Table 2 Summary of studies characteristics
Study | Number of Studies Patients on Flx | Comparator(s) | Disease and Patient Population | Methodology |
|---|---|---|---|---|
Addis 2000 [36] | 4 studies 367 pts | TCAs | Pregnant in the first trimester | Medline and Embase search up to August 1996. REPROTOX and Current content up to November 1996. Manual retrieve from conferences acts. Only cohort studies eligible for the analysis. Weighted average of fetal risk for major malformations. Mantel-Haenszel odds ratio and overall 95% confidence interval. |
Bacaltchuk 2003 [37] | 16 studies 449 pts | Placebo TCAs MAOIs | Bulimia nervosa | MEDLINE (1966 to December 2000), EMBASE (1980-December 2000), PsycLIT (to December 2000), LILACS & SCISEARCH (to 1997) search. Randomized, placebo-controlled trials in which antidepressant medications were compared to placebo to reduce the symptoms of bulimia nervosa in patients of any age or gender. The main objective was the evaluation of antidepressant medications as clinically effective for the treatment of bulimia nervosa. |
Beasley 2000 (1) [38] | 25 studies 1258 pts | Placebo TCAs | Major Depressive Disorder | Data from US IND double-blind, randomized controlled clinical trials. Spontaneously reported treatment emergent adverse events (regardless of cause), reasons for discontinuation, and events leading to discontinuation were compared between groups. Mantel-Haenszel incidence difference after Cochran test; Der-Simonian-Laird test, when appropriate. |
Beasley 2000 (2) [39] | 3 studies 233 pts | Placebo | Major Depression | Data from US IND double-blind, randomized controlled clinical trials using fluoxetine fixed dose 20 mg/die on adult patients. Only efficacy data (response rate, depression improvement) included in this review because safety data are included in the Beasley 2000 article [28]. Whitehead and Whitehead method. Mantel-Haenszel incidence difference stratified by study. Der-Simonian-Laird test, when appropriate |
Beasley 1992 [40] | 17 studies 1765 pts | TCAs Placebo | Depression Suicidal acts | Data from US IND double-blind, randomized controlled clinical trials up to December 1989. Incidence of suicides. Suicide ideation acts and worsening in suicidal ideation. Binomial unconditional Mantel-Haenszel estimate. Mantel-Haenszel adjusted incidence difference. Pearson's chi-square test. |
Bech 2000 [41] | 30 studies 4120 pts | TCAs Placebo | Major Depression Short term effect | Data from US IND double-blind, randomized controlled clinical trials up to December 1992. Efficacy and discontinuations rate for acute treatment. Log odds ratio for binary data. Effect size analysis. Whitehead and Whitehead method. |
Cox 1993 [42] | 25 studies | Clomipramine Behavior therapy | OCD | MEDLINE (1975 to 1991), PsycLIT (1975 to 1991) search. Studies excluded if case studies, review paper, contained previously published data or did not contain the dependent variables of interest (severity of OCD symptoms, anxious and depressed mood assessed by a commonly used numeric scale). Effect size and Z-Score. |
Hoog 1999 [43] | 6 studies 746 pts | Placebo | Depression Pts over 55 | Data from US IND double blind, randomized controlled clinical trials up to December 1998. Changes in HAMD-17 total score, anxiety, agitation, and insomnia during treatment of depression. Treatment emergent adverse events and reasons for discontinuation. Mantel-Haenszel incidence difference with Sato's correction after Cochran test. Der-Simonian-Laird test, when appropriate. |
Tollefson 1994 [44] | 6 studies 962 pts | Placebo | Major Depression | Data from US IND double blind, randomized controlled clinical trials. Time of onset of antidepressant action and patient's discontinuation rates. Least squares means and standard error for the description of response variables. Cochran-Mantel-Haenszel statistic stratified by study. Kaplan.Meier estimate of the time to response and remission. Wilcoxon test and log rank test to evaluate the difference between the two distributions. |