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Depression (Adult and Geriatric)

November 17, 2014

Pfizer reported results of a phase IV study of Pristiq Extended Release Tablets 50mg and 100mg doses v. placebo focused on sexual function in adult patients diagnosed with major depressive disorder (MDD). In the phase IV, multi-center, randomized, double-blind placebo-controlled study, a total of 924 patients, 18-years or older, with a baseline HAM-D17 score of ≥20, were randomly assigned to Pristiq 50mg/day, Pristiq 100 mg/ day or placebo in a 1:1:1 ratio over an eight-week period. The primary efficacy end point for the study was the change from baseline in HAM-D17 total score at week eight. Incidence of sexual dysfunction was assessed using the ASEX data. In adult outpatients with MDD with baseline sexual activity and at least one post-baseline assessment, effects on ASEX total and item scores were comparable for the Pristiq 50mg and Pristiq 100mg groups and placebo. Rates of sexual dysfunction were comparable between each Pristiq dose and placebo at baseline (placebo, 52%; Pristiq 50mg/d, 56%; Pristiq 100mg/d, 54%) and at week eight (placebo, 45%; Pristiq 50mg/d, 49%; Pristiq 100mg/d, 47%).

July 28, 2014

Neuralstem released result of a phase I study of NSI-189 for major depressive disorder (MDD). The single-site study enrolled 24 patients with confirmed diagnosis of recurrent MDD who were treated orally with NSI-189 in three equal dose cohorts (8/dose cohort; 40mg QD, 40mg BID, and 40mg TID) for 28 days. Each dose cohort consisted of randomized, double-blinded, placebo controls at 1:3 ratio of placebo: drug. In a comprehensive assessment scale for depression (Symptoms of Depression Questionnaire or SDQ), the combined treatment group showed statistically significant improvement (p=0.02) after 28 days of the drug treatment compared to its randomized, double-blinded, placebo control group. There was a large effect size of 0.90. As measured by the assessment scale of cognitive and functioning deficits specifically designed for depressed patients (Cognitive and Physical Functioning Questionnaire or CPFQ), the treatment group was significantly better than the placebo group (p=0.01) at Day 28 with a large effect size of 0.94. As measured by both by SDQ and CPFQ, NSI-189’s significant and large treatment effects continued for eight weeks, even after the drug was withdrawn. Neuralstem plans to launch a large, multi-site phase II study by the first quarter of 2015.

October 3, 2005

DOV Pharmaceutical reported positive results of a phase II trial of their investigational triple-reuptake-inhibitor DOV 216,303 for the treatment of depression. Trial data indicated that the drug produced significant improvements relative to based line in symptom severity score on the HAM-D diagnostic scale (p<0.0001). These improvements were non-inferior to active control. No serious adverse events were noted, and to positive overall tolerability profile observed in earlier studies was maintained. This randomized, multicenter, double-blind, controlled study enrolled 67 patients, who received either 50 mg DOV 216,303 or 20 mg citalopram (an approved SSRI antidepressant), twice daily for 2 weeks.