Mental Health

A review of agents in late-stage development for the treatment of depression (July 2006).

This central nervous system stimulant delivered via a transdermal patch is the first and only non-oral therapy to receive approval for the treatment of attention deficit/hyperactivity disorder (ADHD).

Selegiline is an irreversible inhibitor of monoamine oxidase (MAO) whose mechanism of action in the treatment of depression is not fully understood.

FDA officials are reviewing an unexpected recommendation from the agency's Drug Safety and Risk Management Advisory Committee to add black box warnings to attention deficit/hyperactivity disorder (ADHD) stimulant medications. In addition to advising the agency about clinical trial designs that could better assess cardiovascular risks associated with ADHD therapies, members of the advisory committee called for immediate action to caution prescribers and patients about potential adverse events associated with these drugs. Concerns about increased risk of myocardial infarction, stroke, and sudden death have emerged with increased prescribing of stimulant ADHD drugs for adults and children?an estimated 4 million patients use these mediations, including more than 1 million adults.

Quetiapine (Seroquel, AstraZeneca), olanzapine (Zyprexa, Lilly), and risperidone (Risperdal, Janssen) are equally effective in patients experiencing first episode psychosis, according to data presented in late October during the Breaking News session at the European College of Neuropsychopharmacology (ECNP) Congress.

A review of antipsychotic agents in late-stage development (August 2005).

SSRI approved for generalized anxiety disorder

Atypical antipsychotic receives bipolar indication

Antipsychotic administered as 1 injection every 2 weeks

Maintenance therapy for schizophrenia

Combination therapy for acute bipolar mania

Antiepileptic approved for long-term maintenance treatment of bipolar disorder

Panic disorder is the most common anxiety disorder in the primary-care setting. It is characterized by episodes of acute, unexpected, and unprovoked anxiety and is often associated with depression and/or agoraphobia. Symptoms may become so pervasive that many life situations may be avoided. Management of panic disorder includes cognitive behavioral therapy, patient education, and pharmacotherapy. This article focuses on the rationale of drug therapy, methods of management, and other clinical considerations such as side effects. In addition, newer formulations are available that may subsequently change how patients are managed. Selective serotonin reuptake inhibitors (SSRIs) are considered first-line therapy, with tricyclic antidepressants (TCAs) as a possible alternative if the patient fails to respond. These agents are also useful in the management of comorbid depression. Benzodiazepines offer more rapid anxiolysis and may be used in combination with an SSRI for bridging. Although monoamine oxidase inhibitors (MAOIs) have been studied, they do not have a significant role in the pharmacological management of panic disorder. (Formulary 2003;38:431?38.)

Alprazolam, which was previously approved for the treatment of anxiety and panic disorder, has now received FDA approval as extended-release tablets for the treatment of panic disorder.

Selective serotonin reuptake inhibitors (SSRIs) experienced increased usage in the 1990s due to their low toxicity and minimal adverse effects. Throughout this period, several clinical reports indicated a link between the use of SSRIs and various bleeding disorders. A recent study published in the Archives of Internal Medicine found a distinct correlation between the use of SSRIs and upper gastrointestinal (GI) tract bleeding. The population-based cohort study was conducted within the 490,000 residents of a northern Denmark county over a five-year period.

Antidepressant now approved for use in pediatric patients

Atomoxetine, a norepinephrine reuptake inhibitor, is the first nonstimulant agent approved for the treatment of ADHD (Strattera, Lilly). It has been approved for use in pediatric and adult patients. Atomoxetine improves ADHD symptom severity versus placebo, as evaluated by the ADHD Rating Scale (ADHD RS), and its efficacy appears comparable to immediate-release methylphenidate. Atomoxetine requires dosage titration and may be administered once or twice daily. Common side effects seen in both pediatric and adult patients include nausea, decreased appetite, and dizziness. Dosage adjustments are necessary for patients receiving atomoxetine and cytochrome P450 2D6 inhibitors. Based on average wholesale price (AWP), atomoxetine is more costly than existing ADHD therapies. Atomoxetine provides an alternative ADHD therapy for patients who may fail or cannot tolerate conventional treatments.

