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.

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 Reduced Plasma Dopamine-β-Hydroxylase Activity Is Associated With the Severity of Bipolar Disorder: A Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Zuoli Sun ◽  
Qijing Bo ◽  
Zhen Mao ◽  
Feng Li ◽  
Fan He ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Depression Scale ◽  
Hamilton Depression Scale ◽  
Cognitive Assessments ◽  
Young Mania ◽  
Neuropsychological Status ◽  
Patient Health ◽  
Depressive Episodes

Dopamine-β-hydroxylase (DβH) is an enzyme converting dopamine to norepinephrine, a key neurotransmitter in mood disorders, such as major depressive disorder (MDD) and bipolar disorder (BD). Due to overlapping symptomology of unipolar and bipolar depression, the present study attempted to explorer if the plasma DβH activity could discriminate the depressive episodes of BD from MDD. The aim of this study was to compare the plasma DβH activity among MDD patients (n = 104), BD patients (n = 101), and healthy controls (n = 160). Clinical characteristics and cognitive function were assessed using the Young Mania Rating Scale (YMRS), Hamilton Depression Scale (HAM-D), Hamilton Anxiety Scale (HAM-A), Patient Health Questionnaire-9 (PHQ-9), and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Our data showed a lower plasma DβH activity in patients with BD, not MDD, than that in controls. For the BD patients, the plasma DβH activities were negatively correlated with HAM-D scores and HAM-A scores. However, there was no significant correlation between plasma DβH activity and severity of depressive symptoms in MDD patients. No significant correlation between DβH activities and cognitive assessments neither in BD nor in MDD patients. The present study provides evidence that BD is associated with decreased circulating DβH activity.

Clinical differences between unipolar and bipolar depression

2017 ◽  
Vol 41 (S1) ◽  
pp. S428-S428
Author(s):  
S. Smaoui ◽  
N. Charfi ◽  
M. Maâlej Bouali ◽  
L. Zouari ◽  
N. Zouari ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Unipolar Depression ◽  
Total Sample ◽  
Epidemiological Studies ◽  
University Hospital ◽  
Median Score ◽  
Depressed Patients ◽  
Bipolar Patients

IntroductionEpidemiological studies indicate that the majority of patients with bipolar disorder are diagnosed many years later. Unipolar depression represents the most frequent misdiagnosis.ObjectivesThis study aimed to examine the symptom profiles of depressed patients in order to identify clinical specificities of bipolar depression.MethodsA total of 31 depressed patients were recruited from psychiatry outpatient department of Hedi Chaker university hospital in Sfax (Tunisia), during October and November 2016. Unipolar and bipolar patients were compared on a broad range of parameters, including sociodemographic and clinical characteristics. Depressive symptoms were rated using the Montgomery Asberg Depression Rating Scale (MADRS) and Bipolar Depression Rating Scale (BDRS).ResultsThe total sample comprised 31 patients with 16 men and 15 women. It involved 20 with unipolar depression and 11 with bipolar depression. Patients with bipolar depression had more family history of bipolar disorder (P = 0.037) and a triggering factor had been identified less often (P = 0.03). MADRS scores were similar in bipolar and unipolar patient (median score 28.22 versus 28.36; P = 0.964). BDRS scores were significantly higher in bipolar depressed patients (median score 33 versus 25; P = 0.01). The mixed subscale (item 16 to 20) scores were particularly higher (median 6 vs. 1.2; P ≤ 0.01) especially concerning irritability (P = 0.001). Increased motor drive (P = 0.004) and agitation (P = 0.008).ConclusionOur findings suggest that the presence of mixed symptoms is very important to recognize depressed patients as having a bipolar disorder. We also recommend routine use of the BDRS for patients presenting for treatment of depression.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Randomised, double-blind, placebo-controlled study of olanzapine in patients with bipolar I depression

2012 ◽  
Vol 201 (5) ◽  
pp. 376-382 ◽  
Author(s):  
Mauricio Tohen ◽  
David P. McDonnell ◽  
Michael Case ◽  
Shigenobu Kanba ◽  
Kyooseob Ha ◽  
...  
Keyword(s):  
Atypical Antipsychotics ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Controlled Study ◽  
Young Mania ◽  
Double Blind ◽  
End Point ◽  
Hamilton Rating Scale ◽  
Rate Of Response

