Celexa Clinical Trials and Studies
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Celexa Clinical Trials and Studies
Celexa Clinical Efficacy Trials
The efficacy of Celexa as a treatment for depression was established in two placebo-controlled studies (of 4 to 6 weeks in duration) in adult outpatients (ages 18-66) meeting DSM-III or DSM-III-R criteria for major depression. Study 1, a 6-week trial in which patients received fixed CelexaTM doses of 10, 20, 40, and 60 mg/day, showed that CelexaTM at doses of 40 and 60 mg/day was effective as measured by the Hamilton Depression Rating Scale (HAMD) total score, the HAMD depressed mood item (Item 1), the Montgomery Asberg Depression Rating Scale, and the Clinical Global Impression (CGI) Severity scale. This study showed no clear effect of the 10 and 20 mg/day doses and the 60 mg/day dose was not more effective than the 40 mg/day dose. In study 2, a 4-week, placebo-controlled trial in depressed patients, of whom 85% met criteria for melancholia, the initial dose was 20 mg/day followed by titration to the maximum tolerated dose or a maximum dose of 80 mg/day. Patients treated with Celexa showed significantly greater improvement than placebo TM patients on the HAMD total score, HAMD item 1, and the CGI Severity score. In three additional placebo-controlled depression trials the difference in response to treatment between patients receiving CelexaTM and patients receiving placebo was not statistically significant, possibly due to high spontaneous response rate, smaller sample size, or in the case of one study, too low a dose.
In two long-term studies, depressed patients who had responded to CelexaTM during an initial 6 or 8 weeks of acute treatment (fixed doses of 20 or 40 mg/day in one study and flexible doses of 20-60 mg/day in the second study) were randomized to continuation of Celexa or to placebo. In both studies, patients receiving continued Celexa treatment experienced significantly lower relapse rates over the subsequent 6 months compared to those receiving placebo. In the fixed dose study, the decreased rate of depression relapse was similar in patients receiving 20 or 40 mg/day of Celexa.
Analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential responsiveness on the basis of these patient characteristics.
Comparison of Celexa Clinical Trial Results
Highly variable results have been seen in the clinical development of Celexa and all antidepressant drugs. Furthermore, in those circumstances when the drugs have not been studied in the same controlled clinical trial (s), comparisons among the results of studies evaluating the effectiveness of different antidepressant drug products are inherently unreliable. Because conditions of testing (e.g. patient samples, investigators, doses of the treatments administered and compared, outcome measures, etc.) vary among trials, it is virtually impossible to distinguish a difference in drug effect from a difference due to one of the confounding factors just enumerated.
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