Publications by authors named "Philip Jochelson"
Background: Solriamfetol is approved (US and EU) for excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea.
Objectives: Evaluate solriamfetol safety/efficacy for EDS in Parkinson's disease (PD).
Methods: Phase 2, double-blind, 4-week, crossover trial: adults with PD and EDS were randomized to sequence A (placebo, solriamfetol 75, 150, 300 mg/d), B (solriamfetol 75, 150, 300 mg/d, placebo), or C (placebo).
Objective: Ranolazine is an antianginal drug that mediates its effects by inhibition of cardiac late sodium current. Although ranolazine is not approved for the treatment of type 2 diabetes, in post hoc analyses of pivotal angina trials, ranolazine was associated with reductions in percent glycosylated hemoglobin (HbA1c) in subjects with type 2 diabetes. The study prospectively assessed the safety and efficacy of ranolazine in subjects with type 2 diabetes with inadequate glycemic control managed by lifestyle alone.
View Article and Find Full Text PDFStudy Objectives: To evaluate the efficacy and safety of doxepin (DXP) 3 mg and 6 mg in adults diagnosed with primary insomnia.
Design And Methods: The study was a randomized, double-blind, parallel-group, placebo-controlled trial. Patients meeting DSM-IV-TR criteria for primary insomnia were randomized to 35 days of nightly treatment with DXP 3 mg (n=75), DXP 6 mg (n=73), or placebo (PBO; n=73), followed by 2 nights of single-blind PBO to evaluate discontinuation (DC) effects.
Background: Doxepin tablets have recently been approved in the United States in doses of 3 and 6 mg for the treatment of insomnia characterized by difficulty with sleep maintenance.
Objective: Because no previous thorough QT evaluation of doxepin has been conducted, the primary objective of this study was to assess the highest recommended dose (6 mg) and a supratherapeutic amount (50 mg) of doxepin on cardiac repolarization under steady-state conditions in healthy adult subjects.
Methods: Male and female volunteers aged 18 to 45 years were randomized to receive double-blind doxepin or placebo for 7 days, or 6 days of double-blind placebo before one open-label administration of 400-mg moxifloxacin on day 7.
Article Synopsis
- The study assessed the effects of doxepin (1 mg and 3 mg) on elderly patients suffering from chronic primary insomnia over 12 weeks compared to a placebo.
- Doxepin 3 mg showed notable improvements in key sleep metrics like wake time after sleep onset, total sleep time, and sleep efficiency, with these advantages being consistent throughout the study.
- Both doses of doxepin were well tolerated, demonstrating positive outcomes in sleep quality and global impression scales, alongside low rates of discontinuation and similar safety profiles among the treatment groups.
Introduction: The efficacy and safety of doxepin (DXP) 6mg tablets were evaluated in healthy adults in a model of transient insomnia.
Methods: This was a randomized, double-blind, parallel-group, placebo-controlled study in healthy adults using a model of transient insomnia. A first-night effect combined with a 3-h phase advance was implemented to induce transient insomnia in healthy adults.