scholarly journals Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies

CNS Spectrums ◽  
2014 ◽  
Vol 20 (2) ◽  
pp. 140-147 ◽  
Author(s):  
Henry A. Nasrallah ◽  
Josephine B. Cucchiaro ◽  
Yongcai Mao ◽  
Andrei A. Pikalov ◽  
Antony D. Loebel
Keyword(s):  
Depressive Symptoms ◽  
Rating Scale ◽  
Antipsychotic Agent ◽  
Pooled Analysis ◽  
Double Blind ◽  
Madrs Score ◽  
Level Data ◽  
Post Hoc ◽  
Major Depressive Episodes ◽  
Depressive Episodes

ObjectiveDepressive symptoms are common in schizophrenia and can worsen outcomes and increase suicide risk. Lurasidone is an atypical antipsychotic agent indicated for the treatment of schizophrenia and for the treatment of major depressive episodes associated with bipolar I disorder. This post hoc analysis evaluated the effect of lurasidone on depressive symptoms in patients with schizophrenia.MethodsPatient-level data were pooled from 4 similarly designed, double-blind, placebo-controlled, 6-week registration studies of lurasidone (40–160 mg/d) in adult patients with an acute exacerbation of schizophrenia. Changes in depressive symptoms, measured by the Montgomery–Åsberg Depression Rating Scale (MADRS), were analyzed for the overall sample and for subgroups of patients stratified by baseline MADRS scores.ResultsMADRS assessments at baseline and endpoint (day 42 or last observation carried forward [LOCF]) were available for 1330 patients. Patients receiving lurasidone experienced significantly greater decreases in MADRS score (–2.8, least-squares [LS] mean change, LOCF) compared with patients receiving placebo (–1.4, P < .001, effect size 0.24). Analysis of change in MADRS score (LOCF) by baseline symptom severity (MADRS score of ≥12, ≥14, ≥16, ≥18) showed significantly greater improvement for lurasidone-treated patients across all severity groups; effect sizes ranged from 0.25 to 0.34. Among patients with a baseline MADRS score of ≥12, depressive symptom remission (defined as MADRS score <10 at LOCF endpoint) was attained by 45.0% of lurasidone-treated patients and 36.3% of patients receiving placebo (P < .05).ConclusionsIn a pooled analysis of short-term, placebo-controlled studies, lurasidone significantly improved depressive symptoms in patients with schizophrenia.

scholarly journals Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials

CNS Spectrums ◽  
2014 ◽  
Vol 20 (2) ◽  
pp. 148-156 ◽  
Author(s):  
Stuart A. Montgomery ◽  
Carl P. Gommoll ◽  
Changzheng Chen ◽  
William M. Greenberg
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Extended Release ◽  
Rating Scale ◽  
Pooled Analysis ◽  
Major Depressive ◽  
Double Blind ◽  
Madrs Score ◽  
Wide Range ◽  
Remission Rates

Introduction/ObjectivePost hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release (ER) in subgroups of patients with major depressive disorder (MDD).MethodsData were pooled from 5 completed Phase II/III studies. Patients were categorized by sex, age, MDD duration, recurrence of MDD, current episode duration, number of prior episodes, and baseline Montgomery–Åsberg Depression Rating Scale (MADRS) score. Efficacy was evaluated by MADRS least squares (LS) mean change from baseline, response (MADRS improvement ≥50%), and remission (MADRS ≤10).ResultsIn the pooled population, treatment with levomilnacipran ER versus placebo resulted in greater improvement in MADRS score (−15.8 versus −12.9; LS mean difference, −2.9; P < .001) and higher response rates (44.7% versus 34.5%; P < .001). Comparable treatment effects were found in most subgroups. Remission rates in the overall population were higher for levomilnacipran ER versus placebo (27.7% versus 21.5%; P < .05); notably high remission rates were seen in patients with baseline MADRS score < 30 (48.8% versus 28.9%; P < .001).DiscussionClinically meaningful improvements in depressive symptoms were found across subgroups, including statistically significant outcomes for both response and remission.ConclusionLevomilnacipran ER was efficacious across a wide range of MDD patients, including men and women, ages 18–78, with varying histories and symptom severity.