BackgroundAtypical antipsychotics are widely used in bipolar mania. However, the efficacy of atypical antipsychotics in bipolar depression has not been comprehensively explored.AimsTo evaluate olanzapine monotherapy in patients with bipolar depression.MethodPatients with bipolar depression received olanzapine (5–20mg/day, n = 343) or placebo (n = l71) for 6 weeks. The primary outcome was change from baseline to end-point in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Secondary outcomes included: Clinical Global impression - Bipolar Version (CGI-BP) scale, 17-item Hamilton Rating Scale for Depression (HRSD-17) and Young Mania Rating Scale (YMRS) scores, and the rate of response (≥50% reduction in MADRS at end-point), recovery (MADRS ≤12 for ≥4 weeks plus treatment completion) and remission (MADRS ≤8). The trial was registered with ClinicalTrials.gov (NCT00510146).ResultsOlanzapine demonstrated: significantly greater (P<0.04) improvements on MADRS (least-squares mean change -13.82 v. -11.67), HRSD-17 and YMRS total scores and all CGI-BP subscale scores v. placebo; significantly (P≤0.05) more response and remission, but not recovery; significantly (P<0.01) greater mean increases in weight, fasting cholesterol and triglycerides; and significantly more (P<0.001) patients gained ≥7% body weight.ConclusionsOlanzapine monotherapy appears to be efficacious in bipolar depression. Additional long-term studies are warranted to confirm these results. Safety findings were consistent with the known safety profile of olanzapine.

scholarly journals The use of atypical antipsychotics in the therapy of depressive episodes in patients with bipolar disorder

2021 ◽  
Vol 12 (3) ◽  
pp. 32-35
Author(s):  
E. A. Strel’tsov
Keyword(s):  
Bipolar Disorder ◽  
Literature Search ◽  
Atypical Antipsychotics ◽  
Web Of Science ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Systematic Literature Search ◽  
Severity Scale ◽  
Meta Analyses ◽  
Depressive Episodes

This literature review addresses the effi cacy and safety of atypical antipsychotics in patients with bipolar depression. Th e results of randomized studies and systematic meta-analyses of recent years were revised in detail. The effi cacy of the drug intake was reviewed for the following key research points: Clinical General Impression of Condition Severity Scale (CGI-S) and Montgomery-Asberg Depression Rating Scale (MADRS). A systematic literature search was carried out using Scopus, Web of Science, MedLine, elibrary, and other databases.

Modulation of Remifentanil-induced Analgesia and Postinfusion Hyperalgesia by Parecoxib in Humans

2006 ◽  
Vol 105 (5) ◽  
pp. 1016-1023 ◽  
Author(s):  
Andreas Tröster ◽  
Ruth Sittl ◽  
Boris Singler ◽  
Martin Schmelz ◽  
Jürgen Schüttler ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Rating Scale ◽  
Control Level ◽  
Numeric Rating Scale ◽  
Cyclooxygenase 2 ◽  
Controlled Study ◽  
Double Blind ◽  
Antinociceptive Effects ◽  
Current Densities ◽  
Mu Opioids

Background Numerous experimental and clinical studies suggest that brief opioid exposure can enhance pain sensitivity. It is suggested that spinal cyclooxygenase activity may contribute to the development and expression of opioid tolerance. The aim of the investigation was to determine analgesic and antihyperalgesic properties of the cyclooxygenase-2 inhibitor parecoxib on remifentanil-induced hypersensitivity in humans. Methods Fifteen healthy male volunteers were enrolled in this randomized, double-blind, placebo-controlled study in a crossover design. Transcutaneous electrical stimulation at high current densities was used to induce spontaneous acute pain (numeric rating scale 6 of 10) and stable areas of pinprick hyperalgesia. Pain intensities and areas of hyperalgesia were assessed before, during, and after a 30-min intravenous infusion of remifentanil (0.1 microg x kg x min) or placebo (saline). Parecoxib (40 mg) was administered intravenously either with onset of electrical stimulation (preventive) or in parallel to the remifentanil infusion. Results Remifentanil reduced pain and mechanical hyperalgesia during the infusion, but upon withdrawal, pain and hyperalgesia increased significantly above control level. Preventive administration of parecoxib led to an amplification of remifentanil-induced antinociceptive effects during the infusion (71.3 +/- 7 vs. 46.4 +/- 17% of control) and significantly diminished the hyperalgesic response after withdrawal. In contrast, parallel administration of parecoxib did not show any modulatory effects on remifentanil-induced hyperalgesia. Conclusion The results confirm clinically relevant interaction of mu opioids and prostaglandins in humans. Adequate timing seems to be of particular importance for the antihyperalgesic effect of cyclooxygenase-2 inhibitors.

