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Psy 103-Schizophrenia

Phases of clinical trials in medication development

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Phases of “Clinical Trials” in Medication Development Phase I – conducted in a small group of people (20-80) to assess safety, dosage range, and possible side effects. The primary goal of these trials is to look at the overall safety of a given medication. Phase I studies may last several months. Phase II – further assessment of efficacy and safety in a larger group of people (100-300). Although safety is still a serious consideration, the primary goal of Phase II trials is to determine effectiveness. Phase II studies will last from several months to up to two years. Phase III – testing with approximately 1000-3000 subjects to confirm efficacy, compare with other treatments, monitor safety and side effects. Phase III trials can last from 1-4 years, and are a final consideration of safety, effectiveness, and dosage of a given medication.
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Phase IV – Post-marketing studies to gather further information about safety, efficacy or optimal use. Only 25-30% of candidate medications proceed to Phase III trials, and only 20% are ever marketed. Bringing a new drug to market typically costs $200 million to $800 million, and takes 10-15 years. Other Disorders (Usually with Psychotic Features) In Which Other Disorders (Usually with Psychotic Features) In Which Antipsychotic Medications Are Sometimes Used: Antipsychotic Medications Are Sometimes Used: Major Depression Bipolar Disorder (several antipsychotic medications such as Abilify are FDA-approved for both schizophrenia and bipolar disorder) Paranoid, Schizoid and Schizotypal Personality Disorders Borderline Personality Disorder Post-traumatic Stress Disorder Intense anxiety with psychotic features (e.g., Brief Psychotic Episodes, encephalopathies, etc.) Agitation in the elderly (especially at nightfall: “sundowner’s syndrome”) Prognosis in Schizophrenia Prognosis in Schizophrenia Formerly, “Rule of thirds” 1/3 improve, 1/3 stay same, 1/3 deteriorate – too optimistic rule probably reflects misdiagnosed bipolar disorder Now, outlook is considered more dismal. On 30-year follow-up: 20 % show good adjustment 35 % show fair adjustment 45 % incapacitated Prognosis worse for – symptom schizophrenia New medications may improve prognosis Incidence of schizophrenia appears to be declining world-wide, perhaps due to better infant nutrition and childbirth methods. Could be b/c
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of flu vaccination around the world, preventing maternal infection, cleanliness, suction cup for babies. End End
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