Cognitive outcomes of the bipolar depression electrical treatment trial (BETTER): a randomized, double-blind, sham-controlled study

2020 ◽  
Author(s):  
Gabriel Tortella ◽  
Bernardo Sampaio-Junior ◽  
Marina L. Moreno ◽  
Adriano H. Moffa ◽  
Adriano Fernandes da Silva ◽  
...  
Keyword(s):  
Bipolar Depression ◽  
Cognitive Outcomes ◽  
Controlled Study ◽  
Treatment Trial ◽  
Double Blind ◽  
Electrical Treatment

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 Efficacy of ethyl-eicosapentaenoic acid in bipolar depression: Randomised double-blind placebo-controlled study

2006 ◽  
Vol 188 (1) ◽  
pp. 46-50 ◽  
Author(s):  
Sophia Frangou ◽  
Michael Lewis ◽  
Paul McCrone
Keyword(s):  
Eicosapentaenoic Acid ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Unipolar Depression ◽  
Adjunctive Treatment ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Double Blind Study ◽  
Young Mania ◽  
Double Blind

BackgroundEpidemiological and clinical studies suggest that increased intake of eicosapentaenoic acid (EPA) alleviates unipolar depression.AimsTo examine the efficacy of EPA in treating depression in bipolar disorder.MethodIn a 12-week, double-blind study individuals with bipolar depression were randomly assigned to adjunctive treatment with placebo (n=26) or with 1g/day (n=24) or 2 g/day (n=25) of ethyl-EPA. Primary efficacy was assessed by the Hamilton Rating Scale for Depression (HRSD), with changes in the Young Mania Rating Scale and Clinical Global Impression Scale (CGI) as secondary outcome measures.ResultsThere was no apparent benefit of 2g over 1g ethyl-EPA daily. Significant improvement was noted with ethyl-EPA treatment compared with placebo in the HRSD (P=0.04) and the CGI (P=0.004) scores. Both doses were well tolerated.ConclusionsAdjunctive ethyl-EPA is an effective and well-tolerated intervention in bipolar depression.

A Double-Blind, Placebo-Controlled Study of Quetiapine and Lithium Monotherapy in Adults in the Acute Phase of Bipolar Depression (EMBOLDEN I)

2010 ◽  
Vol 71 (02) ◽  
pp. 150-162 ◽  
Author(s):  
Allan H. Young ◽  
Susan L. McElroy ◽  
Michael Bauer ◽  
Nabil Philips ◽  
William Chang ◽  
...  
Keyword(s):  
Acute Phase ◽  
Bipolar Depression ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

A Double-Blind, Randomized, Placebo-Controlled Study of Aspirin and N-Acetylcysteine as Adjunctive Treatments for Bipolar Depression

2018 ◽  
Vol 80 (1) ◽  
Author(s):  
Isabelle E. Bauer ◽  
Charles Green ◽  
Gabriela D. Colpo ◽  
Antonio L. Teixeira ◽  
Sudhakar Selvaraj ◽  
...  
Keyword(s):  
Bipolar Depression ◽  
Controlled Study ◽  
Double Blind

A Double-Blind, Placebo-Controlled Study of Quetiapine and Paroxetine as Monotherapy in Adults With Bipolar Depression (EMBOLDEN II)

2010 ◽  
Vol 71 (02) ◽  
pp. 163-174 ◽  
Author(s):  
Susan L. McElroy ◽  
Richard H. Weisler ◽  
William Chang ◽  
Bengt Olausson ◽  
Björn Paulsson ◽  
...  
Keyword(s):  
Bipolar Depression ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals The Acute and Chronic Cognitive Effects of a Sage Extract: A Randomized, Placebo Controlled Study in Healthy Humans

Nutrients ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 218
Author(s):  
Emma L. Wightman ◽  
Philippa A. Jackson ◽  
Bethany Spittlehouse ◽  
Thomas Heffernan ◽  
Damien Guillemet ◽  
...  
Keyword(s):  
Working Memory ◽  
Brain Function ◽  
Cognitive Outcomes ◽  
Controlled Study ◽  
Post Dose ◽  
Double Blind ◽  
Healthy Humans ◽  
The Impact

The sage (Salvia) plant contains a host of terpenes and phenolics which interact with mechanisms pertinent to brain function and improve aspects of cognitive performance. However, previous studies in humans have looked at these phytochemicals in isolation and following acute consumption only. A preclinical in vivo study in rodents, however, has demonstrated improved cognitive outcomes following 2-week consumption of CogniviaTM, a proprietary extract of both Salvia officinalis polyphenols and Salvia lavandulaefolia terpenoids, suggesting that a combination of phytochemicals from sage might be more efficacious over a longer period of time. The current study investigated the impact of this sage combination on cognitive functions in humans with acute and chronic outcomes. Participants (n = 94, 25 M, 69 F, 30–60 years old) took part in this randomised, double-blind, placebo-controlled, parallel groups design where a comprehensive array of cognitions were assessed 120- and 240-min post-dose acutely and following 29-day supplementation with either 600 mg of the sage combination or placebo. A consistent, significant benefit of the sage combination was observed throughout working memory and accuracy task outcome measures (specifically on the Corsi Blocks, Numeric Working Memory, and Name to Face Recall tasks) both acutely (i.e., changes within day 1 and day 29) and chronically (i.e., changes between day 1 to day 29). These results fall slightly outside of those reported previously with single Salvia administration, and therefore, a follow-up study with the single and combined extracts is required to confirm how these effects differ within the same cohort.

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