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Background

Question:

Write an essay on the antipsychotic drug.

The paper discusses about the antipsychotic drug Clozapine and its side effect on body. The main issue with Clozapine in patient suffering from mental disease like Schizophrenia is the weight gain and increased appetite. The paper brings up the weight gain side effect of Clozapine. The participants of the stud were 753 hospitalized patients. The participants were the ones whose sample shows DSM-IV diagnosis of schizophrenia. The age of the participants was from 18 to 65 years. The participants who took at least 300mg of Clozapine daily for at least one year and having a BMI of more than 27 kg/m 2.  The participants were excluded  if they were taking any other antipsychotic drug apart from Clozapine, taking any lipid-lowering drugs,  have abnormal body functioning, multiple organ failure, mental retardation, acute mental illness, pregnant, lactating, can’t walk, and not interested in the study (Aronne, 2001). After the exclusion criteria only 56 patients were selected for the study. The study was carried out after the approval from the Yu-Li Veterans Hospital's Ethics Review Committee. The participants were informed about the study and a written consent was taken from them.

The intervention included controlling the diet of the participants carried out by a registered dietician. The calorie intake for women was between 1,300 to 1,500 kcal and for men between 1,600 to 1,800 kcal per day. The calorie intake with the type of food was assessed. The diet includes fruits, vegetables, sugar free juice. The diet was in accordance to consume the required percentage of protein, fat, and carbohydrate. The study also included physical activity for the patients (Ito et al., 2003). The physical activity was sustained for 6 months and participants performed 3 days in a week (Lamberti, Bellnier, & Schwarzkopf, 1992). The physical activity included exercising, walking for 1.62 km for 40 minutes, climbing 231 stairs and climbing down 330 stairs under full supervision. The level of exercise was kept constant for first six months and participants were encouraged to perform physical activity for about 60 minuted. The patients were expending energy of about 600-750kCal per week. The participants were motivated by giving small rewards.

The study design included measuring various vital areas and weight of the body during different timings. Twenty five people were assigned to the control group and twenty eight people were assigned to the study group The Anthropometric and body parameters were carried after fasting (Allison, Mackell, & McDonnell, 2003). Body weight, body fat, height, waist and hip circumference, and BMI were calculated. Additionally overnight fasting blood samples were also taken. Part of the sample taken was used for metabolic analysis and enzyme assay and the other part of the sample was taken to perform an enzyme-linked immunosorbent assay (ELISA) analysis. So, as to check the effectiveness of the study statistical analysis was done using variance and covariance analysis (ANCOVA) with SPSS statistical software (version 10.0) and was based on a general linear model. All the data of the study group was compared to the control group at the start of the study and again after 3 to six months (Opgaard & Wang, 2005). The result shows that there was not much difference at the baseline between the control group and study group regarding the BMI, body weight, waist and hip circumference, waist-to-hip ratio, and fat percentage of body weight. However, significant difference was seen after three months and six months in BMI, body weight, and waist and hip circumference measures; although the body fat percentage showed little difference. The metabolic analysis included analysing the serum glucose, triglyceride, cholesterol, prolactin, cortisol, and insulin levels. At base line no difference was seen in between the study and the control group. After six month the triglyceride level was significantly lowered but no difference was found in glucose, cholesterol, prolactin, cortisol, and insulin levels. No significant difference were found between the contro and the study group at the baseline and after six months for the growth hormone and IGF-1.  IGFBP-3 concentration reduce after three and six months intervention and the molar ratio of IGF-1 and IGFBP-3 was significantly increased at three and six months intervention.

Methods

The main findings suggested dietary control and physical activity inclusion was good for the patient’s health. After six months from the intervention the patient’s metabolic abnormalities were decreased, hormonal changes were reduced, and even the neuroleptic related side effects were also attenuated. Thus, the findings suggest Clozapine was responsible for the increase of the patient’s weight (Wu et al., 2007). The patient who are obese and as well as the patient who are in the normal range and are if consuming Clozapine must undergo a proper diet regimen and some sort of physical activity or exercise. Life style modifications were the easiest and perfect intervention for the Schizophrenia patients to enjoy the healthy benefits of life and to remain free from other diseases.

