scholarly journals Agomelatine or placebo as adjunctive therapy to a mood stabiliser in bipolar I depression: Randomised double-blind placebo-controlled trial

2016 ◽  
Vol 208 (1) ◽  
pp. 78-86 ◽  
Author(s):  
Lakshmi N. Yatham ◽  
Eduard Vieta ◽  
Guy M. Goodwin ◽  
Michel Bourin ◽  
Christian de Bodinat ◽  
...  
Keyword(s):  
Adjunctive Therapy ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Controlled Trial ◽  
Acute Therapy ◽  
Double Blind ◽  
Continuation Therapy ◽  
Primary Efficacy Measure ◽  
Scale Scores ◽  
Efficacy Measure

BackgroundAdjunctive antidepressant therapy is commonly used to treat acute bipolar depression but few studies have examined this strategy.AimsTo examine the efficacy of agomelatine v. placebo as adjuncts to lithium or valproate in bipolar depression.MethodPatients who were currently depressed despite taking lithium or valproate for at least 6 weeks were randomised to treatment with agomelatine (n = 172) or placebo (n = 172) for 8 weeks of acute therapy and 44 weeks of continuation therapy (trial registration: ISRCTN28588282).ResultsNo significant differences in improvement of depressive symptoms were observed between the two groups either at 8 weeks or 52 weeks on the primary efficacy measure of change in Montgomery–Åsberg Depression Rating Scale scores from baseline to end-point. Adverse events including switches into mania/hypomania were low and similar in both groups.ConclusionsAgomelatine adjunctive therapy was not superior to placebo adjunctive therapy for acute bipolar depression.

scholarly journals Levodopa+carbidopa in X-linked Dystonia Parkinsonism (XDP/DYT3/Lubag): A Randomized, Double-blind, Placebo-controlled Trial

2018 ◽  
Vol 52 (6) ◽  
Author(s):  
Roland Dominic G. Jamora ◽  
Rosalia A. Teleg ◽  
Cynthia P. Cordero ◽  
Rodelyn F. Villareal-Jordan ◽  
Lillian V. Lee ◽  
...  
Keyword(s):  
Rating Scale ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Intention To Treat ◽  
Oral Medications ◽  
Significant Difference ◽  
Scale Scores

Objective. X-linked dystonia parkinsonism (XDP) is an adult-onset, progressive and debilitating movement disorder described among Filipino males from Panay Island. The available oral medications have been ineffective. While chemodenervation with botulinum toxin A works and deep brain stimulation surgery is promising, these are not affordable for the vast majority of patients. Thus, we decided to look into the efficacy, safety and tolerability of levodopa+carbidopa (levodopa) versus placebo among patients with XDP. Methods. This was a double blind, randomized, placebo-controlled clinical trial. Patients were randomized to receive levodopa or placebo for 6 months. The dose was increased gradually until 1000 mg levodopa/day is reached or until side effects appear. Results. A total of 86 out of 94 randomized patients (91.5%) were included in the intention-to-treat cohort for the primary efficacy analysis. Nineteen patients (9 in levodopa, 10 in placebo) dropped out or were lost to follow up. There was no significant difference in the baseline and last visit Burke Fahn Marsden Dystonia Rating Scale and the part III of the Unified Parkinson’s Disease Rating Scale scores between levodopa and placebo. The most common adverse events in the levodopa group were increased movements, pain and nausea/ vomiting. Conclusion. While levodopa is safe and well-tolerated, it does not have any effect in alleviating the dystonia or parkinsonism in XDP

Continuing treatment of panic disorder after acute response: randomised, placebo-controlled trial with fluoxetine

1999 ◽  
Vol 174 (3) ◽  
pp. 213-218 ◽  
Author(s):  
David Michelson ◽  
Mark Pollack ◽  
R. Bruce Lydiard ◽  
Roy Tamura ◽  
Rosalinda Tepner ◽  
...  
Keyword(s):  
Panic Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Initial Response ◽  
Attack Frequency ◽  
Acute Therapy ◽  
Acute Response ◽  
Continuation Therapy ◽  
Fluoxetine Treatment ◽  
Appropriate Treatment

BackgroundData concerning appropriate treatment in panic disorder following an initial response to acute therapy are limited.AimsTo assess the safety and efficacy of continued fluoxetine treatment following successful acute therapy of panic disorder.MethodPatients who responded to acute fluoxetine treatment were randomised to 24 weeks of continued fluoxetine or placebo.ResultsFluoxetine responders randomised to continue on their acute-phase fluoxetine dose experienced statistically significant improvement in panic attack frequency and phobia rating scale score over 24 weeks of therapy, while those switched to placebo experienced statistically significant worsening in Hamilton Anxiety (HAM–A), Hamilton Depression (HAM–D) and SCL–90–R rating scores.ConclusionsFluoxetine was associated with improved clinical outcomes compared with placebo during continuation therapy.

