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Part 1. Literature Review and Ethical Considerations
Article One: Treatment outcomes of an acute bipolar depressive episode with psychosis (Marco Antonio Caldieraro MD, PhD1,2, et al., 2018)
The research by Caldieraro et al. was designed to study the impact of psychosis on patients with bipolar disorder (Caldieraro et al., 2018). The researchers conducting the interview also wanted to compare the use of lithium and quetiapine in the psychotic subgroup (Caldieraro et al., 2018). The methodology of finding the participants was designed to keep the inclusion and exclusion to a minimum as the participants had taken part in the Bipolar CHOICE study (Caldieraro et al., 2018). The independent variable in the study was the addition of the medication to the patient, the dependent variable was the observed positive or negative effect on the patient (Caldieraro et al., 2018). The hypothesis of the study was to see if there was a change in the symptoms of those patients with bipolar, and those with bipolar and exhibiting psychotic features at the present moment (Caldieraro et al., 2018). The researchers decided that the study would need to be replicated with a higher number of participants displaying current psychotic features (Caldieraro et al., 2018).
Article Two: Psychopharmacological treatment of psychotic mania and psychotic bipolar depression compared to non-psychotic mania and non-psychotic bipolar depression (Bjørklund et al., 2016. )
The research by Bjorklund et al., 2016 was designed to see if the psychopharmacological treatment of non-psychotic and psychotic episodes of bipolar depression and mania varies in clinical practice (Bjorklund et al., 2016). The researchers conducted a register-based survey that sought out people with their first diagnosis of mania or bipolar depression between the years 2010-2012 (Bjorklund et al., 2016). The independent variable was the psychopharmacological treatment given within the first three months of the diagnosis (Bjorklund et al., 2016). The dependent variable was the variance in treatment at the clinical practice the patient was seen (Bjorklund et al., 2016). The researchers concluded that more studies to see if antipsychotics would be the better choice for the treatment of bipolar depression and mania (Bjorklund et al., 2016).
Article 3: Anti-inflammatory agents in the treatments of bipolar depression: a systematic review and meta-analysis (Rosenblat JD et al., 2016).
The design of the study was which was qualitative and quantitative to see if anti-inflammatory agents play a role in the treatment of bipolar depression (Rosenblat JD et, al., 2016). The data was collected from a variety of online databases and clinical trials (Rosenblat JD et al., 2016). The independent variable was the information collected that used the anti-inflammatory agents and the dependent was the placebo group (Rosenblat JD et al., 2016). The conclusion of the research was that more needed to be done but there was an overall increase of depression in patients that used the anti-inflammatory markers compared with those that used standard therapy as the adjunct.
Article 4: A re-examination of antidepressant treatment-emergent mania in bipolar disorders: evidence of gender differences (Scott J. et al., 2017).
The design of the study was to explore the clinical and prevalent profiles of females and males who develop emergent mania through antidepressant treatment (Scott J. et al., 2017). The research had a random group and a control group that was taken from an original sample of 754 (Scott J. et al., 2017. The research found that 87% of the cases they worked with, which was whittled down to 75, have antidepressant treatment-mania emergent (Scott J.et al. 2017). The study also saw that the cases varied from male to female (Scott J. et al., 2017). There was also a need to examine the history of suicide attempts, alcohol/drug abuse, thyroid, and family history (Scott J. et al., 2017).
Part 2:
For the first study, the researchers had to take into consideration many factors. Particularly Principle B. Fidelity and Responsibility (Nestor and Schutt, p.61, 2015). Principle B. Fidelity and Responsibility states, Psychologists uphold professional standards of conduct, clarify their professional roles and obligations, accept responsibility for their behavior, and seek to manage conflicts of interest that could lead to exploitation or harm (Nestor and Schutt, p.61, 2015). They had to make sure that no subjects would be negatively affected by taking the medication they wanted to study, and if they were, they would need to be taken off the medication immediately.
