Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial
Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1A partial agonist approved for major depressive disorder (MDD) treatment in adults. This was a 10-week, multicenter, double-blind, placebo-controlled and active-controlled, fixed-dose trial (NCT01473381). Adult patients with MDD (Diagnostic and Statistical Manual of Mental Disorders, 4th ed., text revision criteria) were randomized 1 : 1 : 1 : 1 to vilazodone 20 or 40 mg/day, citalopram 40 mg/day, or placebo. Primary efficacy: Montgomery–Åsberg Depression Rating Scale (MADRS); secondary effica...
Source: International Clinical Psychopharmacology - January 30, 2015 Category: Psychiatry Tags: Original Articles Source Type: research

Predictors of placebo response in bipolar depression
The aim of this work is to investigate placebo response rates in placebo-controlled randomized clinical trials (RCTs) of pharmacological therapy in bipolar depression (BPD) and to identify predictors of placebo response and clinical trial outcome in BPD. Medline/PubMed publication databases were searched for RCTs of oral drugs used as monotherapy for the treatment of BPD, published between January 1980 and September 2013. Data extracted from 12 manuscripts and one poster, representing a total of 17 clinical trials, were pooled. Pooled response rates for drug and placebo were 55.1 and 39.2%, corresponding to a risk ratio fo...
Source: International Clinical Psychopharmacology - January 30, 2015 Category: Psychiatry Tags: Original Articles Source Type: research

Quetiapine augmentation for depression: dosing pattern in routine practice
This study investigated the dosing patterns of quetiapine augmentation (QA) for major depressive disorder (MDD) in routine practice. Between 1 January 2009 and 31 May 2013, patients with a diagnosis of MDD who were receiving QA in conjunction with an ongoing antidepressant were recruited into this study. The electronic medical records and clinical data for a total of 977 patients were reviewed up to a year. Almost half the patients maintained QA treatment for more than 3 months. The mean duration of QA was ∼6 months, and the mean initial and maintenance doses were 23.6 and 40.7 mg/day, respectively (range=12.5&n...
Source: International Clinical Psychopharmacology - January 1, 2015 Category: Psychiatry Tags: Short Communication Source Type: research

Treatment of depressive symptoms in patients with schizophrenia: a randomized, open-label, parallel-group, flexible-dose subgroup analysis of patients treated with extended-release quetiapine fumarate or risperidone
The present analysis assessed the efficacy of extended-release quetiapine fumarate (quetiapine XR) versus risperidone in patients with schizophrenia and depressive symptoms [Hamilton Depression Rating Scale (HAM-D) score≥20 and a HAM-D item 1 score≥2]. This was a subanalysis of patients with schizophrenia from a randomized, open-label, parallel-group, flexible-dose study (NCT00640562) that also enrolled patients with schizoaffective disorder. The primary endpoint of this noninferiority study was change from baseline to week 12 in Calgary Depression Scale for Schizophrenia score (per protocol population). Overall, 114...
Source: International Clinical Psychopharmacology - January 1, 2015 Category: Psychiatry Tags: Original Articles Source Type: research

Adjunctive lisdexamfetamine in bipolar depression: a preliminary randomized, placebo-controlled trial
This study evaluated the efficacy and tolerability of lisdexamfetamine (LDX) in the treatment of bipolar depression. Twenty-five outpatients with bipolar I or II disorder and syndromal depression despite at least 4 weeks of stable mood stabilizer and/or antipsychotic therapy were randomized to receive LDX (N=11) or placebo (N=14) in an 8-week, prospective, parallel-group, double-blind study. In the primary longitudinal analysis, LDX and placebo produced similar rates of improvement in depressive symptoms as assessed by the Montgomery–Asberg Depression Scale. However, LDX was associated with a statistically significan...
Source: International Clinical Psychopharmacology - January 1, 2015 Category: Psychiatry Tags: Original Articles Source Type: research

Lithium in drinking water and suicide prevention: a review of the evidence
Suicide is a serious public health problem worldwide, and many nations are committed to developing prevention programmes to reduce the incidence of suicide. To date, several strategies have been proposed for suicide prevention, both at the population and at the individual level, some of which may be pharmacological. In particular, a substantial amount of data show that lithium significantly reduces mortality in patients with mood disorders. Initiating from this evidence, some recent studies have investigated whether a relationship might exist between levels of lithium in drinking water and mortality rates for suicide in th...
Source: International Clinical Psychopharmacology - January 1, 2015 Category: Psychiatry Tags: Review Article Source Type: research