scholarly journals Age at onset, course of illness and response to psychotherapy in bipolar disorder: results from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

2014 ◽  
Vol 44 (16) ◽  
pp. 3455-3467 ◽  
Author(s):  
A. Peters ◽  
L. G. Sylvia ◽  
P. V. da Silva Magalhães ◽  
D. J. Miklowitz ◽  
E. Frank ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Collaborative Care ◽  
Bipolar Depression ◽  
Age At Onset ◽  
Number Needed To Treat ◽  
Systematic Treatment ◽  
Illness Duration ◽  
Bipolar Patients ◽  
Depressive Episodes ◽  
Intensive Psychotherapy

Background.The course of bipolar disorder progressively worsens in some patients. Although responses to pharmacotherapy appear to diminish with greater chronicity, less is known about whether patients' prior courses of illness are related to responses to psychotherapy.Method.Embedded in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) was a randomized controlled trial of psychotherapy for bipolar depression comparing the efficacy of intensive psychotherapy with collaborative care (a three-session psycho-educational intervention). We assessed whether the number of previous mood episodes, age of illness onset, and illness duration predicted or moderated the likelihood of recovery and time until recovery from a depressive episode in patients in the two treatments.Results.Independently of treatment condition, participants with one to nine prior depressive episodes were more likely to recover and had faster time to recovery than those with 20 or more prior depressive episodes. Participants with fewer than 20 prior manic episodes had faster time to recovery than those with 20 or more episodes. Longer illness duration predicted a longer time to recovery. Participants were more likely to recover in intensive psychotherapy than collaborative care if they had 10–20 prior episodes of depression [number needed to treat (NNT) = 2.0], but equally likely to respond to psychotherapy and collaborative care if they had one to nine (NNT = 32.0) or >20 (NNT = 9.0) depressive episodes.Conclusions.Number of previous mood episodes and illness duration are associated with the likelihood and speed of recovery among bipolar patients receiving psychosocial treatments for depression.

scholarly journals Perioperative pregabalin for reducing pain, analgesic consumption, and anxiety and enhancing sleep quality in elective neurosurgical patients: a prospective, randomized, double-blind, and controlled clinical study

2016 ◽  
Vol 125 (6) ◽  
pp. 1513-1522 ◽  
Author(s):  
Nir Shimony ◽  
Uri Amit ◽  
Bella Minz ◽  
Rachel Grossman ◽  
Marc A. Dany ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Sleep Quality ◽  
Rating Scale ◽  
Preoperative Anxiety ◽  
Controlled Study ◽  
Double Blind ◽  
Analgesic Consumption ◽  
Pain Scores ◽  
Neurosurgical Patients ◽  
Duration Of Surgery

OBJECTIVE The aim of this study was to assess in-hospital (immediate) postoperative pain scores and analgesic consumption (primary goals) and preoperative anxiety and sleep quality (secondary goals) in patients who underwent craniotomy and were treated with pregabalin (PGL). Whenever possible, out-of-hospital pain scores and analgesics usage data were obtained as well. METHODS This prospective, randomized, double-blind and controlled study was conducted in consenting patients who underwent elective craniotomy for brain tumor resection at Tel Aviv Medical Center between 2012 and 2014. Patients received either 150 mg PGL (n = 50) or 500 mg starch (placebo; n = 50) on the evening before surgery, 1.5 hours before surgery, and twice daily for 72 hours following surgery. All patients spent the night before surgery in the hospital, and no other premedication was administered. Opioids and nonsteroidal antiinflammatory drugs were used for pain, which was self-rated by means of a numerical rating scale (score range 0–10). RESULTS Eighty-eight patients completed the study. Data on the American Society of Anesthesiologists class, age, body weight, duration of surgery, and intraoperative drugs were similar for both groups. The pain scores during postoperative Days 0 to 2 were significantly lower in the PGL group than in the placebo group (p < 0.01). Analgesic consumption was also lower in the PGL group, both immediately and 1 month after surgery. There were fewer requests for antiemetics in the PGL group, and the rate of postoperative nausea and vomiting was lower. The preoperative anxiety level and the quality of sleep were significantly better in the PGL group (p < 0.01). There were no PGL-associated major adverse events. CONCLUSIONS Perioperative use of twice-daily 150 mg pregabalin attenuates preoperative anxiety, improves sleep quality, and reduces postoperative pain scores and analgesic usage without increasing the rate of adverse effects. Clinical trial registration no.: NCT01612832 (clinicaltrials.gov)

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