The study focuses on lifestyle interventions which majorly included diet change and physical activity exercises. The intervention and outcome are strongly related. The lifestyle modification was the only thing that brought up a good, effective and healthy result. Earlier before the interventions the participants were not carrying out the same routine without putting much effort to improve their health. The only form of improvement was the dependence on medical treatments. However, after the interventions the patient’s body started changing. The outcomes were seen in their BMI’s, body weight’s, hip and waist circumferences, triglyceride levels, and in growth hormones. Due to the strong relation between the exposure and outcome the patient’s body was moving to a health being, the risk of other diseases were reducing, and even the patient’s were feeling satisfied. If the exposure was not taken out seriously and regularly the health outcomes would not be seen (Kuo et al, 2013). Although, the exposure took at least three to six months time to get the desired outcome but, with time the exposure greatly affected the patient’s health and helped in getting a healthy result. Moving on, it can be seen there was a dose response relationship between the exposure and the outcome and was also related to time and consistency. The diet and physical activity were the doses that resulted in the outcome.  The dose of food and exercise were related to the outcome. With time and pace as the dose was increasing the body was shifting towards more effective outcome (Saha et al., 2007). The interventions were seen to be more effective with time due to the fact that the dose that is the physical activity were also increased with time after three months. All the interventions were consistent with the outcome. The participants carried out little physical activity and food change habits so the outcomes were fairly balanced. As the intervention was not carried out at a fast pace so, the results were also not drastically changed but they were fairly going on with the pace of interventions. The outcomes showed significant differences of around 5% in the first three months and around 10-15% after 6 months. This completely suggests that the outcomes were significant and consistent (Ali, Cohen & Lee, 2003). The body takes time to adapt to new changes and the outcomes can also be seem after a time period is passed with regular interventions. Same thing was happening in the case study the control group and the study group outcomes were consistent enough as per the intervention.

The association between the exposure and the outcome is strong but, there are some points that are non-casual.  Like with decrease in all the body variables the fat percentage didn’t changed significantly. Same way the glucose, cholesterol, prolactin, and cortisol concentration didn’t changed significantly. The reasons behind these changes are not known clearly. It depends on the body nature to find an accurate casual relationship was difficult for the outcomes.  The participants were selected by a set criterion that can be a reason for biased results. All the participants who were almost or inclined towards a fit life were selected. Any of them who had even a slight misbalanced health were not included. This may be a reason that the outcome was biased and consistent with the intervention. Secondly the body measurements were taken for hip and waist there was no measurements that were taken for other body parts. The exercises focused were walking and climbing stairs that focussed mainly on lower body. The lower body exercises will affect the hip and waist area more. Thus, it can be seen the measurement were taken in a biased way including only the lower body.

The cofounding variable in the study were the medical drug Clozapine. The participants who took at least 300mg of the Clozapine were only added in the study (McKibbin et al., 2006). As the study, was only to find out the effect of Clozapine on weight gain it can be seen the confound variable did not effects the outcome. It was only due to the confounding variable it was seen how far does Clozapine is related to increase in the body weight.  The chances that variation may occur in the study during the intervention or the outcome are every less. The intervention was focussed on diet and physical activity that was carried out under strict supervision. The chances that an variation must have occurred and has affected the results are very less as the study was carried out for the in patients and everything was done in the hospital itself (Khosravi, Diamandi, & Mistry, 1995). The chance variation that may have occurred would be the denial by the participants to eat in the restricted amount or to carry out physical activity at all times when asked. The participants may have denied the intervention for some time but, it would not have affected the outcomes to a larger extent. Only little amount of affect would have happened to the outcomes due to such chance variations.

Results

Many other studies are been performed to relate Clozapine and weigh gain. A study was performed by Cecilia and his colleagues which was a 6-month randomized controlled trial to test the efficacy of a lifestyle intervention for weight gain management in schizophrenia (Littrell et al., 2003). A multicentric randomized clinical trial with a lifestyle intervention for individuals with schizophrenia, where the intervention group maintained weight and presented a tendency to decrease weight after 6 months. The result suggested that lifestyle intervention is important and is a long term strategy to avoid tendency of the individuals to gain weight. In the study it was seen the weight was decreasing and the health outcomes of the patients with Schizophrenia were increasing when they carried out the lifestyle intervention continuously for a long time. The studies suggest that Schizophrenia patients have a tendency to gain weight due to antipsychotic drugs. The findings are consistent with other studies which clearly suggest lifestyle intervention is beneficial for the Schizophrenia patient. All other findings also suggest the same intervention for Schizophrenia patient that includes healthy diet and some amount of physical activity (Goldsman, 1999). The other designs go on well with the designs and also with the findings and suggest that Schizophrenia effect and antipsychotic drugs effects can be reduced and the health outcomes can be improved.The results are very much plausible according to the biological mechanism of the body. Its body to reduce the extra fat and muscles with help of physical activities and proper diet. Diet which contains fruits and vegetable and less calorie foods helps in boosting the metabolism and reducing weight. The diet proposed in the study was aimed at the same type of food that works to increase body’ metabolism and go on with the mechanism of body (Bushe et al., 2005). On the other hand, physical activities tone up the body muscles and reduce extra fat present in the body. It also strengthens the body and increase the metabolic rate (Roe et al, 1994). So the lifestyle intervention and the results of the study go on with the biological mechanism of the body. It’s the body mechanism to reduce weight by burning of the extra calories and eating healthy food with fewer calories. 

