Evaluating a Schizophrenia Research Study

This assignment requires students to critically evaluate a research study focused on schizophrenia. The evaluation focuses on various aspects of the study design and execution, including participant selection, data collection methods, statistical analysis, and reporting of findings. Students need to assess the study's strengths and weaknesses, determine its methodological rigor, and analyze the implications of the results for understanding and treating schizophrenia.

Clozapine for the Treatment-
Resistant Schizophrenic

Table of Contents
Overview:...............................................................................................................................1
Title:.......................................................................................................................................1
Clozapine for the Treatment-Resistant Schizophrenic...................................................................1
Abstract:.................................................................................................................................1
Introduction
................................................................................................................................................1
Methodology...........................................................................................................................2
Patients:..................................................................................................................................3
Treatment:...............................................................................................................................3
Procedures for prevention:.....................................................................................................4
End points:..............................................................................................................................5
Discussion...............................................................................................................................5
APPENDIX .....................................................................................................................................6
REFERENCES................................................................................................................................9

Overview:
Clozapine medicine is an antipsychotic drug which is used by the patients who are
suffering from nervousness, tension, anxiety symptoms, and seizures. The main function of
clozapine is to treat severe schizophrenia. It is a kind of disease which affects the mind of the
patients who are suffering from. This is characterized by the abnormal social behaviour and fails
to recognise what is genuine (Ripke and et. Al., 2014.). There are so many symptoms which
reflects Schizophrenia disease. Some common functions are: false beliefs, unclear or puzzled
thinking, hearing voices which others can hear, limited social engagement and many more.
Schizophrenia creates mental issues and emotional problems for the patients who are infected
with this. For controlling this, Clozapine is used for limiting the role of schizo affective disorder
this may reduce the rate of suicidal behaviour.
Title:
Clozapine for the Treatment-Resistant Schizophrenic
Abstract:
This is segregated into many parts, which are comprised succinctly to render an overview
prior to reading the article in depth. This renders what research is expected to find in terms of
clozapine efficacy. The background and tools are easy to adopt, describing briefly how trial was
convened. In 20th century, there was a famous psychiatrist Kurt Schneider listed the forms of
psychotic symptoms. They covers delusions of being managed by external forces, belief which
viewpoints are being come into or withdrawn from one's conscious mind. The history of
Schizophrenia is complicated and that was not easily be identified by the people and scientists.
But on the basis of the few symptoms, these are identified in an effective manner.
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Introduction
With the emergence of chlorpromazine, various others factors chemical classes and
compounds with antipsychotic action which have been implemented. Despite substantial changes
in the chemical structure, these agents likely to share an ability to bind to dopamine receptors.
When in vitro binding assays are implemented, anti-dopaminergic action and therapeutic potency
are more associated. To more or less degree, these are known as neuroleptics which is connected
with short term extrapyramidal side effects and share long term accountability of prompting
tardive dyskinesia. Despite diverse comparative trails, there are no data which is consistent data
advising that any particular antipsychotic drug which is very effective in treating schizophrenia.
Over the last decade, significant efforts are made for emergence and testing of potential
antipsychotic compounds designated atypical. The main theme of atypicality is a working
concept instead of a well delineated and validated classification. Commonly, this term is applied
to elaborate drugs which emerge to have certain short term extrapyramidal effects in human.
The introduction is short and link up with regards to the issues with the mood of the
patients and urge them to do something wrong like- suicidal behaviour. This is happening due to
the environmental and genetic factors. Environmental issues are covered during adolescence,
diverse infections, parental infections, parental age and nutrition at the time pregnancy. Genetic
issues cover so many varieties. This disease does not apply a cover personality or dissociative
identity disorder conditions with which this is usually confused in the public perception (Ripke
and et. al., 2013).
Methodology
There are two types of methodologies. Which have genetic and environment. However,
there is a strong need to opt certain policies which would help affected patients to overcome
issues associated to these problems. These genetic and environmental issues play a role in the
emergence of schizophrenia. People with a family history of schizophrenia who are having a
transient psychosis have a 20-40% possibilities of being diagnosed after one year.
Genetic: Forecasting of the habitability of Schizophrenia is almost 80% that
demonstrates that 80% of the individual risk to schizophrenia is elaborated by individual
differences in genetics. Such kind of predictions change due to the complication in segregating
genetic and environmental influences. The higher single risk factor for emerging schizophrenia is
is having a first degree connection with the disease; more than 40% of monozygotic twins of
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those with schizophrenia are likewise influenced. If one parent is influenced the risk is about
13% and if both are affected which may increase the risk to almost 50%. there are so many genes
which are recognised to be included in Schizophrenia, every tiny effect and unknown
transmission are covered under this (Lee and et. al., 2012).