Psychostimulant drugs have consistently demonstrated efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD). Innovative technology has fueled the development of novel release mechanisms and isolation of active enantiomer components with the hopes of enhancing the duration of action and improving the safety and effectiveness. As a result, several new stimulant agents have recently been added to the arsenal of ADHD treatment options. Formulary selection is complicated by the high costs and small but distinct differences among these agents. The five newest FDA-approved stimulant agents for the treatment of ADHD are detailed, and a brief summary of future treatment options, including a recently approved nonstimulant agent, is provided.

Duloxetine is a reuptake inhibitor at serotonergic and noradrenergic neurons and appears to have low affinity for other neurotransmitter systems. In three published clinical trials in patients with MDD, duloxetine was well tolerated and more effective than placebo. Further study is needed to compare its efficacy with that of other antidepressants, to prospectively assess time to onset of antidepressant effect, and to clarify effects on somatic symptoms and potential adverse cardiovascular and sexual effects. Duloxetine is also under investigation for the treatment of stress urinary incontinence in women (trade name to be determined, comarketed by Lilly and Boehringer Ingelheim). Preliminary information suggests that duloxetine therapy reduces the number of incontinence episodes. Duloxetine has been deemed ?approvable? for the treatment of MDD and will be comarketed under the trade name Cymbalta by Eli Lilly and Company and Quintiles.

Studies presented at the Third European Stanley Foundation Conference on Bipolar Disorder in September in Freiburg, Germany, show two newer antipsychotics are each more effective than standard therapy for preventing mania relapse or reducing symptoms.

Aripiprazole is an investigational atypical antipsychotic that received an approvable status from FDA in September 2002 for the treatment of schizophrenia. The decision on approval could be made as early as the end of this year. Aripiprazole offers a unique mechanism of action as a dopamine system stabilizer. Aripiprazole has been found to be effective in both short-term (4?6 wk) and long-term (26?52 wk) treatment trials. It appears to produce less hyperprolactinemia, weight gain, and extrapyramidal symptoms than other antipsychotics.

NME: Single isomer of citalopram approved for treating major depressive disorder

Confusion between two drugs with sound-alike proprietary names, the antipsychotic quetiapine fumarate (Seroquel, AstraZeneca) and antidepressant nefazodone HCl (Serzone, Bristol-Meyers Squibb) has prompted AstraZeneca to send a "Dear Healthcare Professional" letter warning of the potential mix-up.

Anoka Regional Treatment Facility, Anoka, MN-This 150-bed regional treatment facility was spending over half its annual budget on atypical antipsychotic medications. In an effort to better control rising drug class costs, a market share shift analysis of the products currently in use at the facility was conducted.

In this final installment of this series, the authors focus on the use of SSRIs in alcohol dependence, chronic pain, eating disorders, premenstrual dysphoric disorder, and sexual dysfunction. For each condition, the authors examine how well clinical trial evidence supports the application, discuss dosing and safety considerations, and provide their recommendations on preferred and alternative SSRIs, based on the weight of the evidence.

Although selective serotonin reuptake inhibitors (SSRIs) are prescribed most often for depression disorders, they are increasingly being used to treat a variety of other conditions. In this article, the authors assess the evidence on anxiety disorders—generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, and social phobia. For each condition, they present the rationale for SSRI use, the degree of supportive clinical trial evidence, indication-specific dosing and safety considerations, and their recommendations for the preferred and alternative SSRIs.

The American Psychiatric Association has issued updated guidelines for the treatment of patients with bipolar disorder. The guidelines were last updated in 1994.

Atypical antipsychotics withstand strong Geodon debut; Reminyl slices into formulary presence of Alzheimer rivals

New formulations: Single isomer form of methylphenidate for treatment of ADHD

In less than 2 weeks after the launch of generic fluoxetine in August, Merck-Medco had switched 85% of its mail-order Prozac prescriptions to generic versions of the antidepressant. It says its generic switch rate for retail Prozac scripts was 69% over the same time period.