriptive and age results.
Among the US black population, 6% is foreign-born and 10% is of foreign ancestry, with people of Caribbean decent comprising the largest subsection of black immigrants (4.4% of the US black population). Williams and colleagues found that men of Caribbean ancestry had 12-month rates of mood and anxiety disorders higher than African-American men. The authors also found that women of Caribbean ancestry had lower current and lifetime 12-month rates of mental health disorders than African-American women.
In addition, Williams and colleagues found generational differences in disorder rates for participants of Caribbean descent. First-generation people of Caribbean descent had lower rates of mental health disorders compared to second- or third-generation black Caribbean participants. Third-generation black Caribbean men and women had the highest rates of mental health disorders among all groups in the study. Risks varied by ethnicity, immigration history, and generation status within the Caribbean study population.
The authors concluded that ethnicity is a key factor for mental health disorder risk in black populations and that clinicians should look beyond broad racial categories and investigate the ethnic background of patients when determining the best treatment options for mental health disorders. The authors added that increased exposure to minority status was associated with higher risks for mental health disorders among Caribbean immigrants.
Funding for this research was provided by the National Institute of Mental Health. (Am J Public Health. 2007;97(1):52-59.) —CP
Mild Substance Misuse Shows no Cognitive Impact on Early Psychosis
Substance use disorders are known to negatively impact cognitive functioning in the general population and often present comorbidly with various psychoses. There is also concern about whether substance use negatively impacts cognition in patients with early psychosis.
A study conducted by Amanda McCleery, BSc, at the Centre for Addiction and Mental Health in Toronto, Canada, and colleagues, assessed 183 patients with first-episode psychosis who had been admitted to the Calgary Early Psychosis Program. The Case Manager Rating Scale for substance use and a comprehensive battery were used to assess the patients at baseline and showed that 49.7% engaged in substance misuse. After 1 year, substance misuse was observed in 27.2% of the 147 patients remaining in the study. At 2 years, 17.2% of 116 patients were misusing substances. Mild substance use showed a different trend, exhibiting in 31.2% of patients at baseline, 46.9% at 1 year, and 52.6% at 2 years. The most frequently used substances were alcohol and cannabis.
Patients in the misuse and mild use groups scored significantly higher in cognitive performance at baseline, which they maintained at 1- and 2-year follow-ups. At both follow-ups, patients who did not use substances at baseline performed more poorly on tasks of verbal memory, verbal fluency, cognitive flexibility, and visuospatial ability. The authors concluded that the substances involved show no evidence of negative impact on cognition in patients with first-episode psychosis.
McCleery noted that the better cognition scored of substance users compared to non-users has been replicated elsewhere in the literature and is hypothesized to be related to fewer negative symptoms and better premorbid social functioning.
“This does not mean that substance use is a not a problem for these patients, as misuse clearly has an impact on several illness factors (eg, positive symptoms),” McCleery said. “Rather, we found no evidence that mild-to-moderate substance use as described here is related to cognitive functioning in this sample.”
McCleery added that the study also reaffirms the assertion that a high comorbidity between substance use and psychosis exists. Moreover, the study demonstrates that substance use can decrease markedly within 1 year in a comprehensive first-episode program.
Among the study’s limitations, duration and quantities of substance use were not assessed in the sample. McCleery noted that this information can be difficult to obtain reliably since it is contingent on retrospective accounts. In addition, assessment of current substance use was based on client report and was not corroborated with biologic measures such as hair samples.
“Another limitation is that it is possible that individuals in this study had not used a sufficient amount of substances for a long enough period of time or even the ‘right’ type of substances for long-term negative effects of substance use on cognition to become manifest,” McCleery said. “Prospective studies which follow individuals prior to the onset of psychosis could help clarify the relationship between cognition and substances in this population.” (Schizophr Res. 2006;88(1-3):187-191.) —DC
Child Abuse Related to Increased Major Depressive Disorder Risk in Young Adults
Child protective service agencies have reported that, in 2002, child maltreatment—including child abuse, neglect, and sexual and emotional abuse—occurred to >900,000 youths in the United States. According to the US Department of Health and Human Services, 61% of these children experienced neglect while 19% were physically abused, 10% were sexually abused, and 5% were emotionally abused.
Previous studies have shown that children who experience one or more of the various forms of maltreatment or abuse are at an increased risk for adverse health effects such as alcoholism and drug abuse, and the development of mental health disorders, including major depressive disorder (MDD), later in life. Although child abuse has been related to MDD in clinical populations and community surveys, there have been few longitudinal studies examining the relationship between abuse or neglect in childhood and depression for victims as young adults.
Cathy Spatz Widom, PhD, of New Jersey Medical School at the University of Medicine and Dentistry of New Jersey in Newark, and colleagues, evaluated 676 children with substantiated cases of physical and sexual abuse and neglect that took place before 11 years of age and 520 non-abused, non-neglected children to determine whether abuse and neglect elevated risk of developing MDD and other comorbid mental health disorders in young adulthood (mean age=28.7 years).
Maltreated children in the study were matched based on age, race, sex, and family social class with non-abused children for study comparison. Cases of abuse took place between 1967 and 1971. Between 1989 and 1995, Widom and colleagues conducted 2-hour, in-person interviews with participants using the National Institute of Mental Health Diagnostic Interview Schedule, Version III Revised, to establish which participants had met Diagnostic and Statistical Manual of Mental Disorders, Third Edition-Revised, criteria for MDD and other mental health disorders.
Widom and colleagues found that child abuse and neglect was associated with a 51% increase in the risk for developing MDD as a young adult when compared to non-abused youths. The children who were predominately physically abused showed a 59% increase in the risk of developing MDD that persisted throughout the participant’s lifetime. Children who experienced various forms of abuse showed a 75% increased risk of lifetime MDD over non-abused children. In addition, the risk of MDD was 59% higher for neglected children. Although childhood sexual abuse was not associated with an elevated risk of MDD, the authors found that children who experienced sexual abuse reported significantly more depressive symptoms later in life than non-sexually abused participants. Other evaluations also showed an earlier onset of MDD for abused and neglected children when compared to non-abused, non-neglected children. Among young adults with MDD, comorbidity was higher for those abused and neglected as children than for non-abused children.
The authors concluded these results show that clinicians should identify and treat MDD at an earlier age for physically abused and neglected children. They added that early intervention may be able to prevent MDD and other mental health disorders from becoming conditions that persist into adulthood and affect other levels of functioning. (Arch Gen Psychiatry. 2007;64(1):49-56.) —CP
Psychiatric Dispatches is written by Dena Croog, Christopher Naccari, and Carlos Perkins, Jr.