Quetiapine augmentation for depression: dosing pattern in routine practice
This study investigated the dosing patterns of quetiapine augmentation (QA) for major depressive disorder (MDD) in routine practice. Between 1 January 2009 and 31 May 2013, patients with a diagnosis of MDD who were receiving QA in conjunction with an ongoing antidepressant were recruited into this study. The electronic medical records and clinical data for a total of 977 patients were reviewed up to a year. Almost half the patients maintained QA treatment for more than 3 months. The mean duration of QA was ∼6 months, and the mean initial and maintenance doses were 23.6 and 40.7 mg/day, respectively (range=12.5&n...
Source: International Clinical Psychopharmacology - December 5, 2014 Category: Psychiatry Tags: Short Communication Source Type: research

Safety and drinking outcomes among patients with comorbid alcohol dependence and borderline personality disorder treated with high-dose baclofen: a comparative cohort study
In France, the off-label use of high-dose baclofen (HDB) for alcohol dependence is spreading. HDB induces frequent neuropsychiatric adverse events (AEs). Borderline personality disorder (BPD) is a major axis-two psychiatric disorder that exposes to frequent comorbid alcohol dependence and increased risky behaviors. We investigated the drinking and safety outcomes of patients with BPD treated with HDB for comorbid alcohol dependence. In a prospective cohort of 204 patients with alcohol dependence treated by HDB, 23 patients fulfilled the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. criteria for BPD. We pai...
Source: International Clinical Psychopharmacology - December 5, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Clomipramine demethylation rate is important on the outcome of obsessive–compulsive disorder treatment
The aim of this study was to investigate the influence of demethylation rate on the outcome of obsessive–compulsive disorder patients treated with clomipramine. Eighteen patients meeting the DSM-IV criteria for obsessive–compulsive disorder received 150–300 mg of clomipramine daily in a single-blind design for 12 weeks. The patients were evaluated with the Clinical Global Impression scale and the Yale–Brown Obsessive–Compulsive Scale (YBOCS). Clinical assessment and serum measurements of clomipramine and desmethylclomipramine were carried out at baseline and after 3, 6, 8, 10, and 12 we...
Source: International Clinical Psychopharmacology - December 5, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin
We report data from a postmarketing surveillance study in Germany on the effects of 3 weeks of treatment with PRM on sleep in patients with insomnia during treatment and at early (1–2 days) and late (around 2 weeks) withdrawal. In total, 653 patients (597 evaluable) were recruited at 204 sites (mean age 62.7 years, 68% previously treated with hypnotics, 65% women). With PRM treatment, the mean sleep quality (on a scale of 1–5 on which 1 is very good and 5 is very bad) improved from 4.2 to 2.6 and morning alertness improved from 4.0 to 2.5. The improvements persisted over the post-treatment observation period. R...
Source: International Clinical Psychopharmacology - December 5, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Factors characterizing access and latency to first pharmacological treatment in Italian patients with schizophrenia, mood, and anxiety spectrum disorders
Latency to first pharmacological treatment [duration of untreated illness (DUI)] in psychiatric disorders can be measured in years, with differences across diagnostic areas and relevant consequences in terms of socio-occupational functioning and outcome. Within the psychopathological onset of a specific disorder, many factors influence access and latency to first pharmacotherapy and the present study aimed to investigate such factors, through an ad-hoc developed questionnaire, in a sample of 538 patients with diagnoses of schizophrenia-spectrum disorder (SZ), mood disorder (MD), and anxiety disorder (AD). Patients with SZs...
Source: International Clinical Psychopharmacology - December 5, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Increased lean body mass as an early indicator of olanzapine-induced weight gain in healthy men
One of the primary limitations of many psychiatric medications is weight gain, the mechanism of which remains to be fully elucidated. We conducted a 2-week double-blind placebo-controlled study on weight gain with olanzapine, which is frequently but unpredictably associated with this side effect, to address the possible mechanisms of weight gain independent of changes in the psychiatric condition for which it is prescribed. Healthy male volunteers were randomly assigned to olanzapine (5 mg/day for 7 days, then 10 mg/day for 7 days) or a matching placebo. Of the 24 participants, 19 completed the study (olanzap...
Source: International Clinical Psychopharmacology - December 5, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Treatment of depressive symptoms in patients with schizophrenia: a randomized, open-label, parallel-group, flexible-dose subgroup analysis of patients treated with extended-release quetiapine fumarate or risperidone
The present analysis assessed the efficacy of extended-release quetiapine fumarate (quetiapine XR) versus risperidone in patients with schizophrenia and depressive symptoms [Hamilton Depression Rating Scale (HAM-D) score≥20 and a HAM-D item 1 score≥2]. This was a subanalysis of patients with schizophrenia from a randomized, open-label, parallel-group, flexible-dose study (NCT00640562) that also enrolled patients with schizoaffective disorder. The primary endpoint of this noninferiority study was change from baseline to week 12 in Calgary Depression Scale for Schizophrenia score (per protocol population). Overall, 114...
Source: International Clinical Psychopharmacology - December 5, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Adjunctive lisdexamfetamine in bipolar depression: a preliminary randomized, placebo-controlled trial
This study evaluated the efficacy and tolerability of lisdexamfetamine (LDX) in the treatment of bipolar depression. Twenty-five outpatients with bipolar I or II disorder and syndromal depression despite at least 4 weeks of stable mood stabilizer and/or antipsychotic therapy were randomized to receive LDX (N=11) or placebo (N=14) in an 8-week, prospective, parallel-group, double-blind study. In the primary longitudinal analysis, LDX and placebo produced similar rates of improvement in depressive symptoms as assessed by the Montgomery–Asberg Depression Scale. However, LDX was associated with a statistically significan...
Source: International Clinical Psychopharmacology - December 5, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Lithium in drinking water and suicide prevention: a review of the evidence
Suicide is a serious public health problem worldwide, and many nations are committed to developing prevention programmes to reduce the incidence of suicide. To date, several strategies have been proposed for suicide prevention, both at the population and at the individual level, some of which may be pharmacological. In particular, a substantial amount of data show that lithium significantly reduces mortality in patients with mood disorders. Initiating from this evidence, some recent studies have investigated whether a relationship might exist between levels of lithium in drinking water and mortality rates for suicide in th...
Source: International Clinical Psychopharmacology - December 5, 2014 Category: Psychiatry Tags: Review Article Source Type: research