A Double-blind Comparative Trial of Moclobemide v. Imipramine and Placebo in Major Depressive Episodes

1989 ◽  
Vol 155 (S6) ◽  
pp. 72-77 ◽  
Author(s):  
M. Versiani ◽  
U. Oggero ◽  
P. Alterwain ◽  
R. Capponi ◽  
F. Dajas ◽  
...  
Keyword(s):  
Rating Scale ◽  
Comparative Trial ◽  
Placebo Treatment ◽  
Major Depressive ◽  
Double Blind ◽  
Poor Tolerance ◽  
The Mean ◽  
Major Depressive Episodes ◽  
Depressive Episodes ◽  
Important Drug

Patients (n = 490) suffering from a major depressive episode according to DSM-III criteria were randomly allocated to groups receiving either moclobemide, imipramine, or placebo treatment. Subjects were treated as out-patients for 6 weeks. On overall assessment of efficacy and on results of the Hamilton Rating Scale for Depression, both moclobemide and imipramine were superior to placebo, but the differences between moclobemide and imipramine were not significant. Premature termination due to insufficient efficacy was more frequent with placebo than with moclobemide or with imipramine, these differences being significant. The overall assessment of tolerance clearly favoured placebo and moclobemide over imipramine. This was also reflected in the frequency of premature terminations due to poor tolerance, as well as in the frequency of adverse events, which were highest in the imipramine group. The only cardiovascular finding was an increase of the mean heart rate with imipramine, maximum at the end of week 1, while placebo and moclobemide displayed no relevant changes. There were no other important drug-related changes.

Clinical implications of directly switching antidepressants in well-treated depressed patients with treatment-emergent sexual dysfunction: a comparison between vortioxetine and escitalopram

CNS Spectrums ◽  
2019 ◽  
Vol 25 (1) ◽  
pp. 50-63 ◽  
Author(s):  
Paula L. Jacobsen ◽  
George G. Nomikos ◽  
Wei Zhong ◽  
Andrew J. Cutler ◽  
John Affinito ◽  
...  
Keyword(s):  
Sexual Dysfunction ◽  
Sexual Functioning ◽  
Rating Scale ◽  
Primary Study ◽  
Major Depressive ◽  
Double Blind ◽  
Scale Scores ◽  
Major Depressive Episodes ◽  
Depressive Episodes ◽  
Ssri Treatment

Objective:The objective of this work was to describe treatment-emergent sexual dysfunction (TESD) and tolerability following a switch from selective serotonin reuptake inhibitor (SSRI: citalopram, paroxetine, or sertraline) monotherapy to vortioxetine or escitalopram monotherapy in adults with well-treated major depressive disorder (MDD) and SSRI-induced sexual dysfunction.Methods:Data were analyzed from the primary study, an 8-week, randomized, double-blind, head-to-head study in which participants with well-treated depressive symptoms but experiencing TESD with SSRIs were directly switched to flexible doses (10/20 mg) of vortioxetine or escitalopram. Sexual functioning was assessed by the Changes in Sexual Functioning Questionnaire-14 (CSFQ-14), efficacy by the Montgomery–Åsberg Depression Rating Scale scores (MADRS) and Clinicians Global Impression of Severity/Improvement (CGI-S/CGI-I), and tolerability by adverse events. Efficacy and tolerability were assessed by pre-switch SSRI therapy where possible, and by participant characteristics.Results:Greater improvements in TESD were seen in the vortioxetine compared with escitalopram groups based on: participant demographics (≤45 years, women; P = 0.045), prior SSRI treatment (P = 0.044), number of prior major depressive episodes (MDEs) (1–3; P = 0.001), and duration of prior SSRI therapy (>1 year; P = 0.001). Prior SSRI treatment did not appear to influence the incidence or severity of TEAEs, except for nausea. Regardless of prior SSRI, both treatments maintained antidepressant efficacy after 8 weeks.Conclusion:Results suggest that vortioxetine is a safe and effective switch therapy for treating SSRI-induced sexual dysfunction in adults with well-treated MDD. Also, improvement in sexual dysfunction with vortioxetine or escitalopram may be influenced by prior SSRI usage, sex, age, and history of MDEs.

An intervention for depressive symptoms using a commercial game in a mental health impatient setting. (Preprint)

2019 ◽  
Author(s):  
Pablo Rodrigo Guzman Cortez ◽  
Matias Marzocchi ◽  
Neus Freixa Fontanals ◽  
Mercedes Balcells-Olivero
Keyword(s):  
Mental Health ◽  
Depressive Symptoms ◽  
Health Outcomes ◽  
Serious Games ◽  
Rating Scale ◽  
Depressive Symptomatology ◽  
Pilot Test ◽  
Potential Health ◽  
Depressive Episodes ◽  
Hamilton Rating Scale

