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1 Informed Consent Schizophrenia / Bipolar Studies Patient Consent Only: 98.5% Legal Representative Only:0% Both Patient and Legal Representative1.5% Dementia.

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Presentation on theme: "1 Informed Consent Schizophrenia / Bipolar Studies Patient Consent Only: 98.5% Legal Representative Only:0% Both Patient and Legal Representative1.5% Dementia."— Presentation transcript:

1 1 Informed Consent Schizophrenia / Bipolar Studies Patient Consent Only: 98.5% Legal Representative Only:0% Both Patient and Legal Representative1.5% Dementia Study Patient Consent Only49% Legal Representative Only41% Both Patient and Legal Representative 10% 4614.01

2 2 Efficacy Measures: Schizophrenia Dose Mean Change from Baseline to 2 hours (LOCF) 4058.03 * p<0.05 vs placebo

3 3 Vital Signs: Presence / Absence of Dose- Response Relationship Mean Change from Baseline to 2 hours - Schizophrenia Dose 4408.01 No linear, quadratic, or cubic relationship between the doses (2.5, 5, 7.5, and 10 mg) of Olanzapine

4 4 IMOlz2.5IMOlz5.0IMOlz7.5IMOlz10IMHal7.5IMPla 4034.03 Agitation-Calmness Evaluation Scale: Schizophrenia Dose Scores at 2 hours after first IM injection

5 5 Agitation-Calmness Evaluation Scale 4169.04 1. Marked Agitation 2. Moderate Agitation 3. Mild Agitation 4. Normal 5. Mild Calmness 6. Moderate Calmness 7. Marked Calmness 8. Deep Sleep 9. Unarousable High levels of physical activity; markedly increased levels of verbal expression; may be physically violent; cannot control signs of agitation if requested to do so; may require continuous supervision and / or physical restraint Normal levels of physical activity; normal levels of verbal expression; awake with eyes continuously open Sleeping deeply; cannot be aroused by vigorous verbal or physical stimulation Sleeping lightly; aroused by mild to moderate verbal or physical stimulation; greatly reduced verbal or physical activity

6 6 Dementia Diagnosis Breakdown Dementia Study Dementia Subtype (N=272) Alzheimer's:59.9% (n=163) Vascular: 22.4% (n=61) Mixed: 17.6% (n=48) 4619.01

7 7 Concomitant Medications NOT Allowed: Dementia Study 4434.02 Guanethidine Methyldopa Reserpine Neuroleptics Benzodiazepines Anticonvulsants Antidepressants Lithium Psychostimulants Other Psychotropic Drugs Amantadine Anti-Parkinsonian Drugs Anorexics Antiemetics Cough and Cold Preparations 1 1 With the exception of loratadine (Claritin)


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