A 5 page paper that presents a research proposal for testing a hypothetical new drug for bipolar disorder. The introduction is a brief explanation of the study and reason for it. These sections are included: hypotheses, research design, including subjects, criteria for inclusion and procedure. The study is designed as a blind, randomized, placebo controlled study. The analysis section identifies the statistical technique to be used and explains in detail how error is controlled. Bibliography lists 4 sources.
Name of Research Paper File: MM12_PGhypbi.rtf
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Side effects of current drug treatments leave patients feeling "like zombies," "numb," and "without feelings." Further, Zylophene offers a one-drug treatment for this disorder instead of the multi-drug treatments currently
available (Medical News Today, 2004). Bipolar disorder is typically treated lithium or valproate, both of which have been found to be effective for mania and mixed episodes, in combination with
an antipsychotic (Psychopharmacology Update, 2002). Hypotheses: 1. Zylophene will successfully control bipolar disorder. 2. Side-effects of Zylophene will be minimal and limited to temporary feelings of fatigue.
Research Design: This will be a blind, randomized, placebo controlled study. Patients will be randomly assigned to either the experimental group receiving the new drug or the control group
receiving the placebo. Medications will be administered by the research team. Therapists and other staff members will not know which patients are receiving the new drug or the placebo. It
should be noted that this study will first receive permission from the hospital board. The purpose is to assure all procedures are legal and ethical. Furthermore, each patient will in
fact need to agree to participate in the study to be included. Subjects: Fifty patients who are diagnosed with bipolar disorder will participate in this study. Diagnostic
procedures will include DSM-IV multiaxial evaluation, physical examination, psychiatric and medical history, routine laboratory analysis and pregnancy test. Pregnant women will be excluded from the study. The Hamilton depression scale
and the CGI severity of illness scale will be administered (see Nemeroff et al, 2001). Criteria for selection are: * subjects are existing patients at a large psychiatric
hospital. Subjects are in-hospital patients due to severe depression; * patients are newly diagnosed with bipolar disorder; * patients have not previously been prescribed any of the existing pharmaceutical