Efficacy of vilazodone on anxiety symptoms in patients with major depressive disorder
Anxiety symptoms are prevalent in patients with major depressive disorder. A post-hoc analysis of two phase III trials was conducted to evaluate the efficacy of vilazodone on depression-related anxiety. Using the 17-item Hamilton Depression Rating Scale (HAMD17) Anxiety/Somatization subscale, patients were classified as anxious or nonanxious. Improvements in depressive symptoms were based on least squares mean changes in HAMD17 and Montgomery–Asberg Depression Rating Scale total scores. Anxiety symptoms in the anxious subgroup were evaluated using Hamilton Anxiety Rating Scale (HAMA) total and subscale (Psychic Anxie...
Source: International Clinical Psychopharmacology - October 4, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Ondansetron or placebo in the augmentation of fluvoxamine response over 8 weeks in obsessive–compulsive disorder
The aim of this study was to investigate the efficacy and safety of ondansetron as an augmentative agent to fluvoxamine in the treatment of patients with obsessive–compulsive disorder (OCD). Forty-six men and women, aged 18–60 years, who fulfilled the diagnostic criteria of OCD on the basis of the DSM-IV-TR and had a Yale–Brown Obsessive Compulsive Scale (Y-BOCS) score of at least 21 were recruited into the study. The patients randomly received either ondansetron (8 mg/day) or placebo for 8 weeks. All patients received fluvoxamine (100 mg/day) for the first 4 weeks, followed by 200 mg...
Source: International Clinical Psychopharmacology - October 4, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Lack of efficacy of moclobemide or imipramine in the treatment of recurrent brief depression: results from an exploratory randomized, double-blind, placebo-controlled treatment study
‘Recurrent brief depression’ (RBD) is a common, distressing and impairing depressive disorder for which there is no current proven pharmacological or psychological treatment. This multicentre, randomized, fixed-dose, parallel-group, placebo-controlled study of the reversible inhibitor of monoamine oxidase moclobemide (450 mg/day) and the tricyclic antidepressant imipramine (150 mg/day) evaluated the potential efficacy of active medication, when compared with placebo, in patients with recurrent brief depression, recruited in the mid-1990s. After a 2–4-week single-blind placebo run-in period, ...
Source: International Clinical Psychopharmacology - October 4, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Psychomotor symptoms and treatment outcomes of ziprasidone monotherapy in patients with major depressive disorder: a 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial
The aim of this study was to evaluate efficacy of ziprasidone monotherapy for major depressive disorder (MDD) with and without psychomotor symptoms. In accordance with the sequential parallel comparison design, 106 MDD patients (age 44.0±10.7 years; female, 43.4%) were recruited and a post-hoc analysis was carried out on 12-week double-blind treatment with either ziprasidone (40–160 mg/day) or placebo, divided into two phases of 6 weeks each to the assigned treatment sequences, drug/drug, placebo/placebo, and placebo/drug. Psychomotor symptoms were evaluated on the basis of the Mini-International Neuropsychiat...
Source: International Clinical Psychopharmacology - October 4, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study
The objective of this study was to assess the long-term safety and efficacy of olanzapine long-acting injection (LAI). A 6-year, single-arm, open-label extension study of olanzapine LAI was conducted at 127 sites in 25 countries. Patients were 18–76 years of age, were diagnosed with schizophrenia or schizoaffective disorder (N=931), and had been previously enrolled in one of three clinical trials of olanzapine LAI. Patients received flexibly dosed (45-405 mg) olanzapine LAI every 2–4 weeks. The mean duration of exposure was ∼3 years. A total of 393 (42.2%) patients completed the study. The mean weight chang...
Source: International Clinical Psychopharmacology - October 4, 2014 Category: Psychiatry Tags: Original Articles Source Type: research

