A pooled analysis of gender and trauma-type effects on responsiveness to treatment of PTSD with venlafaxine extended release or placebo.

Objective: To examine effects of gender and trauma type on response to treatment with venlafaxine extended release (ER) or placebo in patients with posttraumatic stress disorder (PTSD).

Method: Data were pooled from 2 flexible-dose, parallel-group, randomized, double-blind, placebo-controlled trials: a 12-week trial conducted in the United States (March 2001 to December 2002) and a 24-week trial conducted in 12 countries outside the United States (October 2001 to December 2003). Six hundred eighty-seven outpatients with DSM-IV-diagnosed PTSD and a 17-item Clinician-Administered PTSD Scale abbreviated 1-week Symptom Status version (CAPS-SX-17) score > or = 60 were randomly assigned to treatment with venlafaxine ER (37.

An analysis of correlations among four outcome scales employed in clinical trials of patients with major depressive disorder.

Background: The 17-item Hamilton Depression Rating Scale (HAM-D 17) remains the 'gold standard' for measuring treatment outcomes in clinical trials of depressed patients. The Montgomery Asberg Depression Rating Scale (MADRS), Clinical Global Impressions-Severity (CGI-S) and -Improvement (CGI-I) scales are also widely used.

Objective: This analysis of data from 22 double-blind, placebo-controlled clinical studies of venlafaxine in adult patients with major depressive disorder was aimed at assessing correlations among these 4 scales.

Comparison of the pharmacokinetics of venlafaxine extended release and desvenlafaxine in extensive and poor cytochrome P450 2D6 metabolizers.

Background: The goal of this study was to evaluate the impact of cytochrome P450 2D6 extensive metabolizer (EM) or poor metabolizer (PM) status on the pharmacokinetics of single doses of venlafaxine extended release (ER) and desvenlafaxine (administered as desvenlafaxine succinate) in healthy adults.

Methods: In an open-label, crossover study, 14 healthy volunteers (aged 18-55 years; 7 EMs and 7 PMs) received, in randomized sequence, single doses of venlafaxine ER 75 mg/d or desvenlafaxine 100 mg/d. Cytochrome P450 2D6 genotyping was performed, and plasma drug levels were measured.

The effects of desvenlafaxine and paroxetine on the pharmacokinetics of the cytochrome P450 2D6 substrate desipramine in healthy adults.

The potential for cytochrome P450 (CYP) 2D6 substrates to interact with desvenlafaxine (administered as desvenlafaxine succinate) and paroxetine was evaluated. In an open-label, crossover study, 20 healthy volunteers (aged 21-50) were randomized to 2 series of 9 days each of desvenlafaxine (100 mg/d) or paroxetine (20 mg/d), separated by a 5-day washout. The CYP2D6 substrate desipramine (50 mg) was administered alone on day 1 and coadministered on day 6 of dosing with either desvenlafaxine or paroxetine.

Assessing the efficacy of 2 years of maintenance treatment with venlafaxine extended release 75-225 mg/day in patients with recurrent major depression: a secondary analysis of data from the PREVENT study.

The objective of this study was to evaluate the long-term efficacy of venlafaxine extended release (ER) < or =225 mg/day in patients with recurrent major depressive disorder (MDD). In this double-blind trial, outpatients with recurrent MDD (N=1096) were randomized to 10 weeks of acute-phase treatment with venlafaxine ER (75-300 mg/day) or fluoxetine (20-60 mg/day) followed by a 6-month continuation phase and two consecutive 12-month maintenance phases. At the start of each maintenance period, venlafaxine ER responders were randomized to double-blind venlafaxine ER or placebo.

Onset of activity and time to response on individual CAPS-SX17 items in patients treated for post-traumatic stress disorder with venlafaxine ER: a pooled analysis.

This pooled analysis of data from two randomized, placebo-controlled trials of venlafaxine extended release (ER) assessed onset of activity and time to response on the 17 symptoms of post-traumatic stress disorder (PTSD) listed in DSM-IV and measured by the 17-item Clinician-Administered PTSD Scale (CAPS-SX17). The intent-to-treat (ITT) population comprised 687 patients (placebo, n=347; venlafaxine ER, n=340). Significant (p<0.

The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the 2-year and combined maintenance phases.