Agomelatine in the treatment of obsesive-compulsive-disorder: Potential for clinical effectiveness: An 4-week, multicenter, randomized, placebo-controlled trial

2011 ◽  
Vol 26 (S2) ◽  
pp. 974-974 ◽  
Author(s):  
P. Marqués Cabezas ◽  
G. Cabus Piñol ◽  
J. Coullaut-Valera García ◽  
C. Dominguez Martín ◽  
J.L. Villegas Martinez
Keyword(s):  
Clinical Response ◽  
Rating Scale ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Fixed Dose ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
Efficacy Measure

ObjectiveTo evaluate the efficacy, safety, and tolerability of fixed-dose agomelatine 25 and 50 mg/d in the treatment of outpatients with obsesive-compulsive disorder (OCD) compared to placebo.MethodIn this 8-week, multicenter, double-blind, parallel-group trial, patients with DSM-IV-defined OCD were randomly assigned (1:1:1) to receive a once-daily dose of agomelatine 25 mg, agomelatine 50 mg, or placebo. The primary efficacy measure was the change from baseline to week 8 in the clinician-rated 17-item Hamilton Depression Rating Scale (HDRS(17)); other efficacy measures were The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Clinical Global Impression scale. The study was conducted between December 2009 and January 2010.ResultsAgomelatine 25 mg/d was more efficacious based on the HDRS(17) total score (P = .01) compared to placebo throughout the treatment period, whereas for agomelatine 50 mg/d, statistically significant reduction in HDRS(17) total score could be observed from weeks 2 to 6 but not at week 8 (P = .144). A higher proportion of patients receiving agomelatine 25 mg/d showed clinical response (P = .013), clinical remission (P = .07), and improvement according to the Clinical Global Impressions-Improvement scale (P = .065) compared to those receiving placebo. No statistically significant difference between patients receiving agomelatine 50 mg/d compared to placebo on clinical response. Both agomelatine doses were safe and well tolerated, although clinically notable aminotransferase elevations were observed transiently in the agomelatine 50 mg/d group.ConclusionsAgomelatine 50 mg/d provided evidence for its antidepressant efficacy until week 6 and was also safe and well tolerated.

scholarly journals The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder

2010 ◽  
Vol 22 (5) ◽  
pp. 237-242 ◽  
Author(s):  
Michael Berk ◽  
Seetal Dodd ◽  
Olivia M Dean ◽  
Kristy Kohlmann ◽  
Lesley Berk ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bipolar Disorder ◽  
Internal Structure ◽  
Adjunctive Therapy ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Rating Scale Data ◽  
Scale Data

Berk M, Dodd S, Dean OM, Kohlmann K, Berk L, Malhi GS. The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder.Background:The phenomenology of unipolar and bipolar disorders differ in a number of ways, such as the presence of mixed states and atypical features. Conventional depression rating instruments are designed to capture the characteristics of unipolar depression and have limitations in capturing the breadth of bipolar disorder.MethodThe Bipolar Depression Rating Scale (BDRS) was administered together with the Montgomery Asberg Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) in a double-blind randomised placebo-controlled clinical trial of N-acetyl cysteine for bipolar disorder (N = 75).Results:A factor analysis showed a two-factor solution: depression and mixed symptom clusters. The BDRS has strong internal consistency (Cronbach's alpha = 0.917), the depression cluster showed robust correlation with the MADRS (r = 0.865) and the mixed subscale correlated with the YMRS (r = 0.750).Conclusion:The BDRS has good internal validity and inter-rater reliability and is sensitive to change in the context of a clinical trial.

scholarly journals Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study

2008 ◽  
Vol 193 (6) ◽  
pp. 485-492 ◽  
Author(s):  
S. Charles Schulz ◽  
Mary C. Zanarini ◽  
Anthony Bateman ◽  
Martin Bohus ◽  
Holland C. Detke ◽  
...  
Keyword(s):  
Borderline Personality Disorder ◽  
Personality Disorder ◽  
Rating Scale ◽  
Borderline Personality ◽  
Controlled Study ◽  
Double Blind ◽  
Point Change ◽  
End Point ◽  
Primary Efficacy Measure ◽  
Efficacy Measure