The findings that came out are valid for every individual who is suffering from Schizophrenia and taking Clozapine. The intervention process can be generalised to any of the individual. The intervention didn’t include any medical process or medical drug. The intervention was a life style modification so in case the other individual carried out the intervention no harm would be done to their health In fact, their health outcomes would be improved. Although, the intervention requires a supervision. The findings are externally valid and generalisable and they can be applied to the source population from which the study population was derived. In case, the source population also carried out the same intervention as carried out to by the study population they outcomes would be seen (Daumit, Goldberg, & Anthony, 2005). Even 5% to 10% of reduction in body weight shows health benefit. The source population can be the people who are having Schizophrenia and taking Clozapine or taking other drugs also along with Clozapine. The intervention not only works in case of the individuals who take Clozapine instead it can work for any population who has become obese or gained weight. Yes, the study result can be applied to other relevant population as it was only a life style change with no change in the medical drugs and medical process. The relevant population that have Schizophrenia and take Clozapine is also prone to gain weight with time due to the drug. So, the same intervention and findings can be applied to them (Heimberg et al., 1995). The study design was made to check whether the Schizophrenia patient could reduce weight when a proper lifestyle intervention is applied to them for a period of six months. Thus, it can be seen the study findings can be held in generalized way for the source population and as well as other relevant population. However, the study was carried out for a short period of six months so, the findings were not drastically significant for the study population and even if applied for the relevant population.

References

Ali, O., Cohen, P., & Lee, K.W. (2003). Epidemiology and biology of insulin-like growth factor binding protein-3 (IGFBP-3) as an anti-cancer molecule. Hormone and Metabolic Research 35:726–733.

Allison, D.B., Mackell, J.A., & McDonnell, D.D. (2003). The impact of weight gain on quality of life among persons with schizophrenia. Psychiatr Serv. 54: 565-567. 

Aronne, L.J.(2001). Epidemiology, morbidity, and treatment of overweight and obesity. Journal of Clinical Psychiatry 62(suppl 23):13–22.

Bushe, C., Haddad, P., Peveler, R., Pendlebury, J. (2005). The role of lifestyle interventions and weight management in schizophrenia. J Psychopharmacol. 19: 28-35.

Daumit, G.L., Goldberg, R.W., & Anthony, C. et al (2005). Physical activity patterns in adults with severe mental illness. Journal of Nervous and Mental Disease 193:641–646, 2005

Faulkner, G., Cohn, T., & Remington, G. (2009). Interventions to reduce weight gain in schizophrenia. The Cochrane Library.

Goldman. LS. (1999). Medical illness in patients with schizophrenia. Journal of Clinical Psychiatry 60(suppl 21):10–15.

Heimberg, C, Gallacher, F, Gur RC, et al (1995). Diet and gender moderate clozapine-related weight gain. Human Psychopharmacology: Clinical and Experimental 10:367–375,

Ito, H., Nakasuga, K., Ohshima, A., et al (2003). Detection of cardiovascular risk factors by indices of obesity obtained from anthropometry and dual-energy X-ray absorptiometry in Japanese individuals. International Journal of Obesity and Related Metabolic Disorders 27:232–237, 2003

Khosravi, M.J., Diamandi, A., & Mistry, J. (1995). An ultrasensitive immunoassay for prostate-specific antigen based on conventional colorimetric detection. Clinical Biochemistry 28:407–414.

Lamberti, JS, Bellnier, T, & Schwarzkopf, S.B. (1992). Weight gain among schizophrenic patients treated with clozapine. American Journal of Psychiatry 149:689–690.

Littrell, K.H., Hilligoss, N.M., Kirshner, .C.D.,  Petty, R.G., & Johnson, C.G. (2003). The effects of an educational intervention on antipsychotic-induced weight gain. J Nurs Scholarsh., 35: 237-241.

Kuo, F., Lee, C.H., Hsieh, C.H., Kuo, P., Chen, Y.C., & Hung, Y.J. (2013). Lifestyle modification and behavior therapy effectively reduce body weight and increase serum level of brain-derived neurotrophic factor in obese non-diabetic patients with schizophrenia. Psychiatry Res. 2009:150–4.

McKibbin, C.L., Patterson, T.L., Norman, G., Patrick, K., Jin, H., & Roesch, S. (2006).  A lifestyle intervention for older schizophrenia patients with diabetes mellitus: A randomized controlled trial. Schizophr Res. 86: 36-44.

Opgaard, O.S. & Wang, P.H. (2005). IGF-I is a matter of heart. Growth Hormone and IGF Research 15:89–94.

Roe, L, Strong, C., Whiteside, C., Neil, A., & Mant, D. (1994). Dietary intervention in primary care: validity of the DINE method for Diet Assessment. Fam Pract. 11: 375-381.

Saha, S, Chant D, McGrath J. (2007). A systematic review of mortality in schizophreniais the differential mortality gap worsening over time?. Arch Gen Psychiatry. 64

Wu, M.K., Wang, C.K., Bai, Y.M., Huang, C.Y., & Lee, S.D. (2007).  Outcomes of obese, clozapine-treated inpatients with schizophrenia placed on a six-month diet and physical activity program. Psychiatr Serv. 58: 544-550.
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