Depression (Adolescent)

December 18, 2017

Sage Therapeutics announced positive top-line results from the phase II, double-blind, placebo-controlled clinical trial of SAGE-217 in the treatment of 89 adult patients with moderate to severe major depressive disorder (MDD). In the trial, treatment for 14 days with SAGE-217 was associated with a statistically significant mean reduction in the Hamilton Rating Scale for Depression (HAM-D) 17-Item total score from baseline to Day 15 (the time of the primary endpoint) of 17.6 points for SAGE-217, compared to 10.7 for placebo (p<0.0001). Statistically significant improvements were observed in the HAM-D compared to placebo by the morning following the first dose through Week 4 and the effects of SAGE-217 remained numerically greater than placebo through the end of follow-up at week six. At day 15, 64% of patients who received SAGE-217 achieved remission, defined as a score of seven or less on the HAMD scale, compared with 23% of patients who received placebo (p=0.0005). Other secondary endpoints were all similarly highly significant at day 15 (p≤0.002). SAGE-217 was generally well-tolerated with no serious or severe adverse events; the most common adverse events (AEs) in the SAGE-217 group were headache, dizziness, nausea, and somnolence. A low rate of discontinuations due to AEs was reported; overall reports of AEs were similar between drug (53%) and placebo (46%), with a safety profile consistent with that seen in earlier trials. SAGE-217 was granted Fast Track Designation by the FDA in May 2017.

November 20, 2017

Sage Therapeutics announced positive top-line results from two phase III clinical trials with its proprietary i.v. formulation of brexanolone (USAN; formerly SAGE-547) in postpartum depression (PPD). The Hummingbird program included two phase III multicenter, randomized, double-blind, parallel-group, placebo-controlled trials (Study 202B and Study 202C). Trial participants in 202B were required to have a Hamilton Rating Scale for Depression (HAM-D) score of 26 or above prior to treatment. These patients were randomized to one of three treatment groups (brexanolone 90μg/kg/hour, brexanolone 60μg/kg/hour, or placebo) on a 1:1:1 basis. Trial participants in 202C were required to have a HAM-D score of between 20 and 25 prior to treatment. These patients were randomized to one of two treatment groups (brexanolone 90μg/kg/hour or placebo) on a 1:1 basis. Brexanolone achieved the primary endpoint in both trials, a mean reduction from baseline in the HAM-D total score compared to placebo at 60 hours (Study 202B: p=0.0242 for 90µg/kg/h dose and p=0.0011 for 60µg/kg/h dose; Study 202C: p=0.0160 for 90µg/kg/h dose). Patients treated with brexanolone demonstrated mean reductions from baseline in HAM-D total scores of 14 to 20 points at 60 hours maintained to 30 days in both trials. Brexanolone was generally well-tolerated and showed a similar safety profile as seen in earlier studies.

May 29, 2017

Sunovion Pharmaceuticals issued results of a phase III clinical study evaluating Latuda (lurasidone HCI) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression). In the six-week, randomized, double-blind, placebo-controlled study, 347 children and adolescents 10 to 17 years of age received LATUDA flexibly dosed (20 to 80mg/day) or placebo. LATUDA was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo, based on the primary efficacy endpoint of change from baseline to week six on the Children’s Depression Rating Scale, Revised (CDRS-R) total score (-21.0 vs. -15.3; effect size = 0.45, p<0.0001). Statistically significant and clinically relevant change from baseline to week six on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) was also seen with LATUDA compared to placebo (-1.49 vs. -1.05; effect size = 0.44, p<0.0001). LATUDA was generally well-tolerated. The most common treatment-emergent adverse events (TEAEs) reported for LATUDA compared to placebo were nausea (16% vs. 5.8%), somnolence (9.1% vs. 4.7%), weight gain (6.9% vs. 1.7%), vomiting (6.3% vs. 3.5%), dizziness (5.7% vs. 4.7%) and insomnia (5.1% vs. 2.3%). LATUDA is currently indicated in the U.S. for the treatment of adults with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate and for the treatment of schizophrenia in adults and adolescents (13 to 17 years of age). These data have been submitted to the FDA to support an sNDA.

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.