I believe they did take consideration as the participants had been part of the bipolar CHOICE study. The bipolar CHOICE study was, Bipolar disorder is among the 10 most disabling medical conditions worldwide. While lithium has been used extensively for bipolar disorder since the 1970s, second-generation antipsychotics (SGAs) have supplanted lithium since 1998. To date, no randomized comparative-effectiveness study has compared lithium and any SGA. Method: Within the duration of the study (September 2010-September 2013), participants with bipolar I or II disorder (DSM-IV-TR) were randomized for 6 months to receive lithium (n = 240) or quetiapine (n = 242) (Andrew A. Nierenberg et al., 2019). There is a significant need for more research on bipolar disorder, and I think this study took care to take ethical considerations.
The second study also had to follow similar ethical guidelines. I feel that they took into consideration the subjects, as it was a study to see if the treatment varied in clinical practices. It appears to me that the study would benefit patients, current or the future. On the American Psychological Association website, they made an amendment to Section 8: Research and Publication. The amendment states, 8.14 Sharing Research Data for Verification
(a) After research results are published, psychologists do not withhold the data on which their conclusions are based from other competent professionals who seek to verify the substantive claims through reanalysis and who intend to use such data only for that purpose, provided that the confidentiality of the participants can be protected and unless legal rights concerning proprietary data preclude their release (www.apa.org, 2019). Psychologists are made to share information that is critical and relevant, and I believe this study did just that for the future advancement of the treatment of bipolar.
The third research article had to take into consideration the use of an anti-inflammatory agent, and the use of a placebo (Rosenblat JD et al., 2016). I believe that this falls under Principle C. Integrity which states, Psychologists seek to promote accuracy, honesty, and truthfulness in the science, teaching, and practice of psychology. In these activities, psychologists do not steal, cheat, or engage in fraud, subterfuge, or intentional misrepresentation of fact (Nestor and Schutt, p. 61, 2015).
I could see how, as a researcher, it may be somewhat tempting to want to alter the outcome to be the desired effect of ones hypothesis. The idea behind any research is to potentially increase the success rate of the people affected by the illness or disorder. It needs to be a very ethical team, that conducts studies, to protect the validity of the research and makes sure that all the results are shared truthfully and honestly.
The fourth research article, which I found the most fascinating, had to take serious ethical considerations. Nestor and Schutt share in chapter two that randomness is a process of chance or luck (Nestor and Schutt, p. 11, 2015). The research needs to, use a legal analogy, the burden of the researcher is to prove that the phenomenon under the study is unlikely due to chance (Nestor and Schutt, p. 11, 2015). For Scott J et al the mission of the study was to determine if mania stemmed from the use of an antidepressant (Scott J. et al., 2017). I imagine that is a challenging experiment. The researchers have to monitor the subjects closely in an effort to make sure there are no additional unsettling repercussions.
This study really made me think as if I was a person that experienced a severe manic episode after a change in my medication. I was not part of a research study but the doctor I was seeing at McLean Hospital really seemed to push for this one medication. There was really no need to change the medication I was on, yet he seemed driven by it. When I wound up back in an inpatient unit, the doctors at the hospital got access to my medical records. The doctor had indicated that I was displaying signs of mania and disconnect from reality, but he made no changes in my medication. While reading chapter three something really stood out to me. causality requires the elimination of alternative explanations. In other words, a researcher must show that nothing other than the identified causal variable could be responsible for the observed effect-that is, there is no other plausible explanation for the relationship (Nestor and Schutt, p. 26, 2015). It has become clear to me that the need for ethical review in all cases is critical. I can see how necessary it was in the fourth study, and how I wish it had been taken for me.
Part 3:
For my research proposal, I would like to learn more about the treatments used in bipolar disorder, and the genetic factor of being a female. I have read a lot about bipolar disorder, and the birth of my child brought the disorder to the forefront of my being. Looking back at my life, when I first had my period things began to shift. It was the huge hormonal shift in my body that made things change for me.
In my head, the design of my study would be a random selection of females within the therapeutic practice I use. It is located in Newton MA, so the reach of the geographical location and the ages and ethnicities will be varied. In a perfect world, I would be able to reach a large population of women, to get the best possible outcome for my research.