BACKGROUND Computerized mental health interventions have shown evidence of their potential benefit for mental health outcomes in young users. All of the studied interventions available in the review and scientific literature can be classified as "serious games". Serious games are computerized interventions designed from the start with the objective of improving specific desired health outcomes. Moreover, there are reports of users experiencing subjective benefits in mental health after playing specific commercial games. These were games not intentionally made with a therapeutic objective in the design process. An example is the videogame "Journey", first released for the Playstation 3 console in 2012 which won "Game of the Year" in the 2013 D.I.C.E awards. The creator of the game describes the game as a short, 2-3-hour narrative experience in which the player goes through the "Hero's Journey" following a classic 3-part structure. There were more than 100 testimonials from players describing how the game helped them cope with psychological or personal issues. Some of them explicitly described recovering from depressive episodes through playing the game. OBJECTIVE To conduct a pilot test of the efficacy of the videogame Journey in reducing depressive symptoms in an acute impatient setting METHODS Depressive symptomatology was measured before and after the intervention using the Hamilton Rating Scale for Depression (HRSD) The intervention was conducted in an isolated room using a Playstation 3 console with the videogame "Journey" developed by Thatgamecompany. No internet access was allowed. The game was played over the course of 4 30-45 min sessions in a two week period. RESULTS The initial score in the Hamilton Rating Scale for Depression (HRSD) was 30, indicating a very severe depression. After the intervention the HRSD score was 10, showing a mild depression. CONCLUSIONS The Videogame Journey, a commercial game first available for the Playstation 3 console in 2012, was not created as a serious game with potential health benefits. Our pilot test is the first case report of a commercial game showing a potential effect in reducing depressive symptoms, which is consistent with the previous informal reports of users online.

Treating mixed mania/hypomania: a review and synthesis of the evidence

CNS Spectrums ◽  
2016 ◽  
Vol 22 (2) ◽  
pp. 177-185 ◽  
Author(s):  
Minoru Takeshima
Keyword(s):  
Depressive Symptoms ◽  
Acute Phase ◽  
Opposite Polarity ◽  
Mood Stabilizers ◽  
Current Evidence ◽  
Mixed States ◽  
Mixed Features ◽  
Broad Concept ◽  
Major Depressive Episodes ◽  
Depressive Episodes

The DSM–5 incorporates a broad concept of mixed states and captured ≥3 nonoverlapping symptoms of the opposite polarity using a “with mixed features” specifier to be applied to manic/hypomanic and major depressive episodes. Pharmacotherapy of mixed states is challenging because of the necessity to treat both manic/hypomanic and depressive symptoms concurrently. High-potency antipsychotics used to treat manic symptoms and antidepressants can potentially deteriorate symptoms of the opposite polarity. This review aimed to provide a synthesis of the current evidence for pharmacotherapy of mixed states with an emphasis on mixed mania/hypomania. A PubMed search was conducted for randomized controlled trials (RCTs) that were at least moderately sized, included a placebo arm, and contained information on acute-phase and maintenance treatments of adult patients with mixed episodes or mania/hypomania with significant depressive symptoms. Most studies were post-hoc subgroup and pooled analyses of the data from RCTs for acute manic and mixed episodes of bipolar I disorder; only two prospectively examined efficacy for mixed mania/hypomania specifically. Aripiprazole, asenapine, carbamazepine, olanzapine, and ziprasidone showed the strongest evidence of efficacy in acute-phase treatment. Quetiapine and divalproex/valproate were also efficacious. Combination therapies with these atypical antipsychotics and mood stabilizers can be considered in severe cases. Olanzapine and quetiapine (alone or in combination with lithium/divalproex) showed the strongest evidence of efficacy in maintenance treatment. Lithium and lamotrigine may be beneficial given their preventive effects on suicide and depressive relapse. Further prospective studies primarily focusing on mixed states are needed.

scholarly journals Treatment of bipolar depression with supraphysiologic doses of levothyroxine: a randomized, placebo-controlled study of comorbid anxiety symptoms

2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Maximilian Pilhatsch ◽  
Thomas J Stamm ◽  
Petra Stahl ◽  
Ute Lewitzka ◽  
Anne Berghöfer ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Phenotypic Expression ◽  
Anxiety Symptoms ◽  
Controlled Study ◽  
Double Blind ◽  
Comorbid Anxiety ◽  
Depressed Patients ◽  
Depressive Episodes

