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Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study

Posted on May 12, 2008 by DementiaGuide

Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study

The CATIE study was Published in the October 12, 2006 issue of the New England Journal of Medicine's paper, Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer's Disease by:
Lon S. Schneider, M.D., Pierre N. Tariot, M.D., Karen S. Dagerman, M.S., Sonia M.Davis, Dr.P.H., John K. Hsiao, M.D., M. Saleem Ismail, M.D., Barry D. Lebowitz, Ph.D., Constantine G. Lyketsos, M.D., M.H.S., J. Michael Ryan, M.D., T. Scott Stroup, M.D., David L. Sultzer, M.D., Daniel Weintraub, M.D., Jeffrey A. Lieberman, M.D., for the CATIE-AD Study Group



Background Second-generation (atypical) antipsychotic drugs are widely used to treat psychosis, aggression, and agitation in patients with Alzheimer's disease, but their benefits are uncertain and concerns about safety have emerged. We assessed the effectiveness of atypical antipsychotic drugs in outpatients with Alzheimer's disease. Methods In this 42-site, double-blind, placebo-controlled trial, 421 outpatients with Alzheimer's disease and psychosis, aggression, or agitation were randomly assigned to receive olanzapine (mean dose, 5.5 mg per day), quetiapine (mean dose, 56.5 mg per day), risperidone (mean dose, 1.0 mg per day), or placebo. Doses were adjusted as needed, and patients were followed for up to 36 weeks. The main outcomes were the time from initial treatment to the discontinuation of treatment for any reason and the number of patients with at least minimal improvement on the Clinical Global Impression of Change (CGIC) scale at 12 weeks. Results There were no significant differences among treatments with regard to the time to the discontinuation of treatment for any reason: olanzapine (median, 8.1 weeks), quetiapine (median, 5.3 weeks), risperidone (median, 7.4 weeks), and placebo (median, 8.0 weeks) (P=0.52). The median time to the discontinuation of treatment due to a lack of efficacy favored olanzapine (22.1 weeks) and risperidone (26.7 weeks) as compared with quetiapine (9.1 weeks) and placebo (9.0 weeks) (P=0.002). The time to the discontinuation of treatment due to adverse events or intolerability favored placebo. Overall, 24% of patients who received olanzapine, 16% of patients who received quetiapine, 18% of patients who received risperidone, and 5% of patients who received placebo discontinued their assigned treatment owing to intolerability (P=0.009). No significant differences were noted among the groups with regard to improvement on the CGIC scale. Improvement was observed in 32% of patients assigned to olanzapine, 26% of patients assigned to quetiapine, 29% of patients assigned to risperidone, and 21% of patients assigned to placebo (P=0.22). Conclusions Adverse effects offset advantages in the efficacy of atypical antipsychotic drugs for the treatment of psychosis, aggression, or agitation in patients with Alzheimer's disease.


From the National Institute of Mental Health:

NIMH Perspective on Treating Alzheimer's Patients with Antipsychotic Medications

The recent publication of phase 1 results from the NIMH-funded Clinical Antipsychotic Trials in Intervention Effectiveness for Alzheimer's disease (CATIE-AD) in the New England Journal of Medicine provides new information about the use of several "atypical" antipsychotic medications for the treatment of psychotic symptoms in patients with Alzheimer's disease.Approximately 75 percent of Alzheimer's patients experience psychotic symptoms such as hallucinations, and behavioral symptoms such as aggression and agitation.1 The U.S. Food and Drug Administration has not approved the use of antipsychotic medications for treating psychosis or agitation among Alzheimer's patients, citing safety concerns. In the absence of a better pharmacological alternative, however, antipsychotic medications are widely used on an off-label basis. In fact, it is estimated that 25 percent of Medicare beneficiaries in nursing homes receive these medications.2

The extent to which these medications benefit patients is unclear, and opinions vary as to whether they are safe for this population. The results of phase 1 of CATIE-AD provide a first set of real-world effectiveness data where little existed before. Overall, data from this trial suggest:

Although some atypical antipsychotic medications are modestly helpful for some patients, they are not effective for the majority of Alzheimer's patients with psychotic symptoms.
Good clinical practice requires that medical or environmental causes for Alzheimer's-related agitation and aggression be ruled out and that behavioral interventions be considered before turning to antipsychotic medications.
If an antipsychotic medication then is warranted, clinicians should closely monitor their Alzheimer's patients for intolerable side effects and potential safety concerns.
Clinicians should be mindful of the limitations of these medications and weigh the risks against potential benefits.

Clinical research data indicate that other medications - such as antidepressants, anxiety medications, sedatives, and mood stabilizers - that are commonly used to manage psychotic symptoms in Alzheimer's patients, also have significant limitations and risks. Therefore, developing policy that could severely limit physician and patient use of atypical antipsychotic medications would not be in the best interest of these patients. More research is needed to identify the subset of patients who will most likely benefit from and tolerate these medications, and to develop better treatments for this vulnerable population.

1. Devanand DP, Jacobs DM, Tang MX, et al. The course of psychopathologic features in mild to moderate Alzheimer disease. Archives of General Psychiatry 1997;54:257-63.

2. The Quality of Antipsychotic Drug Prescribing in Nursing Homes, Becky A. Briesacher; M. Rhona Limcangco; Linda Simoni-Wastila; Jalpa A. Doshi; Suzi R. Levens; Dennis G. Shea; Bruce Stuart, Arch Intern Med. 2005;165:1280-12.

From the National Institute of Mental Health:

American Association for Geriatric Psychiatry's 2007 conference agenda
March 2, 2007 - 12:00 n - 2:00 pm
Atypical Antipsychotics in Alzheimer's Disease: Results of the NIMH CATIE-AD Trial

Supported by an education grant from Forest Research Institute, a division of Forest Laboratories, Inc.

Chair: Lon S. Schneider, M.D., M.S.
Faculty: Lon S. Schneider, M.D., M.S.
Pierre N. Tariot, M.D.
David Sultzer, M.D.
Constantine G. Lyketsos, M.D., M.H.S.

Antipsychotics are the most commonly used class of drugs for treating delusions and aggression associated with Alzheimer's disease (AD). This session will discuss the complete results of the NIMH CATIE-AD trial, which was a placebo-controlled trial of three atypical antipsychotics. Patients were followed for nine months to assess overall effectiveness. Those patients not responding to the first randomly assigned medication could be re-randomized to the other antipsychotics or to citalopram. Arch Intern Med. 2005;165:1280-12.

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