BackgroundDespite the prevalence and clinical significance of borderline personality disorder, its treatment remains understudied.AimsTo evaluate treatment with variably dosed olanzapine in individuals with borderline personality disorder.MethodIn this 12-week randomised, double-blind trial, individuals received olanzapine (2.5–20 mg/day; n=155) or placebo (n=159) (trial registry: NCT00091650). The primary efficacy measure was baseline to end-point change on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN–BPD) using last-observation-carried-forward methodology.ResultsBoth olanzapine and placebo groups showed significant improvements but did not differ in magnitude at end-point (76.56 v. 76.25, P=0.661). Response rates (50% reduction in ZAN–BPD) were 64.7% with olanzapine and 53.5% with placebo (P=0.062); however, time to response was significantly shorter for olanzapine (P=0.022). Weight gain was significantly greater (2.86 v. 70.35 kg, P50.001), with higher incidence of treatment-emergent abnormal high levels of prolactin for the olanzapine group.ConclusionsIndividuals treated with olanzapine and placebo showed significant but not statistically different improvements on overall symptoms of borderline personality disorder. The types of adverse events observed with olanzapine treatment appeared similar to those observed previously in adult populations.

scholarly journals Participant Characteristics as Modifiers of Response to N-Acetyl Cysteine (NAC) in Obsessive-Compulsive Disorder

2016 ◽  
Vol 4 (6) ◽  
pp. 1104-1111 ◽  
Author(s):  
Jerome Sarris ◽  
Georgina Oliver ◽  
David A. Camfield ◽  
Olivia M. Dean
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Study Endpoint ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Modifying Factors ◽  
Scale Scores ◽  
Acetyl Cysteine

We previously reported on a 16-week, double-blind, randomized placebo-controlled trial (RCT) using 3 grams per day of N-acetyl cysteine (NAC) (1.5 grams twice per day) in 44 participants (aged 18–70) with DSM-5-diagnosed obsessive-compulsive disorder (OCD). We now report on an analysis of age, severity and duration of illness, OCD presentation type, baseline anxiety and depression scores, as well as the use of antidepressant medications as potentially modifying factors. Results revealed a significant effect ( p = .037) for younger participants (under mean age of 34) responding to NAC. This remained significant using OCD severity as a covariate ( p = .044). For those under 34 years of age with less than 17 years of OCD duration, this was also significant ( p = .037). Regression analysis within the NAC treatment group also revealed that duration of OCD presentation was a significant predictor of Yale-Brown Obsessive Compulsive Scale (YBOCS) change at study endpoint ( p = .019), whereas baseline Montgomery–Asberg Depression Rating Scale scores were also a trend-level predictor ( p = .060) of YBOCS change in the NAC group.

scholarly journals A Double-Blind Pilot Dosing Study of Low Field Magnetic Stimulation (LFMS) for Treatment-Resistant Depression (TRD)

2018 ◽  
Author(s):  
Marc J. Dubin ◽  
Irena Ilieva ◽  
Zhi-De Deng ◽  
Jeena Thomas ◽  
Ashly Cochran ◽  
...  
Keyword(s):  
Magnetic Stimulation ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Controlled Trial ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Double Blind ◽  
The Third ◽  
Low Field ◽  
Resistant Depression

AbstractLow Field Magnetic Stimulation is a potentially rapid-acting treatment for depression with mood-enhancing effects in as little as one 20-minute session. The most convincing data for LFMS has come from treating bipolar depression. We examined whether LFMS also has rapid mood-enhancing effects in treatment-resistant major depressive disorder, and whether these effects are dose-dependent. We hypothesized that a single 20-min session of LFMS would reduce depressive symptom severity and that the magnitude of this change would be greater after three 20-min sessions than after a single 20-min session. In a double-blind randomized controlled trial, 30 participants (age 21–65) with treatment-resistant depression were randomized to three 20-minute active or sham LFMS treatments with 48 hours between treatments. Response was assessed immediately following LFMS treatment using the 6-item Hamilton Depression Rating Scale (HAMD-6), the Positive and Negative Affect Scale (PANAS) and the Visual Analog Scale. Following the third session of LFMS, the effect of LFMS on VAS and HAMD-6 was superior to sham (F(1, 24) = 7.45, p = 0.03, Holm-Bonferroni corrected; F(1,22) = 6.92, p = 0.03, Holm-Bonferroni corrected, respectively). There were no differences between sham and LFMS following the initial or second session with the effect not becoming significant until after the third session. Three 20-minute LFMS sessions were required for active LFMS to have a mood-enhancing effect for individuals with treatment-resistant depression. As this effect may be transient, future work should address dosing schedules of longer treatment course as well as biomarker-based targeting of LFMS to optimize patient selection and treatment outcomes.

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 Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

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