Clinical Trials Resource Center

Depression (Adult and Geriatric)

July 18, 2016

Sage Therapeutics released results of a phase II trial of SAGE-547 for the treatment of severe postpartum depression (PPD). The multicenter, placebo-controlled, double-blind, 1:1 randomization trial was designed to enroll up to 32 women. The population studied were women with severe PPD (HAM-D ≥26) who developed severe depression either in the third trimester or within four weeks of childbirth. At baseline, the mean HAM-D scores for both groups was greater than 28. The primary objective of the trial was to evaluate the effect of SAGE-547 on depression as measured by the HAM-D score, compared to placebo, at 60 hours. In addition, patients were monitored during a 30-day follow-up period to assess both safety and efficacy. SAGE-547 achieved the primary endpoint of a significant reduction in the HAM-D score compared to placebo at 60 hours (p=0.008). This represented a greater than 20-point mean reduction in the depression scores of the SAGE-547 group at the primary endpoint of 60 hours through trial completion with a greater than 12-point difference from placebo. The statistically significant difference in treatment effect began at 24 hours, (p=0.006) with an effect that was maintained at similar magnitude through to the 30-day follow-up (p=0.01). Remission from depression, as determined by a HAM-D ≤7, measured at 60 hours, was seen in seven of 10 in the SAGE-547 group compared with one of 11 in the placebo group (p=0.008). Similarly, at 30 days, seven of 10 of the SAGE-547 group and two of 11 in the placebo group were in remission (p=0.03). SAGE-547 was found to be generally well-tolerated with no serious adverse events reported during the treatment and follow-up periods. The company has initiated an expansion program to determine optimal dosing of SAGE-547 in PPD.

December 15, 2014

Otsuka Pharmaceutical and H. Lundbeck issued results of a phase III study of brexpiprazole as adjunctive treatment to antidepressant therapy (ADT) in patients with major depressive disorder (MDD). Patients with MDD who failed to reach adequate response during one to three treatment attempts with ADT were enrolled and received an additional trial with a (single-blind) ADT for eight weeks. Those patients who still failed to reach an adequate response throughout this phase were then randomized (double-blind) to ADT and brexpiprazole or ADT and placebo for six weeks. Adjunctive brexpiprazole showed greater improvement than adjunctive placebo in MADRS (Montgomery–Åsberg Depression Rating Scale) total score at week six in the efficacy population per final protocol in study 1 (2mg+ADT [N=175]: -3.21, p=0.0002), and in study 2 (1mg+ADT [N=211]: -1.30, p=0.0737; 3mg+ADT [N=213]: -1.95, p=0.0079). Similar results were observed for the efficacy population in both studies. Discontinuations due to adverse events were low across all groups (1mg = 1.3%, 2mg = 3.2%, 3mg = 3.5%, placebo = 0.7%) and only one patient discontinued due to lack of efficacy (in the brexpiprazole 1mg group). A NDA for brexpiprazole has been filed with the FDA and the PDUFA date is in July 2015.

November 24, 2014

Neuralstem released results of a phase Ib study of NSI-189 for major depressive disorder (MDD). In this single-site study, 24 patients with confirmed diagnosis of recurrent MDD 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. All subjects stayed in-clinic for the 28-day treatment period. After this period, the subjects returned to the clinic for follow-up measures for up to an additional eight weeks post-dosing. A significant number of patients on active treatment demonstrated clinical improvement by a reduction in total Montgomery-Asberg Depression Rating Scale (MADRS) scores >/= 15.9 points, which continued eight weeks after dosing stopped. The company plans to launch a large, multi-site, phase II study in the second quarter of 2015.

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.

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