Environment: This component linked with emergence of schizophrenia covering the
living environment, drug consumption, and prenatal stressors. Maternal stress is linked up with
an enhance risk of schizophrenia, probably in linked with reelin, maternal distress is observed to
lead to hyper methylation and henceforth under-expression of reelin, which in animal models
leads to limiting in GABAergic neurons, a normal finding in schizophrenia. Maternal nutritional
constraints , like those observed at the time of famine, and also maternal obesity is recognised for
schizophrenia (Bentall, 2013). Both maternal distress and infection is reflected to modify fatal
neuro development via pro-inflammatory proteins.
Parenting style have higher effects, although, people with supportive parents do better
than those along with this critical parents. Childhood trauma, death of a parents, and being
bullied or abused enhanced psychosis risk. Mostly in the urban areas, so many children or adult
have risk of schizophrenia by two factor. Even after implementing drug implementing, ethnic
group, and size group. Other issues which plays a crucial role covering social isolation and
immigration connected to the social adversity, racial discrimination, family dysfunction,
unemployment, and poor housing conditions.
This is hypothesized that in some people, emergence of schizophrenia is connected to
intestinal tract dysfunction like seen with non- celic glutan sensitivity or abnormalities under the
intestinal flora. Schizophrenia is crucial cause of disability, with active psychosis ranked as the
third crucial disabling situation after quadriplegia and dementia and ahead of paraplegia and
blindness.
There are so many drugs or alcohol which are consumed for consumption. Amphetamine,
cocaine and alcohol could emerge in transient stimulant psychosis which demonstrates related to
the schizophrenia. However, this is not usually assumed to be a cause of illness, people with
schizophrenia implement nicotine at more rates than the usual population (Nielsen and et. al.,
2013).
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Patients:
This is the kind of disease which affects person’s ability to think, feel and behave clearly.
However, the root of having this disease does not know, but a combination of genetics,
environment and modification brain chemistry and structure might play a role.
Schizophrenia is known as by thoughts or experiences which seem out of touch with reality,
disorganised behaviour and reduced participants in a daily activity. Under this disease, this is
observed that the patients can control this disease effectively by using the clozapine drug.
After making proper analysis of the case, it has been seen that there is no any
randomisation is done to determine patient reactions. The study was designed to test the
comparative efficacy of clozapine in schizophrenic impatient. All patient those are who met
historical criteria for treatment resistance and the initial severity criteria. It gave their informed
consent those are entered into prospective during of treatment. Improvement under this context
was define as a major aspect as a 20% decline in BPRS sum total score or either post- treatment.
Those people who are entered into the double blind phase of the study were critically
analysed for at least six weeks. The average daily doses of active antipsychotic medication can
retain during double blind treatment. Entire antipsychotic drugs which are used for treating
schizophrenic disease. Before going to begin the study, there is a need to make proper criteria for
supporting advancement of clozapine under this patient’s population were identified. These kind
of layout needed verification of statistical of statistical superiority under whole pre-set area.
Treatment:
In the way to develop and refine selective and indicated prevention efforts for
schizophrenia. According to this specific disorder itself must be soundly analysed. There are
some sorts of risk aspects which are related with schizophrenia such as birth complications and
family history of disorder that is mostly recognised. Enhance immune system activation such as
from inflammation diseases that is carried from older age of the father. It is also said to be right
that population statistics on the heredity of schizophrenia examine that a child with one
diagnosed nurture has around a 10% genetic risk of formulating the disease themselves.
Clozapine is an effective drug which is used to treat schizophrenia disorder in an
effective way. This is the best drug which is used by most of the patients for treating their
disease in an effective manner. However, patients must aware about its dosage, side effects, so
that they can cure or treat their problems effectively. Clozapine is used by the patients who are
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suffering from severe schizophrenia. This is likewise treats to lower the risk of suicidal attempts
in people with schizophrenia and other same types of disorders.
It has been observed that from a long year, some people those are having schizophrenia
recover and don't need any treatment. The person those are having such kind of problems usually
have trouble keeping a job and protective for themselves. They are mostly relying heavily on
their families and friends in order to gain help from them. These kind of diseases can be rarely
misunderstood but it is treatable. In so many critical situation, an individual sustain them to lead
a productive and normal lifestyle.
