Randomized placebo-controlled trial of escitalopram and Venlafaxine XR in the treatment of generalized anxiety disorder. Depression and Anxiety
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II)Literature Evaluation
- A) Study Methods
This research conducted a trial of escitalopram and Venlafaxine XR in curing various anxiety disorders. Patients who qualified and met all the qualification methods during the screening process qualified for the 1-week dingle blind test. The patients that surpassed the placebo pleaded in and advanced and met every qualification mechanism in the baseline visit received random delegation to have two months of double-blind medication of escitalopram (Bose, Korotzer, Gommoll and Li, 2008). Outpatient individuals, both males and females that passed the DSM-IV technique for the general anxiety disease qualified for this research. It was required for patients to score at least 20 on the HAMA tests. Patients were excluded if they qualified for the DSM-IV technique for the basic diagnosis for any particular axis one disorder, which is not among patients who qualified for the DSM-IV requirements for bipolar disorder, personality disorder, mental disorder, or any other cognitive disorder. The exposure control used in this study was a randomized placebo administration. Patients that met the criteria were incorporated into a one week single-blind placebo period. The ones that successfully did the placebo led in and went ahead to meet every qualification received an 8-week double-blind medication using escitalopram, venlafaxine XR or placebo.
Safety tests were carried out in each visit and included the key signs, the body weight as well as the trials of concomitant medication. The basic evaluation was conducted using the Last Observation Carried Forward technique. This is where various comparison measures were shown between every active form of treatment categories, and placebo was performed a double evaluation of covariance approach and the treatment group as well as the study area as factors while the baseline HAMA result as the covariate (Bose, Korotzer, Gommoll and Li, 2008). Secondary efficacy measures included the variation from baseline in the HAMA scale psychic anxiety and the CGI-S scale and CGI-I scale in the end. Extra efficacy measures included the changes in the 8th-week baseline of the Visual Analogue Scale and the Overall Pain Score. The variation from baseline to secondary and extra baseline parameters was assessed using a similar covariance approach elaborated for the basic resultant parameter.
- B) Results
This study had a sample size of 597 participants, of which 4040 were randomized in double-blind medication. Among the 392 who were served with a single dose of the double-blind medicine and were added onto the Safety Group,244(62.2%) of this were females while the rest were males. The mean age of this population was 37.6 years. All except 7 participants got a minimum of a single post-baseline HAMA evaluation and got incorporated in the ITT group. For the safety and ITT samples, there were no available statistically or clinically important imbalances in population parameters. The double-blind medication was done in 104 placebo-treated individuals and 96 venlafaxine XR-treated patients(Bose, Korotzer, Gommoll, and Li, 2008). There was no clear variation between the groups for any particular reason for premature discontinuation. For the basic resultant outcome, the deviation of baseline week eight and Venlafaxine versus placebo was -1.52 and -2.27. Utilizing the OC approach from week eight baseline, the minimum square difference of variation from the baseline at week 8 in the HAMA scale was -1.92 and 3.02, accordingly. The outcomes of active and placebo treatment in each protocol designed efficacy results demonstrated significant seniority to placebo in various techniques or parameters of infection and global results.
c)Critique/Evaluation
For this study, escitalopram did not separate from placebo in the primary evaluation. However, the protocol’s outcomes denied secondary and supplementary assessment, including even the OC technique that analyzes the resultant basic measures showed that the efficacy of escitalopram and Venlafaxine XR(Bose, Korotzer, Gommoll and Li, 2008). One interpretative limitation in this stud is the exclusion of comorbid basic psychiatric conditions, especially depressive disorders that often appear among GAD patients. This makes the sample much more comparable to most of those reported in the initial research. These findings in this study are valid. The confirmation for this is that it was consistent with the initial positive trials of escitalopram. Even with initial assignments and trials, escitalopram is much better sand useful as compared to Venlafaxine. In this study, many Venlafaxine XR-treated individuals stopped as a result of AEs compared to placebo-treated patients.
However, I agree with the author in these studies and results. The consistency of this study with initial trials just stands to prove its validity. I agree with the author’s conclusions which escitalopram is much better tolerated as compared to Venlafaxine. The close similarity of all these trials is that many Venlafaxine XR-treated individuals stopped unexpectedly due to the AEs more than the placebo-treated individuals, which wasn’t even observed among escitalopram related patients. Venlafaxine treated individuals oversaw major changes in mean in their blood pressure during the study compared to the placebo-treated patients while the escitalopram did not. Ventlaffaxinine has been associated before with causing hypertension. The primary analyses as well indicate that the escitalopram significantly did not separate from the placebo. Furthermore, the protocol’s results determined secondary and secondary and primary research. The mean variation from the baseline to the endpoint in the HAMA scale while using the LOCH method while the Venlafaxine one failed.
III. Summary/Conclusion
Generalized anxiety disorder (GAD) is a severe and disturbing condition. The National Institute of Mental Health Epidemiological Catchment Area Project and the National Comorbidity Study indicated that the disorder’s general prevalence rate was over 5%. By defining GAD, its symptoms should temper with the efficient functioning to necessitate the diagnosis(Bose, Korotzer, Gommoll and Li, 2008). The general budget for the treatment of GAD is a smaller cause of the general cost of the community’s condition. Serotonin inhibitors are thought to be the immediate therapy for GAD. Escitalopram is more selective of all available SRIs in the stoppage of serotonin uptake. Placebo-controlled randomized uptake has shown the possible results of escitalopram in avoiding the development of GAD.
Upon administering the drug among participants, there was no bigger difference between the patients who had initially gotten the treatment of GAD. This was represented by 32% for placebo,37% for escitalopram, and 32% for Venlafaxine XR. The same number of individuals in every medication group showed a history of non-responsiveness towards GAD treatment.14 placebo,14 escitalopram, yet nine venlafaxines XR patients had to continue advanced psychiatric complications. The most common were depression and social phobia. In this particular trial, escitalopram did not separate from the placebo based on the primary analysis from the baseline to the endpoint in HAMA complete scale with the LOCF approach while venlafaxine XR did.
Moreover, the protocol findings showed extra analyses, such as the OC technique, to analyze the basic efficacy approach showed that there was a significant result of both esicatolloprma and Venlafaxine XR. These findings generally show a higher level of consistency with the initial tests of escitalopram in GAD medication. However, the confidence levels of active treatment placebo differences kept overlapping. This was no surprise as it was anticipated that the drugs would express the same efficacy in both dosing intervals. In the instance of SDS, Venlafaxine was statistically important, unlike escitalopram. However, it is important to note that this particular trial was never intended for a direct evaluation for both active agents. Thus, there were no strong conclusions drawn about the significant efficacy of these agents.
Reference
Bose, A., Korotzer, A., Gommoll, C. and Li, D., 2008. Randomized placebo-controlled trial of escitalopram and Venlafaxine XR in the treatment of generalized anxiety disorder. Depression and Anxiety, 25(10), pp.854-861.
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