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 Lovastatin as an Adjuvant to Lithium for Treating Manic Phase of Bipolar Disorder: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Ahmad Ghanizadeh ◽  
Motahhar OmraniSigaroodi ◽  
Ali Javadpour ◽  
Mohammad Hossein Dabbaghmanesh ◽  
Sara Shafiee
Keyword(s):  
Clinical Trial ◽  
Bipolar Disorder ◽  
Placebo Group ◽  
Adverse Effects ◽  
Rating Scale ◽  
Clinical Symptoms ◽  
Controlled Clinical Trial ◽  
Young Mania ◽  
Double Blind ◽  
Significant Difference

Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania.Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked.Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects.Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).

Adjunctive Therapy to Manage Neuropsychiatric Symptoms in Moderate and Severe Dementia: Randomized Clinical Trial Using an Outpatient Version of Tailored Activity Program

2021 ◽  
pp. 1-12
Author(s):  
Alexandra Martini Oliveira ◽  
Marcia Radanovic ◽  
Patricia Cotting Homem de Mello ◽  
Patricia Cardoso Buchain ◽  
Adriana Dias Barbosa Vizzotto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Disturbances ◽  
Rating Scale ◽  
Neuropsychiatric Symptoms ◽  
Caregiver Training ◽  
Controlled Clinical Trial ◽  
Post Intervention ◽  
Double Blind ◽  
Activity Program ◽  
Experimental Group

Background: Neuropsychiatric symptoms (NPS) such as aggression, apathy, agitation, and wandering may occur in up to 90%of dementia cases. International guidelines have suggested that non-pharmacological interventions are as effective as pharmacological treatments, however without the side effects and risks of medications. An occupational therapy method, called Tailored Activity Program (TAP), was developed with the objective to treat NPS in the elderly with dementia and has been shown to be effective. Objective: Evaluate the efficacy of the TAP method (outpatient version) in the treatment of NPS in individuals with dementia and in the burden reduction of their caregivers. Methods: This is a randomized, double-blind, controlled clinical trial for the treatment of NPS in dementia. Outcome measures consisted of assessing the NPS of individuals with dementia, through the Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and assessing the burden on their caregivers, using the Zarit Scale. All the participants were evaluated pre-and post-intervention. Results: 54 individuals with dementia and caregivers were allocated to the experimental (n = 28) and control (n = 26) groups. There was improvement of the following NPS in the experimental group: delusions, agitation, aggressiveness, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, and aberrant vocalization. No improvement was observed in hallucinations, sleep disturbances, and appetite disorders. The TAP method for outpatient settings was also clinically effective in reducing burden between caregivers of the experimental group. Conclusion: The use of personalized prescribed activities, coupled with the caregiver training, may be a clinically effective approach to reduce NPS and caregiver burden of individuals with dementia.

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 Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033815
Author(s):  
Tian-tian Ma ◽  
Zhikai Yang ◽  
Sainan Zhu ◽  
Jing-hong Zhao ◽  
Yi Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peritoneal Dialysis ◽  
Restless Legs Syndrome ◽  
Rating Scale ◽  
Controlled Trial ◽  
Psychological Status ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Restless Legs ◽  
Peking University

IntroductionRestless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD).Methods and analysisThis is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes.Ethics and disseminationThe study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals.Trial registration numberNCT03817554

OscillococcinumR in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation

1998 ◽  
Vol 87 (02) ◽  
pp. 69-76 ◽  
Author(s):  
Rosemarie Papp ◽  
Gert Schuback ◽  
Elmar Beck ◽  
Georg Burkard ◽  
Jürgen Bengel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Rectal Temperature ◽  
Muscle Pain ◽  
Rating Scale ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Number Of Patients ◽  
Positive Effect

AbstractA controlled clinical trial was conducted to assess the effectiveness of OscillococcinumR in the treatment of patients with influenza-like syndromes. 188 patients received the test drug and 184 patients were assigned to the placebo. Data were recorded by the participating physicians at the beginning of the treatment, after 48 hours and after 7–10 days. During the first few days, the patients recorded their rectal temperature twice a day (mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat, muscle pain, etc.), and use of medication. Recovery was defined as follows: ‘rectal temperature < 37.5°C and no headache or muscle pain’. Effectiveness was defined as a statistically significant greater decrease in symptoms after 48 hours in the verum group or a shorter duration of symptoms in comparison to the placebo group. After 48 hours the symptoms of the patients in the verum group were significantly milder (P=0.023) than in the placebo group. The number of patients with no symptoms was significantly higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%) until the end of the patients’ recording (day 5 in the evening: verum: 73.7%, placebo: 67.7%). The biggest group difference was recorded for the time between the evening of the second day (10.6% more patients with no symptoms) and the morning of the fourth day (10.2% more patients with no symptoms). The clinical trial showed that treatment of influenza-like syndromes with OscillococcinumR has a positive effect on the decline of symptoms and on the duration of the disease.

Sign in / Sign up

Export Citation Format

Share Document