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A total of 37 subjects were enrolled in the study, which was a randomized, double-blind, placebo-controlled, crossover trial involving 12 men. The dose was chosen to provide a dose of 17.5 mg per day that was equivalent to our previous dose of 20 mg per day nefazodone in a sample of 27 patients with acute major depressive disorder. The dosing schedule of nefazodone and fluoxetine was well described in the previous publication (Hodges 2009). study was registered at clinicaltrials.gov as NCT01747692. A description of the study design is available in the Supplemental Appendix (available with full text of this letter at NEJM.org).
Two active and placebo groups were administered with separate study periods (n = 22 patients). The study was conducted over 2 periods, a 1-year placebo period (intervention period) and then a 2-year active period and placebo (washout period). Each period included a washout from baseline to washout. On day 0 at each treatment period, all patients were evaluated for psychotic symptoms. At approximately one-third to one-half of the study period, patients were randomly assigned to receive 4 mg/day fluoxetine or a matching placebo. All patients were monitored for psychotic symptoms at all follow-up visits. When patients in the placebo group discontinued a treatment or were unable to continue the study treatment, they were immediately switched to the fluoxetine group.
Baseline characteristics of the patients were obtained at baseline and Propecia order canada the end of active treatments. Baseline characteristics included demographic, clinical, and laboratory data, as described elsewhere (Hodges 2009).
Psychotic symptoms were assessed at baseline and the end of first last open-label treatment period (intervention period). Thereafter, patients were monitored for psychotic symptoms at biweekly follow-up assessments throughout the 2-year treatment period. At each follow-up visit, patients received diagnostic assessments (serum drug levels) and standardized diagnostic assessments (QIDS-SR10 IELTS). At the end of 2-year active treatment period, subjects were reassessed for the presence of psychotic symptoms in conjunction with QIDS-SR10 and IELTS criteria. In order to evaluate the effectiveness of fluoxetine arm compared with the placebo for presence of psychotic symptoms, we performed an open-label, double-blind, placebo-controlled trial using the structured clinician-rated version of SCID-I (Beck et Venlafaxine 10 Pills 100mg $59 - $5.9 Per pill al. 1990). The treatment periods for open-label, double-blind, placebo-controlled study were the 2-year active treatment period and the 2-year placebo period.
Patients in the active drug and placebo treatment groups completed clinical evaluations using the Hamilton Rating Scale for Depression â€“ Research 19-Item Version and the Hamilton Depression Rating Scale, Research 17-Item Version. The Hamilton Rating Scale for Depression is a 20-item scale that used to assess the severity and functional status of subjects with major depression (Lopez et al. 1990). The Hamilton Depression Rating Scale, Research 17-Item Version is the 9-item clinician-rated of Hamilton Rating Scale for Depression with a 5-item point cut-off for score that is sufficient to indicate clinical depression (Lopez et al. 1990). The patients rated depressive symptoms as follows: "Do you experience more than moderately depressed mood most of the time?" "How often do you have feelings of sadness?" and "How often do you feel hopeless or depressed?" The Hamilton Rating Scale for Depressionâ€“Research is a 20-item scale that includes 15 items assessing both depressed mood and cognitive performance, 5 items assessing the presence of fatigue or physical symptoms (Saunders 2003). The Hamilton Depression Rating Scale, Research 17-Item Version is a 9-item clinician-rated of the baseline version Hamilton Rating Scale for Depression with a 5-item point cut-off that indicates depression for the presence of and fatigue for impairment function (Saunders 2003).
At the study's completion, patient-reported mean Hamilton Rating Scale for Depression â€“ Research score was 2 points higher in the treatment venlafaxine hcl er 37.5 mg groups than placebo group. The mean HAM-D scores in active drug arm were higher by 9.4 points (P < 0.001). The mean HAM-D scores were 8 points higher in the placebo arm (P = 0.04) and at the follow-up visit (P = 0.01). The mean change from baseline to follow-up was -14.5 HAM-D points (P online pet pharmacy in canada = 0.01), while the change from baseline to follow-up for the fluoxetine arm decreased by -8.9 HAM-D points (P)
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