Natasha Sane | PubMed Health

PubMed2006

Free T4 index and clinical outcome in patients with depression.

INTRODUCTION: Many studies of patients with major depression have reported that a significant decrease in serum free T(4) index is associated with specific treatments; what has been unanswered is whether these observations are generalizable. This study evaluated baseline thyroid function and its relationship to rapidity of treatment response as measured by hospital length of stay (HLOS). METHODS: Admission thyroid indices and HLOS data were harvested from the medical record of patients hospitalized for depression, both unipolar and bipolar. The relationship between admission thyroid indices and HLOS was evaluated using survival models. RESULTS: Controlling for age and year of discharge, an inverse relationship between FT(4) index (FT(4)I) and HLOS was present in men, but not in women. The mean HLOS stratified by gender and median FT(4)I was 50% shorter in men with a relatively high FT(4)I in comparison to the other three groups. LIMITATIONS: This is a retrospective study limited by the absence of a structured diagnostic psychiatric interview and prospective controlled antidepressant evaluation. CONCLUSION: These data would suggest that a relatively elevated FT(4) index in depressed men is associated with a faster antidepressant response time. Prospective study is encouraged to further clarify this potential thyroid/gender relationship and whether thyroid supplementation can accelerate the improvement in depression as measured by HLOS.

Adult↗

PubMed2002

MethyPatch Noven.

Noven Pharmaceuticals is developing a transdermal patch formulation of methylphenidate for the treatment of attention deficit hyperactivity disorder (ADHD) [325808]. Phase III trials were completed in February 2002 [438893]; at this time, the company predicted a 2003 launch for the product [441478]. In April 2002, based on pivotal phase III trial results, Noven expected to file an NDA with the FDA in mid-2002 and to launch the product in the second half of 2003 [445181]. In June 2002, the NDA was filed [456552]. The original phase III trials were completed in the first quarter of 2001 [407254]. However, preliminary analysis of the phase III trial, reported in April 2001, suggested that a supplemental study would be required to support the filing [403771]. At this time, an NDA filing, originally planned for the second quarter of 2001, was rescheduled for the first half of 2002 [400122], [407640], [410285], [441478]. As of August 2001, the supplemental study was expected to begin in autumn of that year [417877]. In October 2001, enrolment was initiated in Noven's pivotal, double-blind, placebo-controlled, multicenter phase III study of MethyPatch [427321], and it was completed in February 2002 [438893]. In May 2001, the company was issued patent US-06210705 relating to the transdermal delivery of methylphenidate for the treatment of ADHD [410285]. In June 2001, ABN AMRO predicted sales of US $61 million in 2002, rising to US $74 million in 2005 [422762]. Analysts at Morgan Stanley predicted in May 2002 that the product would make US sales of US $9.1 million in 2003, rising to US $22.5 million in 2006 [454573].

Administration, Cutaneous↗