Report on Clinical Trials: Efficacy of Antipsychotics in Schizophrenia

This report provides an overview of a clinical trial focused on the treatment of schizophrenia using antipsychotic drugs. The study investigates the efficacy of these drugs through randomized control trials (RCTs), highlighting the primary endpoint of symptom reduction. The report details the trial setup, including the use of Paliperidone and cognitive behavior therapy, along with the primary and secondary objectives. The primary objective centers on reducing schizophrenia symptoms using antipsychotic drugs, measured using the PANSS scale. Secondary objectives involve assessing safety parameters and other health-related outcomes. The study design involves a 6-week administration of the drug and regular assessments. The report concludes with a discussion of the importance of RCTs in clinical decision-making, referencing key findings from the study and relevant literature, including the use of the PANSS scale and other clinical measurements.

Running head: CLINICAL TRIAL
Randomized Control Technique
Name of the Student:
Name of the University:
Author Note:

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Introduction
The following article stands to discuss the primary endpoint of the schizophrenic
disorder. The term schizophrenia describe the improper mental state of an individuals which
is usually identified by the concurrent halucinations, discouraged motivation, problems with
interacting, general thinking and regular concentrations. The survey stated that overall 1
percent of the US population suffers from the said disorder.
However, being an uncurable disorder the interventions brought down are the
implementation of certain drugs at the initial stages and theories for maintainance and goal
attainment. In addition, antipsychotics had proven to be efficient enough to bring back the
concerned interventions into implementations to act accordingly (Fellner).
The Randomized control trials have been preffered to perform to understand the
efficacy of these antipsychotic drugs as the primary end point for the schizophrenic disorder
(Stroup, Scott, and Geddes).
Clinical Trial Setup
The production of medications typically conducts feasibility or explanatory trials to
satisfy commercial authorisation criteria for the drug regulatory agencies. These short-term
highly controlled trials associate a new drug with placebo or an active comparative or both,
and typically make no claim about the efficacy of a drug for the longer term. The focus is
health, effectiveness and pace, as businesses pursue a prompt consent for a new medication.
Large simple trials (LSTs) are unique to antipsychotic drugs and neuroscience, but they are
typically used in many other fields of medicine. These trials recruit many patients and
arbitrarily administer therapies in the usual laboratory environments, but use few advanced
methods of evaluation and gather only limited evidence based on crucial results (Stroup,
Scott, and Geddes).

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Prominent LSTs in cardiology, for example in Clopidogrel and Metoprolol trials, used
as key results in the Myocardial Infarction Trial (COMMIT) and Antihypertensive and Lipid
Shrink Therapy to Prevent Heart Attack Trial (ALLHAT). These important research led to
the assessment of the relative gain and severity of hypertension and acute myocardial
infarction therapies. Although relatively new to psychiatry are realistic or pragmatique trials,
some cases have been given additional details on the risks and advantages of psychiatry,
including the current Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE),
the Rapid-tranquilization clinical trial (TREC) and the cost usefulness for latest antipsychotic
drug experiments in schizophrenicity studies. Their sophistication can vary considerably in
functional test design but their overall objective is to provide the specific patients
comparative therapy knowledge, which may be widely applied (Stroup, Scott, and Geddes).
Paliperidone is among one of the recently discovered antipsychotic drugs and can be
put into the certain trial to understand its efficacy in obtaining primary outcomes. While
similarly the practice of cognitive behavior therapy can be implemented on the other hand to
identify the secondary outcome and the outcome in possible risk management.
Primary objective
The disorder termed schizophrenia is non curable and hence the target stays is the
development of efficacy of these affected individuals. The efficacy trial was to reduce and
improve the symptoms of the targeted disorder using the antipsychotic drugs. The trials for
understanding the efficacy of the drug was done using the implementation of the drug that
either it can function under ideal circumstances.The trial run shows that how much efficient
is the drug to work in reduction of the psychotic symptoms. Trained research department
hires patients with an acute psychotic experience and performs expert tests to ensure
symptoms and severe conditions are achieved. In order to minimize the risk of variability to

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effects, certain individuals with a psychological disorder, drug use conditions or other
psychiatric diagnosis are exempt. Treatments are uniformly assigned under double blind
procedures to defend against evaluation and success prejudices so that neither the patient nor
the research team delivering clinical care and performing impact evaluations are aware of the
treatment mission. The treatment cycle of patients is to be monitored for 6-8 weeks by
standard effectiveness tests. Trained personnel regularly perform tests of psychometrically
tested devices on their signs and side effects. The primary outcome is an increase on a
continuum of symptoms such as the Positive and Negative Syndrome Scale (PANSS) is the
main consequence (Stroup, Scott, and Geddes).
Thus the primary objectives stated that implementation of dosage for a course of sic
weeks and study of the rate of increase and decrease in the scale of the syndrome in the
patients.
Secondary objective
As the secondary objectives were the other health related outcomes were considered.
These outcomes were measured based on the rates of responses by the impacted individuals
based on the rate of safety measures. The outcomes were base on the efficacy trials of various
safety parameters and other trials based on the clinical methodologies. A secondary common
result is the reaction or change with a pre-specified sum of a symptom rating scale.
Considered adverse events and specific lab parameters are routinely assessed, whereas if and
when any of the adverse events occured randomly.
Study Design
Based on the process described in an article the study can be designed similarly to
identify the efficacy of the drug of our choice. This can be done by implementing the drug to
the patients in place of those mentioned below.

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The study was conducted by 74 locations of medical facilities in the USA. A total of
444 patients were randomly distributed to one of the 4 treatment arms. Past treatments were
stopped 3 days prior to randomisation including antipsychotics, anti-parkinsonianand beta-
blockers. Paliperidone 6 mg, paliperidone 12 mg, olanzapine 10 mg, or placebo is prescribed
for 6 weeks once everyday. For the first 14 days, the patients were treated and tested during
the experiment at least weekly. Trained raters have measured the efficacy of medications
using a range of metrics including the PANSS scale, CGI, Personal and Social Quality
metric. The study included a number of safety measures, including clinical tests, functional
measurements and cognitive impact rating scales. Randomized patients with at least one
dosage of medication and at least one post-baseline test were mainly evaluated for their
effectiveness. In order to address missing data for the participants who left the study early,
the last finding carried out approach has been used. All patients with at least one dosage of
double-blind treatment were tested for protection (Marder et al.,).
Conclusion
RCTs can be the source of high-quality data for directing various forms of clinical
decision making, with the essential features of randomisation to defend against selection
biases. The article also mentioned several late-stage measures that can be used by clinicians
and other decision-makers in this report. The article did not consider all forms of RCT, which
may focus on the identification of dosage or response pathways and not on efficacy.

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References
Fellner, Chris. “New Schizophrenia Treatments Address Unmet Clinical Needs.” P & T : a
peer-reviewed journal for formulary management vol. 42,2 (2017): 130-134.
Stroup, T Scott, and John R Geddes. “Randomized controlled trials for schizophrenia: study
designs targeted to distinct goals.” Schizophrenia bulletin vol. 34,2 (2008): 266-74.
doi:10.1093/schbul/sbm156
Marder, Stephen R., et al. "Efficacy and safety of paliperidone extended-release tablets:
results of a 6-week, randomized, placebo-controlled study." Biological Psychiatry 62.12
(2007): 1363-1370.