Forest Laboratories, Inc announced the results of a recently completed placebo-controlled study of Lexapro (escitalopram oxalate) in children and adolescents. Patients receiving Lexapro did not demonstrate statistically significant separation from placebo in the primary efficacy measure, the mean change from baseline in the Children's Depression Rating Scale-Revised (CDRS-R) score, a company release said.
The study was just completed and the safety data reported to the US FDA. The study found that Lexapro was well tolerated in both children and adolescents with no significant difference in withdrawal rates due to adverse events with Lexapro as compared to placebo.
A separate analysis evaluating the frequency of suicide-related events and worsening of depression found that two placebo-treated patients reported suicide-related events and one placebo patient reported worsening of depression, whereas only one Lexapro-treated patient reported a suicide-related event and no Lexapro-treated patient reported worsening of depression.
Forest believes the results of this trial in addition to the paediatric depression trials of citalopram (marketed as Celexa in the US) show that there is no added risk of suicide or worsening of depression due to the use of these products in paediatric patients. There have been no suicides observed in the paediatric placebo- controlled clinical trial experience with either citalopram or Lexapro.
These initial analyses revealed positive trends in some of the secondary efficacy measures for the group of patients treated with Lexapro as compared to the placebo group.
"It is important to better define the role antidepressants can play in treating this population," said Lawrence S Olanoff, executive vice president and chief scientific officer, Forest Laboratories, Inc. "The two US studies are comparable in design and studied similar patient populations. We recognize that the European study is limited in its comparability to the US experience due to its unique design and patient population -which included both hospitalized patients and outpatients, many of whom had a history of more complicated depressive disorders. We believe that the aggregate safety and efficacy experience with Celexa and Lexapro in paediatric patients remains encouraging and that further study is warranted," he added.
Forest plans to discuss with the FDA the initiation of new paediatric studies with Lexapro in the US with the goal of ultimately achieving approval of its use in paediatric patients with major depressive disorder.
About 260 patients, ages 6 to 17 with major depressive disorder and a CDRS-R score of 40 or greater, participated in the randomized, double-blind, multi-centre, flexible dose study.
The initial results of the trial indicated that the change from baseline for the CGAS and the CGI-S scores appeared greater for the Lexapro treated group compared to the placebo group, however the differences did not quite achieve statistical significance (p= 0.07 and 0.06, respectively). When these same efficacy measures were analyzed for those subjects who remained in the study through the eight-week assessment, statistically significant (p < 0.05) improvements were seen in the Lexapro group for both these assessments by comparison to the placebo group.
Lexapro is the fastest-growing selective serotonin reuptake inhibitor (SSRI) and was approved by the US FDA in August 2002 for both the initial and maintenance treatment of major depressive disorder in adults and in December 2003 for the treatment of generalized anxiety disorder in adults.