Abstract Background Symptoms of anxiety co-occur in a variety of disorders including in depressive episodes of bipolar disorder and in patients with thyrotoxicosis. Treatment of refractory bipolar disorder with supraphysiologic doses of levothyroxine (L-T4) has been shown to improve the phenotypic expression of the disorder and is associated with an increase of circulating thyroid hormones. However, it might be associated with somatic and mental adverse effects. Here we report the investigation of the influence of treatment with supraphysiologic doses of L-T4 on symptoms of anxiety in patients with refractory bipolar depression. Methods Post-hoc analysis from a 6-week, multi-center, randomized, double-blind, placebo-controlled study of the effects of supraphysiologic L-T4 treatment on anxiety symptoms in bipolar depression. Anxiety symptoms were measured weekly with the Hamilton anxiety/somatization factor (HASF) score of the Hamilton Depression Rating Scale (HAMD) and the State- and Trait Anxiety Inventory (STAI). Results Treatment of both groups was associated with a significant reduction in anxiety symptoms (p < 0.001) with no statistical difference between groups (LT-4: from 5.9 (SD = 2.0) at baseline to 3.7 (SD = 2.4) at study end; placebo: from 6.1 (SD = 2.4) at baseline to 4.4 (SD = 2.8) at study end; p = 0.717). Severity of anxiety at baseline did not show a statistically significant correlation to the antidepressive effect of treatment with supraphysiologic doses of L-T4 (p = 0.811). Gender did not show an influence on the reduction of anxiety symptoms (females: from 5.6 (SD = 1.7) at baseline to 3.5 (SD = 2.4) at study end; males: from 6.1 (SD = 2.3) at baseline to 4.0 (SD = 2.4) at study end; p = 0.877). Conclusions This study failed to detect a difference in change of anxiety between bipolar depressed patients treated with supraphysiologic doses of L-T4 or placebo. Comorbid anxiety symptoms should not be considered a limitation for the administration of supraphysiologic doses of L-T4 refractory bipolar depressed patients. Trial registration ClinicalTrials, ClinicalTrials.gov identifier: NCT01528839. Registered 2 June 2012—Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT01528839

scholarly journals Living With Bipolar Disorder in the Time of Covid-19: Biorhythms During the Severe Lockdown in Cagliari, Italy, and the Moderate Lockdown in Tunis, Tunisia

2021 ◽  
Vol 12 ◽  
Author(s):  
Mauro Giovanni Carta ◽  
Uta Ouali ◽  
Alessandra Perra ◽  
Azza Ben Cheikh Ahmed ◽  
Laura Boe ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Depressive Symptoms ◽  
Rating Scale ◽  
Biological Rhythms ◽  
Short Term ◽  
Female Age ◽  
Future Studies ◽  
Restrictive Measures ◽  
Depressive Episodes ◽  
Hamilton Rating Scale

Background: Restrictions during Covid-19 pandemic lockdown, in which rhythms of life have been compromised, can influence the course of bipolar disorder (BD). This study follows patients with bipolar disorder living in two geographically close cities (Cagliari and Tunis), but with different lockdown conditions: less severe in Tunis.Methods: Two cohorts were evaluated during lockdown (April 2020, t0) and 2 months later with lockdown lifted for a month (t1). Individuals were: over 18 years old without gender exclusion, BD I or II, in care for at least 1 year, received a clinical interview in the month before the start of the lockdown, stable clinically before the lockdown. The assessment was conducted by telephone by a psychiatrist or psychologist with good knowledge of patients. Diagnoses were made according to DSM-5 criteria. Depressive symptoms were collected through the Hamilton Rating Scale for Depression; cut-off 14 indicative of depressive episode. Circadian rhythms were measured using the BRIAN scale.Results: Forty individuals in Cagliari (70%female, age 48.57 ± 11.64) and 30 in Tunis (53.3% Female, age 41.8 ± 13.22) were recruited. In Cagliari at t0 45% had depressive episodes against none in Tunis, a similar difference appeared at t1. At t0 and t1 the Cagliari sample had more dysfunctional scores in the overall BRIAN scale and in the areas of sleep, activities and social rhythms; no differences were found in nutrition, both samples had predominantly nocturnal rhythm. In Cagliari at t0 and t1, the depressive sub-group showed more dysfunctional scores in the BRIAN areas sleep, activity, and nutrition. However, the differences in biological rhythms resulted, through ANCOVA analysis, independent of the co-presence of depressive symptoms.Discussion: A rigid lockdown could expose people with BD to depressive relapse through dysregulation of biological rhythms. The return to more functional rhythms did not appear 1 month after lockdown. The rekindling of the pandemic and the restoration of new restrictive measures will prevent, at least in the short term, the beneficial effect of a return to normality of the two cohorts.This was a limited exploratory study; future studies with larger samples and longer observational time are needed to verify the hypothesis.

Sign in / Sign up

Export Citation Format

Share Document