I want to explore the use of drugs that are used for patients with bipolar, particularly the drugs Depakote and Lamotrigine. Depakote (divalproex sodium) is also used to treat manic episodes associated with bipolar disorder, and migraine headaches (www.rxlist.com, 2019). Lamotrigine Lamictal (lamotrigine) is an anticonvulsant used alone or in combination with other antiseizure medications for treating certain types of seizures (www.rxlist.com, 2019). Both drugs are used in the treatment of bipolar and both have great success or create adverse reactions.
I want to take a survey of what medication is primarily used, and if the positive verse negative results were immediate or took weeks to appear. Asking these questions will require me to be very ethical in my study. I carry biased against one of the medications due to my personal experience with the drug. On the other hand, I am very curious if people had a good or bad experience in their treatment.
One of the main reasons I would want to conduct this study is to narrow down if there is a similar component in women that have an adverse reaction to Lamictal. Is there a similarity that all the women have that makes the drug work against their body chemistry, or is it a completely random case? To me, this seems fascinating.
Principle D. Justice states, Psychologists exercise reasonable judgment and take precautions to ensure that their potential biases, the boundaries of their competence, and the limitations of their expertise do not lead to or condone unjust practices (Nestor and Schutt, p. 61, 2015). I will really need to check my biases walking in, and just gain and study the information required for an informative response. The most important thing would be for me to see if there is a similar genetic trait, similar life stressors, or if it is a completely random effect of the medication.
It really is something I am very curious about and I would love to be part of a research study that gains more information. One of the things that I noticed in reading all the research studies was that there is a clear need for more research on bipolar. I would love to be part of a study that looked at hormonal shifts, childbirth, and any other huge mitigating factors that affect a person with bipolar disorder. I truly believe knowledge is power and I would like to be able to provide more knowledge to the people affected by this disorder.
Reference:
- Bjørklund, L. B., Horsdal, H. T., Mors, O., Gasse, C., & Østergaard, S. D. (2017). Psychopharmacological treatment of psychotic mania and psychotic bipolar depression compared to non-psychotic mania and non-psychotic bipolar depression. Bipolar Disorders,19(6), 505-512. doi:10.1111/bdi.12504
- Caldieraro, M. A., Dufour, S., Sylvia, L. G., Gao, K., Ketter, T. A., Bobo, W. V., . . . Nierenberg, A. A. (2018). Treatment outcomes of the acute bipolar depressive episode with psychosis. Depression and Anxiety,35(5), 402-410. doi:10.1002/da.22716
- Ethical Principles of Psychologists and Code of Conduct. (n.d.). Retrieved June 6, 2019, from https://www.apa.org/ethics/code/
- Friedly, J., Bauer, Z., Comstock, B., Dimango, E., Ferrara, A., Huang, S., . . . Smith-Bindman, R. (2014). Challenges conducting comparative effectiveness research: The Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) experience. Comparative Effectiveness Research,1. doi:10.2147/cer.s59136
- Lamictal vs. Depakote: Differences & Side Effects. (n.d.). Retrieved June 29, 2019, from https://www.rxlist.com/lamictal_vs_depakote/drugs-condition.htm#what_is_lamictal
- Nestor, P., & Schutt, R. K. (2015). Research methods in psychology: Investigating human behavior. Thousand Oaks, CA: SAGE Publications.
- Rosenblat, J. D., Kakar, R., Berk, M., Kessing, L. V., Vinberg, M., Baune, B. T., . . . Mcintyre, R. S. (2016). Anti-inflammatory agents in the treatment of bipolar depression: A systematic review and meta-analysis. Bipolar Disorders,18(2), 89-101. doi:10.1111/bdi.12373
- Scott, J., Brichant-Petitjean, C., Etain, B., Henry, C., Kahn, J., Azorin, J., . . . Bellivier, F. (2017). A re-examination of antidepressant treatment-emergent mania in bipolar disorders: Evidence of gender differences. Acta Psychiatrica Scandinavica,135(5), 479-488. doi:10.1111/acps.12728
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