A Comparison of Bipolar I Disorder Randomized Trials, Essay Example

This paper is a comparative analysis of two studies entitled “A Randomized Study of Family-Focused Psychoeducation and Pharmacotherapy in the Outpatient Management of Bipolar Disorder” and “A Randomized, Placebo-Controlled 12-month Trial of Divalproex and Lithium in Treatment of Outpatients with Bipolar I Disorder”. The primary goal of these papers was to examine the effectiveness of psychoeducation and pharmacotherapy on the treatment of Bipolar I Disorder. A secondary goal was to examine whether lithium, or divalproex plus a placebo were effective as prophylactic therapy, which is meant to reduce disease recurrence and morbidity in the population. The reason that this study is important is because bipolar disorder patients have a high risk of relapse. Therefore, examining these treatments will demonstrate whether the recurrence and morbidity of patients with bipolar disorder can be reduced. Also it will indicate whether these treatments can help stabilize patients’ mood.

The method utilized in“Randomized, Placebo-Controlled 12-month Trial of Divalproex and Lithium”is that of a clinical placebo group study thataimed to measure the effectiveness of the drug with bipolar patients that have been diagnosed with recent manic episodes and hospitalization for manic episodes.The hypothesis was that patients that take divalproex will have better results that the drug will more useful than lithium. The intervention utilizedwas a placebo group study with randomization to measure maintenance treatments, manic episodes, and depressive moods. The distinguishing characteristic of this intervention study was performed by investigators, group participants, and included placebo,and randomized controlled trials. The participantsof the study were between the ages of 18-75 years old. There were 372 study participants and over 61% of study participants with at least 1 previous psychiatric hospitalization(Bowden et al., 2000, p. 2). The bipolar study required each participant to be verified by clinical diagnosis. In addition, participants had to meet several criteria for bipolar disease, including a mandatory score based on the index maniac episodes(Bowden et al., 2000, p. 2).Furthermore, the study participants were required to have experienced at least 1 manic episode in the last 3 years in addition to an episode of partial manic or euthymic episodes. The design for this study is a random placebo double blind group study that was meant to compare the usefulness and safety of divalproex sodium with the safety of the placebo and lithium carbonate therapy. Therefore the preliminary phase lasted for 3 months or less followed by a 52 week randomized maintenance phase(Bowden et al., 2000, p. 3). During the unrestricted phase index, manic episodes were treated at the prudence of the scientist. The criteria could be met with or without drug treatment during the first phase. Any other drugs used other than divalproex and lithium were not used when the random testing began(Bowden et al., 2000, p. 3).

The goal of the “Randomized Study of Family-Focused Psychoeducation and Pharmacotherapy”study is to minimize the number of relapses and manic outbreaks by combining psychoeducation and pharmacotherapy treatments(Miklowitz, et al., 2003, p. 2).The null hypothesis of the study was that the combination of psychoeducation and pharmacotherapy in treating bipolar patients would have no significance. Furthermore, the intervention for the study wasdescribed as family-focused therapy, pharmacotherapy, and crisis management intervention.This study had 101 study participants with an average age range from 18-62 years old, which included 64 women and 37 men. The participants were chosen from 698-screened inpatient and outpatients’ patients’ medical records history. This study had a detail 8 eligibility criteria for all participants. In addition, the study design was a face-to-face interview by evaluators covering the last 3 months of their acute bipolar episodes(Miklowitz, et al., 2003, p. 3). The patients were interviewed again at the 3, 6 and 9 months for psychological improvements and 12, 18 and 24 months for post-treatment analysis.

Overall, both articles had similarities because they used pharmacotherapy treatments in their studies along with a similar randomization technique. The differences between the two studies were pharmaceutical based study utilized group therapy and pharmaceutical drugs like Divalproex and lithium as primary observation.Meanwhile, the second study utilized family therapy and patient education to treat the bipolar conditions. Both studies are important because they contribute to some new theories about the effects of pharmaceutical drugs, which gives consumers a better understanding of them. In addition, it helped researchers learn about innovative techniques to treat bipolar conditions with combined pharmaceutical and patient education.The study of the participant’s placebo results indicated that the divalproex was more effective than the placebo and the lithium treatments and the psychoeducation combined with pharmacology treatments was ineffective (Bowden et al., 2000, p. 5).The results indicated that the divalproex drugs were the best treatment. However, the clinical study had some flaws. The study did not include a history of patients with other underlying diseases that could change the results. The best example of this is that individuals that took the lithium had side effects including heart disease, kidney disease, or dehydration.The participants taking divalproex drug concentrated on controlling seizures and depression. The patients taking divalproex should have been excluded from the survey because if they suffered with severe migraines or liver damage, it would skew the results. The randomized, placebo-controlled 12-month trial of Divalproex and lithium should have in-depth eligibility requirements that included examining the patient’s medical history(Bowden et al., 2000, p. 3).This study we would reject the null hypothesis because the patient’s medical history is necessary, which warrants additional studies. The study of psychoeducation combined with pharmacotherapy uncovered that the combined methods did not cause any significant changes to the patient’s bipolar manic conditions(Miklowitz, et al., 2003, p. 6). The results of this study indicate an acceptance of the null hypothesis because it supported the hypothesis by demonstrating 2 years of relevant clinical and therapeutic data.

References

Bowden et al. (2000). A Randomized, Placebo-Controlled 12-month Trial of Divalproex and Lithium in Treatment of Outpatients with Bipolar I Disorder. Arch Gen Psychiatry, 57: 481-489.

Miklowitz et al. (2003). A Randomized Study of Family-Focused Psychoeducation and Pharmacotherapy in the Outpatient Management of Bipolar Disorder. Arch Gen Psychiatry, 60: 904-912.