There is a perfect link among neurotransmitters and schizophrenia. Because, drugs that
are modify the stages of neurotransmitters in individual brain. Most of the researchers
recommend that schizophrenia can be the major caused by an alteration into two parts such as
dopamine and serotonin. There is various effective sign to detect about these diseases like,
depression, social withdrawal, extreme reaction to criticism, inability to cry or express joy or
imbalance laughter or crying (Lee and et. al., 2012). There is not so sure manner to overcome
schizophrenia. Likewise, in early treatment it can help in order to get indication under restriction
before any critical complications arises.
It would be useful to improve the long term outlook. Projected with the ongoing
treatment plan can prevent relapses of schizophrenia evidence. Most of the people with having
such kind of disease are never easy to violent and indeed don't project any unethical attitude.
However, it is a typically starting in early maturity is a chronic brain disorder with
necessary symptoms that would be based on delusion, hallucinations and a lack of moral. There
are presently recognised precursors of schizophrenia that are apparent at the time of immaturity.
A large range of techniques have been formulated that can draw on knowledge of these
precursors in order to determine individuals at risk for the illness and to control the tendency
toward schizophrenia from processing into the full disorder.
A clinical trial was done in order to check the level of efficiency of care and treatment
which was given to the victims of refractory to neuroleptics. Under this method all those patients
whose condition did not get better or unimproved were allotted to clozapine for a fixed duration
of forty-two days. Thereafter distinct criteria were utilized like priori and chlorpromazine to
which patients responded differently. When the health situation of patients treated with distinct
methods was compared than it was realized that all those who were given the treatment with
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clozapine are giving better results as their results were better on the observation scale for
inpatient evaluation.
There are some adverse reactions were analysed by systematic patient feedbacks and their
observation by medical and nursing personnel. For this purpose, continuous clinical laboratory
testing was performed through physical examination.
Procedures for prevention:
The diagnosis of schizophrenia will encompass clinical results that are derived from so
many ethological ways. Hence, it is implausible that any one intervention will be more than
enough to prevent the full syndrome of schizophrenia. The main aims is to reduce the incidence
of a disease. Intervention is associated with primary precaution which can be delivered to generic
population or to various target groups. In most of the situation, schizophrenia can't come totally
of blue. There is necessary modification which needs to develop before the psychotic syndrome.
Fragmentary symptoms, depression, alteration in attitude and non-specific characteristics those
are occur in the weeks, months and a year.
Although there is no proven way to control schizophrenia. Some researchers are looking
for the manners to make it less probable. It is complex illness that is can be partly associated
with people genes. Few events can make drastic changes in the lives of people. Some situations
can sometimes link in families (Ripke and et. al., 2013). It is not essential to having one specific
gene that would be primary cause of these disease. It is a kind of serious mental disorder with a
profound implication on patients and other segments of the societies. It is said to be expensive
disorder to do treatment. Prevention of schizophrenia is categorised into three parts such as:
Primary preventions: It is essentially consisting of various education programmes
regarding the association of obstetric complications and enhance risk of schizophrenia between
people. It is can be overcome in initial stages of occurring. Early prevention treatment helps the
patients in order to overcome these problems in an effective manner. however, this likewise said
that the company needs to adopt these tools that can be used for treating these elements
effectively.
Secondary prevention: It involves certain intervention at proteomic stages. In this phase
literature reviews and discuss evidence associated with the illness of patient. With the quick
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intervention it can help to reduce the morbidity and better quality of life to the client and its
family. The prodromal stage can now be determining because they are based on present
symptoms with having reliability and predictive validity.
Medication: At the initial stage of treatment of schizophrenia is starts with antipsychotic
medications which is often in combination with social and psychological help. It was reducing to
the reduce the positive symptoms of psychosis in 7 to 14 days. Antipsychotic has not able to
provide necessary solution these problems. Most of the people after using these antipsychotic
have side effects. People on typical antipsychotic tends to have more high rate of extrapyramidal
implications. While some atypical are related with weight gain, diabetes and risk of increasing
metabolic syndromes. Those people who are not willing to take medication on a continuous basis
can increase the complications that would be affective for their survival.
End points:
In addition to the me dicative treatment, there are number of psychosocial factors which
are useful for treating schizophrenia covering family therapy, assertive community treatment
supported employment cognitive remediation, psychosocial interventions for substance
implementing and weight management (Ripke and et. Al., 2014). Family therapy or education,
that faces an entire family system of individual, might limit relapses. Evidence for efficiency of
cognitive- behavioral therapy in either limits symptoms or stopping relapse is least.
