FDA Approves Aripiprazole for the Treatment of Schizophrenia in Adolescents

The United States Food and Drug Administration approved aripiprazole (Abilify, Bristol-Myers Squibb) for the treatment of schizophrenia in adolescents between 13 and 17 years of age.

The recent approval for adolescents was based on a 6-week, double-blind study conducted at 101 centers in 13 countries. It enrolled 302 ethnically diverse pediatric patients who were experiencing an acute episode of schizophrenia and required hospitalization at the time of enrollment. After 3 days without any antipsychotic treatment, patients were randomly assigned to receive either aripiprazole 10 mg/day or 30 mg/day or placebo. The study demonstrated significant improvement with aripiprazole compared to placebo on the primary efficacy endpoint, Positive and Negative Syndrome Scale Total Score.

The recommended oral target dose of aripiprazole for adolescents is 10 mg/day with or without food.

The most common side effects found in ≥5% of pediatric patients receiving aripiprazole were somnolence (ie, drowsiness), tremor, and various extrapyramidal symptoms.

For more information, please consult the medication’s full prescribing information. (www.abilify.com). —ML

 

Psychosocial Intervention Improves Physical and Mental Health of Spouses Who Care for Patients with Alzheimer’s Disease

Patients with Alzheimer’s disease typically present with dementia and other symptoms related to brain damage, such as disorientation and confusion as well as neglect of personal hygiene, safety, and nutrition. Those with Alzheimer’s disease often require specialized care that is commonly provided by spouses and other family members in the home environment. Although such care can be beneficial for patients with Alzheimer’s, those providing that care may be suffering from negative physical and mental health effects and may not seek adequate treatment for their own conditions.

In a recent study, Mary S. Mittelman, DPH, of the Department of Psychiatry of the New York University School of Medicine, and colleagues, sought to determine the effects of counseling and support interventions on the physical health of spouses who acted as caregivers for patients with Alzheimer’s disease. The efficacy of mental health support interventions was evaluated in prior studies by Mittelman and colleagues.

Researchers studied the outcomes from psychosocial interventions or usual care for 406 spouse caregivers of patients with Alzheimer’s over the course of 9.5 years between 1987 and 2006. Interventions included six sessions of individual and family counseling, support group participation, and telephone counseling continuously available to caregivers over a 4-month period. Caregivers in the intervention group were also encouraged to join weekly support groups following the 4-month study period. Usual care included providing caregivers with intervention information and assistance upon request. Structured questionnaires, such as self-reported health measures and number of reported illnesses, were administered at baseline and at regular follow-up periods to assess outcomes.

The authors found that caregivers in the intervention group had significantly better self-reported health than those receiving usual care at the study endpoint (6.87 vs 7.21, in self-reported health measures; mean=7.24). This result was also maintained for 2 years following the study endpoint (6.70 vs 7.01). Mittelman and colleagues found that caregivers began to show improvement in physical health after 4 months of intervention. In addition, positive results due to the interventions remained significant when the authors controlled for nursing home placement, Alzheimer’s disease patient death, caregiver depression symptoms, and caregiver satisfaction with social support.

The authors concluded that counseling and support preserved the self-reported physical health in vulnerable caregivers. They added that interventions may provide more support for caregivers, provide increased education on potential health risks while caring for a spouse, reduce depression symptoms, and help caregivers devote attention to their own health, which may improve caregiver health overall.

Prior studies by the New York University School of Medicine have shown that interventions result in a reduction of depression among caregivers and delayed nursing home placement for spouses with Alzheimer’s disease, when compared to those receiving usual care. The authors believe future studies should focus on psychosocial interventions with biological measures of physical health outcomes. (Am J Geriatr Psychiatry. 2007;15(9):780-789.) —CP

 

Outcome of Relationship-based Child-Parent Counseling to Reduce Abuse

A pilot study, undertaken in inner-city childcare centers in Miami, Florida, measured the effectiveness of several counseling strategies and curricula in reducing child abuse rates in high-risk families with young children. The study concentrated on families with children <5 years of age because, as the authors note, this age group is at the highest risk for abuse.

Ruby Natale, PhD, PsyD, at the Miller School of Medicine, in Miami, and colleagues, assessed the risk of abuse by screening the caretakers or parents of 150 families with the Parenting Stress Index (PSI) and, using a two-tiered approach, enrolled higher risk families in the Tier-2 cohort (n=53); the remaining families were enrolled in the Tier-1 cohort (n=90).

Parents in the Tier-2 cohort completed the PSI and the Adult-Adolescent Parenting Inventory, 2nd edition (AAPI), as pre-post measures. The PSI assesses parental stress levels broadly, but specifically measures stress levels related to the child’s adaptability, acceptability, demandingness, mood, distractibility, hyperactivity, and parent reinforcement. The AAPI assesses the methods of parental discipline as well as the parents’ expectations of their children, whether they use corporal discipline or create oppressive environments for their children.