Prevalence of tardive dyskinesia in chronic male inpatients with schizophrenia on long-term clozapine versus typical antipsychotics
This study aimed to examine the prevalence and clinical associated variables of tardive dyskinesia (TD) in a large sample of Chinese inpatients with schizophrenia on long-term treatment with clozapine versus typical antipsychotics. A total of 584 male inpatients with schizophrenia on long-term clozapine (n=341) or typical antipsychotic (n=243) treatment were evaluated using the Abnormal Involuntary Movement Scale (AIMS). The patient’s psychopathology was assessed using the Positive and Negative Syndrome Scale. The overall prevalence of TD was 44.5%, with rates of 48.7% in the clozapine group and 38.7% in the typical ...
Source: International Clinical Psychopharmacology - October 4, 2014 Category: Psychiatry Tags: Short Communication Source Type: research

Pharmacological and behavioral management of some often-overlooked clozapine-induced side effects
This article reviews four of the milder but still bothersome side effects of clozapine that are fairly frequent and may have a negative impact on patients’ compliance with the treatment regime. We reviewed the available literature on the rate and management of four non-life-threatening side effects of clozapine, including hypersalivation, constipation, tachycardia, and nocturnal enuresis. We found a variety of pharmacological and behavioral strategies to manage these four side effects. There is, however, no consensus on a preferred strategy to control these distressing side effects and there are no guidelines. Psychi...
Source: International Clinical Psychopharmacology - October 4, 2014 Category: Psychiatry Tags: Review Articles Source Type: research

Pharmacokinetics of olanzapine long-acting injection: the clinical perspective
Olanzapine long-acting injection (OLAI) is a sustained-release depot antipsychotic for the treatment of schizophrenia in adults. Our objective was to explain the pharmacokinetics of OLAI to provide clinical insight. Simulation models and data from clinical trials are presented. Olanzapine concentrations were observed immediately upon injection. Half-life was ∼30 days, controlled by the slow rate of intramuscular absorption rather than the 30-h elimination rate-based half-life of oral olanzapine. As each injection builds on the drug still being released from previous injections, concentrations increase gradually until a...
Source: International Clinical Psychopharmacology - October 4, 2014 Category: Psychiatry Tags: Review Articles Source Type: research