Early M-Protein Dynamics Predicts Progression-Free Survival in Patients With Relapsed/Refractory Multiple Myeloma.

This study aimed to predict long-term progression-free survival (PFS) using early M-protein dynamic measurements in patients with relapsed/refractory multiple myeloma (MM). The PFS was modeled based on dynamic M-protein data from two phase III studies, POLLUX and CASTOR, which included 569 and 498 patients with relapsed/refractory MM, respectively. Both studies compared active controls (lenalidomide and dexamethasone, and bortezomib and dexamethasone, respectively) alone vs.

A phase 1b study of trametinib, an oral Mitogen-activated protein kinase kinase (MEK) inhibitor, in combination with gemcitabine in advanced solid tumours.

Purpose: This phase 1b study determined the safety, tolerability, and recommended phase 2 dose (RP2D) and schedule of trametinib in combination with gemcitabine. Secondary objectives included assessment of clinical activity and steady-state pharmacokinetics.

Methods: Adults with advanced solid tumours, adequate organ function and Eastern Co-operative Oncology Group performance status (ECOG PS) ⩽ 1 were eligible.

Results from 2 randomized, double-blind, placebo-controlled studies of the novel NK1 receptor antagonist casopitant in patients with major depressive disorder.

Clinical study results for neurokinin (NK) receptor antagonists in the treatment of depression have been mixed, with Phase III studies failing to fulfill the early promise demonstrated in Phase II studies. Casopitant, a selective NK1 antagonist that achieves nearly complete receptor occupancy was studied in 2 randomized, placebo-controlled, double-blind, Phase II trials in depressed outpatients to test the hypothesis that nearly complete NK1 receptor occupancy is required to achieve antidepressant efficacy. Study 092 used an interactive voice response system to recruit depressed patients with baseline Hamilton Depression (17-item, HAMD17) total scores higher than 24 who were randomized to fixed-dose casopitant 30 mg/d, 80 mg/d, or placebo for 8 weeks (n = 356).

A novel approach to rater training and certification in multinational trials.

Clinical trials are becoming increasingly international in scope. Global studies pose unique challenges in training and calibrating raters owing to language and cultural differences. Recent findings that poorly conducted interviews reduce study power, makes attention to raters' clinical skills critical.

A new approach to rater training and certification in a multicenter clinical trial.

Recent evidence demonstrates that the quality of raters' applied clinical skills is directly related to study outcome. As such, the training and evaluation of raters' clinical skill in administering symptom-rating scales is essential before being certified to rate patients in clinical trials. This study examined a novel approach to rater training and certification that focused on both conceptual knowledge and applied skills.

Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: Remission Analysis Following a Randomized, Double-Blind, Placebo-Controlled Trial.

Objective: To compare the efficacy and safety of paroxetine controlled release (CR) (12.5 mg/day or 25 mg/day) versus placebo in premenstrual dysphoric disorder (PMDD).Method: A double-blind, randomized, placebo-controlled trial was conducted over 3 menstrual cycles in women aged 18-45 years with confirmed DSM-IV PMDD in 47 outpatient centers across the United States and Canada from November 1999 to January 2002.

Hypertension and the rate of cognitive decline in patients with dementia of the Alzheimer type.

Hypertension has been suspected of being associated with Alzheimer disease (AD). To study this problem, a case-control study investigating the association between hypertension and cognitive decline was conducted as a secondary analysis of data from more than 700 patients diagnosed with AD who had been randomly assigned to the placebo arm of a clinical trial. Additional analyses were undertaken to investigate the effects of baseline disease severity, age, gender, apolipoprotein genotype, and the use of antihypertensive medication in this population.

Paroxetine controlled release for premenstrual dysphoric disorder: a double-blind, placebo-controlled trial.

Background: Better characterization of safety and efficacy of multiple doses of selective serotonin reuptake inhibitors for the treatment of a wider range of symptoms of premenstrual dysphoric disorder (PMDD) will provide clinicians with flexibility to provide symptom relief along with acceptable tolerability. This study was designed to assess the efficacy and tolerability of multiple doses of paroxetine controlled release (CR) in PMDD.

Methods: In a multicenter (43 outpatient U.

Paroxetine in the treatment of generalised anxiety disorder.

Paroxetine is a selective serotonin re-uptake inhibitor useful in the treatment of a wide range of psychiatric disorders. Generalised anxiety disorder (GAD) is characterised by excessive persistent anxiety and worry about a number of events and activities occurring on more days than not for at least 6 months. GAD is the most common anxiety disorder in primary care settings.

Paroxetine treatment of generalized anxiety disorder: a double-blind, placebo-controlled study.

Objective: This study assessed the efficacy of two fixed doses of paroxetine in the treatment of generalized anxiety disorder.

Method: Outpatients (N=566) with generalized anxiety disorder and no other axis I disorder were eligible if they scored >/=20 on the Hamilton Rating Scale for Anxiety (with a score of 2 or higher on the anxious mood and tension items). Following a 1-week placebo run-in phase, patients were randomly assigned to 8 weeks of treatment with paroxetine, 20 or 40 mg/day, or placebo.