A Research Program Studying Treatment Effectiveness
and Outcomes in Schizophrenia and Alzheimer’s Disease
| |
A Research Program Studying Treatment Effectiveness |
|
|
|
||
Study Synopsis
|
|||||||||||||||||||||||||||||||||||||||||
| Co-Investigators | Collaborators | ||
|---|---|---|---|
| George Alexopoulos, MD | Barry Lebowitz, PhD | C.E. Davis, PhD | Diana Perkins, MPH, MD |
| Kenneth Davis, MD | Constantine Lyketsos, MD, MHS |
Steven Ferris, PhD | Marvin Swartz, MD |
| Sonia Davis, MD | Bruce Pollock, MD, PhD | John Hsiao, MD | |
| Dilip Jeste, MD | Peter Rabins, MD | Ranga Krishman, MD | |
| Ira Katz, MD | Robert Rosenheck, MD | Jeffrey Lieberman, MD | |
| Richard Keefe, PhD | Gary Small, MD | Mary Mittelman, PhD | |
| Lisa LaVange, PhD | Scott Stroup, MPH,MD | Richard Mohs, PhD | |
The AD trial is a randomized, parallel group, double-blinded study comparing treatment with olanzapine quetiapine, risperidone, and placebo in AD patients with delusions or hallucinations AND/OR clinically significant aggression or agitation. (See schematic design of study.)
Four hundred fifty patients with Alzheimer's disease will be enrolled. Patients who already live in skilled nursing facilities are excluded.
In the initial phase, 100 subjects will be assigned to each of the 3 atypical antipsychotic medications and 150 will be assigned to placebo.
Lasts up to 12 weeks. The acute effects of the treatments will be compared over 12 weeks. A medication change is permitted after 2 weeks if response is sub-optimal. A medication change between weeks 2 and 12 signals entry into phase 2. Subjects who respond well to their first medication enter phase 2 at the end of 12 weeks.
Lasts up to 12 weeks. A medication change is permitted after 2 weeks in phase 2.
Patients whose response to the first treatment is sub-optimal may be switched, double-blindly, to a second treatment. Patients originally on placebo will switch to an atypical or to citalopram. Patients originally on an atypical will switch to another atypical or citalopram.
Patients who have responded well to their first medication may continue on that medication during phase 2.
Lasts until the 36th week of participation. Open label treatment with one of the study medications according to predetermined study algorithm.
Patients who do not respond optimally in phase 2 may be randomly assigned to a previously unused study medication in phase 3.
| Olanzapine 2.5 mg | expected dose range 2.5-10mg/day |
| Quetiapine 25 mg | expected dose range 50-200 mg/day |
| Risperidone 0.5 mg | expected dose range 0.5-2.0 mg/day |
| Citalopram 5 mg | expected dose range 5-30 mg/day |
The primary outcome will be the AD Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC). The ADCS-CGIC is a process for obtaining an assessment of meaningful clinical change over time. The development of the ADCS-CGIC was led by Dr. Schneider in collaboration with the NIA-ADCS. It is a systematic method for assessing clinically significant change in a clinical trial as viewed by an independent skilled and experienced clinician (Schneider et al 1997, Olin and Schneider 1996, Olin et al 1997.) The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. Unlike a targeted symptom scale it takes into account a subject's overall function in the cognitive, behavioral and functional activity domains.
Copyright © 2003 CATIE (Clinical Antipsychotic Trials in Intervention Effectiveness), a study funded by the National Institute of Mental Health and coordinated by the University of North Carolina at Chapel Hill. Please send website comments to CATIE at The UNC School of Medicine Department of Psychiatry