Objective: To report second-year results from the 2-year maintenance phase of a long-term study to evaluate the efficacy and safety of venlafaxine extended release (ER) in preventing recurrence of depression.

Method: Outpatients with recurrent unipolar depression (DSM-IV criteria; N = 1096) were randomly assigned in a 3:1 ratio to 10 weeks of treatment with venlafaxine ER or fluoxetine. Responders (17-item Hamilton Rating Scale for Depression [HAM-D(17)] total score or= 50% decrease from baseline) entered a 6-month, double-blind continuation phase on the same medication.

The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) study: outcomes from the acute and continuation phases.

Background: We evaluated the comparative efficacy and safety of venlafaxine extended release (ER) and fluoxetine in the acute and continuation phases of treatment.

Methods: In this multicenter, double-blind study, outpatients with recurrent unipolar major depression were randomly assigned to receive venlafaxine ER (75-300 mg/day; n = 821) or fluoxetine (20-60 mg/day; n = 275). After a 10-week acute treatment phase, responders entered a 6-month continuation phase of ongoing therapy with double-blind venlafaxine ER (n = 530) or fluoxetine (n = 185).

Analysis of the rate of improvement of specific psychic and somatic symptoms of general anxiety disorder during long-term treatment with venlafaxine ER.

Introduction: Generalized anxiety disorder (GAD) is a chronic illness with psychic and somatic symptoms that do not respond uniformly in the first weeks of treatment.

Methods: A post-hoc analysis of pooled data from five placebo-controlled, double-blind, randomized studies in non-depressed GAD patients treated with venlafaxine extended release (ER) or placebo was performed to determine the temporal response of psychic and somatic symptoms to treatment over 8 weeks. Two of the studies included extension phases of up to 6 months, the results of which were also analyzed here.

Longitudinal effect of olanzapine on fasting serum lipids: a randomized, prospective, 4-month study.

Our objective was to compare lipid profiles of schizophrenic patients treated with conventional antipsychotics or risperidone to those of patients switched to olanzapine. Our results indicate that in patients switched to olanzapine, fasting serum lipids initially increased then returned to pretreatment levels, and endpoint lipid levels were not significantly different from those in patients remaining on conventional antipsychotics or risperidone.

The Metabolic Syndrome in Patients With Severe Mental Illnesses.

BACKGROUND: Since the introduction of the first atypical antipsychotics in the early 1990s, this class of medication has been increasingly relied upon for the treatment of a variety of patients with psychotic and mood disorders.DATA SOURCES: The following retrospective review was derived from the MEDLINE database using the search terms metabolic syndrome, insulin resistance, obesity, diabetes, severe mental illness, schizophrenia, bipolar disorder, mood disorders, depression, unipolar depression, and prevalence from 1966 to the present. LITERATURE SYNTHESIS: Coincident with the growing usage of these agents, there have been a growing number of literature reports of changes in metabolic homeostasis among patients taking these medications.

An excitement subscale of the Positive and Negative Syndrome Scale.

Background: We sought to develop and validate an excitement subscale from the Positive and Negative Syndrome Scale (PANSS) to allow the investigation of mania-like excitement symptoms in clinical trials of patients with schizophrenia using the PANSS and to provide clinicians with a short assessment tool for these states.

Methods: Baseline PANSS data from six double-blind, randomized registration trials of olanzapine, three in schizophrenia and three in acute bipolar mania, were used in these post-hoc analyses. Schizophrenia study data were pooled and randomly split in half.

Mood Disorders in Family Practice: Beyond Unipolarity to Bipolarity.

Primary care physicians increasingly have treated depressive disorders over the last decade. Unrecognized bipolar disorder, sometimes misdiagnosed as unipolar depression, may lead to treatment resistance or nonresponse. We describe differences between unipolar and bipolar disorders, focusing on recognition, diagnosis, and treatment of bipolar spectrum disorders such as bipolar I, bipolar II, antidepressant-induced mania, and cyclothymia.

Biomarkers in psychotropic drug development.

The authors review the use of biomarkers in the development of novel psychotropic agents. They briefly review clinical drug development, emphasizing the importance of incorporating biomarkers. For the development of psychotropic agents, biomarkers are particularly useful for assessing central nervous system exposure and effects and for serving as surrogate measures for safety and efficacy.