Discussion
From the above mentioned report, this is observed that Schizophrenia is treated
effectively by using drugs and psychosocial therapy which are used by the patients and their
family members. Clozapine is the best drug ever which are used to treat this disease in an
effective manner. This is not used for psychotic conditions linked to dementia. Clozapine might
cause heart failure, sudden death, pneumonia in the older patients with dementia linked
conditions. Apart from that, there are certain other things which are used by the researcher in
order to draw a valid conclusion.
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APPENDIX
1. Did the study ask a clearly focused question?
Consider if the question is ‘focused’ in terms of: Yes Can’t tell No
– the population studied (YES)
– the intervention given
– the outcomes considered
2. Was this a randomised controlled trial (RCT) and was it appropriately so?
Consider: [Can't tell] Yes Can’t tell No
– why this study was carried out as an RCT []
– if this was the right research approach for the question being asked []
Is it worth continuing?
With the help of this research, researchers would get to know about final conclusion and
on the basis of these he can draw a valid one.
Detailed questions
….....................................................................................................................................................
3. Were participants appropriately allocated to intervention and control groups?
Consider: Yes Can’t tell No
– how participants were allocated to intervention and control groups. Was the process truly
random? [Yes]
– whether the method of allocation was described. Was a method used to balance the
randomisation, e.g. stratification? [Yes]
– how the randomisation schedule was generated and how a participant was allocated to a study
group ? [Can't tell]
– if the groups were well balanced. Are any differences between the groups at entry to the trial
reported? [yes ]
– if there were differences reported that might have explained any outcome(s) (confounding)
[No]
4. Were participants, staff and study personnel ‘blind’ to participants’ study group?
Consider: Yes, Can’t tell , No
– the fact that blinding is not always possible [No]
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– if every effort was made to achieve blinding [It is easy to reach at valid solutions]
– if you think it matters in this study [Yes]
– the fact that we are looking for ‘observer bias’ [Yes]
5. Were all of the participants who entered the trial accounted for at its conclusion?
Consider: Yes Can’t tell No
– if any intervention-group participants got a control-group option or vice versa [It will help to
sustain their life in well organised manner]
– if all participants were followed up in each study group (was there loss-to-follow-up?) [ Yes]
– if all the participants’ outcomes were analysed by the groups to which they were originally
allocated (intention-to-treat analysis) ? [ Can't tell]
– what additional information would you liked to have seen to make you feel better about this
[No]
6. Were the participants in all groups followed up and data collected in the same way?
Consider: Yes Can’t tell No
Yes.
7. Did the study have enough participants to minimise the play of chance?
Consider:
[No.]
8. How are the results presented and what is the main result?
Consider:
– if, for example, the results are presented as a proportion of people experiencing an outcome,
such as risks, or as a measurement, such as mean or median differences, or as survival curves and
hazards
– how large this size of result is and how meaningful it is
– how you would sum up the bottom-line result of the trial in one sentence
9. How precise are these results?
Consider:
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– if the result is precise enough to make a decision
– if a confidence interval were reported. Would your decision about whether or not to use this
intervention be the same at the upper confidence limit as at the lower confidence limit?
– if a p-value is reported where confidence intervals are unavailable
10. Were all important outcomes considered so the results can be applied?
[Yes]
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REFERENCES
Books and Journals:
Ripke, S. and et. Al., 2014. Biological insights from 108 schizophrenia-associated genetic loci.
Nature. 511(7510). p.421.
Ripke, S. and et. al., 2013. Genome-wide association analysis identifies 13 new risk loci for
schizophrenia. Nature genetics. 45(10). p.1150.
Lee, S.H and et. al., 2012. Estimating the proportion of variation in susceptibility to
schizophrenia captured by common SNPs. Nature genetics, 44(3). pp.247-250.
Bentall, R.P. ed., 2013. Reconstructing schizophrenia. Routledge.
Nielsen, J., Correll, C.U., Manu, P. and Kane, J.M., 2013. Termination of clozapine treatment
due to medical reasons: when is it warranted and how can it be avoided?. The Journal of clinical
psychiatry. 74(6). pp.603-13.
Meltzer, H.Y., 2012. Clozapine: balancing safety with superior antipsychotic efficacy. Clinical
schizophrenia & related psychoses. 6(3). pp.134-144.
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