Families enrolled in Tier-1 management—those at lower risk for abuse—participated in five group-parenting sessions on child brain development and attachment behaviors. Families at higher risk for abuse, Tier-2 families, received 20 individualized parent-child dyadic sessions of responsive training, an intervention designed to target children’s development, specifically highlighting a child’s cognition, communication, social-emotional awareness, and motivation. Another target of the responsive training curriculum is to increase the frequency and quality of parent-children interactions by educating parents and caregivers of the “pivotal developmental behaviors” of their children and how those behaviors contribute to the child’s development.

A demographic profile of this study reveals that 74.1% of the families were headed by the mother, 18.5% by the father, and 3.8% by a maternal guardian; 42.7% of caregivers were aged 26–30 years of age, and 66.7% of the caregivers were African American.

All pre-post measures, tests initially administered at Time 1, were administered again for follow up at Time 2 for both cohorts. Overall, PSI scores improved from Time 1 to Time 2, but only the PSI subscale measuring the attachment relationship to the child was significantly improved; attachment at Time 1 (mean=46.62, SD=29.43) was significantly reduced at Time 2 (mean=38.55, SD=31.20). On the AAPI scale, however, there was a significant improvement in the caregivers’ attitudes toward corporal punishment, eg, caregivers valued alternative disciplinary methods.

With the highly replicable nature of this study, the authors encourage the proliferation of this model to improve maternal response and nurturing in high-risk communities. In addition, by emphasizing alternatives to corporal punishment, the authors report a lower likelihood of abuse from families who undertake similar programs. (US Psychiatry and Mental Health Congress 2007, Poster 127). –LS

 

Divalproex Extended Release and Dialectical-Behavior Therapy Effective in the Treatment of Borderline Personality Disorder

Characterized by instability in personal relationships, chronic feelings of emptiness, impulsivity, and dissociative experiences, borderline personality disorder (BPD) affects 1% to 2% of the United States population, 10% of psychiatric outpatients, and 20% of hospitalized psychiatric patients. Medication—including divalproex extended release (ER) which is commonly used to treat bipolar disorder—has been shown to target three symptom clusters of the disorder, including aggression and impulsivity, mood instability, and psychotic-like symptoms. Treatment with antidepressants, neuroleptics, benzodiazepines, and mood stabilizers may also aid in the efficacy of psychotherapy. Nevertheless, as patients with BPD are more sensitive to and may discontinue treatment because of medication side effects, additional empirical studies aid in researchers understanding of medication treatment response in patients with BPD.

Richelle Moen-Moore, PhD, at the University of Minnesota Medical School in Minneapolis, and colleagues, examined the efficacy of a new formulation of divalproex ER on BPD symptoms in 17 patients. Prior studies have shown that previous formulations of divalproex ER were effective in reducing symptoms of impulsivity and aggression.

Moen-Moore and colleagues utilized a study design beginning with a 4-week “run in” period of condensed dialectical-behavior therapy (DBT) that sought to identify patients as “placebo responders” among patients who responded to psychotherapy early. DBT involves both individual and group counseling focused on training and development of various skills, such as mindfulness, interpersonal effectiveness, emotion regulation, and distress tolerance.

For patients who did not respond early to DBT, other study exclusion criteria included no current or prior history of bipolar disorder, schizophrenia, major depressive disorder (MDD) with psychotic features as well as symptoms of MDD without psychotic features present in the past 12 weeks, and presence of substance abuse, seizure disorder, or pregnancy. All patients who completed the study (n=11) were between 21 and 55 years of age, diagnosed with BPD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and had not taken any mood-stabilizing or psychiatric medications prior to the study beginning.

Blood concentration of divalproex ER was measured at 4, 8, and 16 weeks in order to maintain the medication at a therapeutic range for all patients. In order to determine divalproex ER efficacy, patients were separated into three groups; one group received divalproex ER plus condensed DBT, another group received placebo plus condensed DBT, and the third group received condensed DBT only for 12 weeks.

Moen-Moore and colleagues found that there were no significant differences in treatment response among groups at weeks 4, 8, and 12. However, the authors did find that, for the study period, patients in all three groups improved significantly over time. Examining data from the “run in” phase of the study, Moen-Moore and colleagues found that 12% (two out of 17 patients) improved with condensed DBT alone.

The authors concluded that this finding is unique in that it mirrors actual treatment conditions for most patients whose pharmacotherapy is determined by response to psychotherapy. They added that more studies are needed to increase researchers’ understanding of subcategories of BPD. Study limitations included the small sample size and lack of data validation via the replication of study conditions. (2007 US Psychiatry and Mental Health Congress 2007). —CP

Posters were drawn from the 20th Annual Meeting of the US Psychiatry and Mental Health Congress (October 11–13, 2007, Orlando, Florida). Psychiatric Dispatches is written by Michelisa Lanche, Carlos Perkins, Jr., and Lonnie Stoltzfoos.