Improvement of Negative Symptoms in Schizophrenia: A Doubleblind Clinical Trial by Escitalopram in Male Patients

2020 ◽  
Vol 9 (3) ◽  
pp. 211-217
Author(s):  
Saeed S. Shafti
Keyword(s):  
Negative Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Psychiatric Rehabilitation ◽  
Depression Scale ◽  
Primary Outcome Measure ◽  
Neuronal Uptake ◽  
Hamilton Depression Scale ◽  
Male Patients ◽  
The Mean

Background: The negative symptoms of schizophrenia remain a major clinical trouble against psychiatric rehabilitation and available therapeutic treatments. Objective: Escitalopram is known as the most selective SSRI with minimal effects on norepinephrine and dopamine neuronal uptake. The aim of the present study is to assess the effect of escitalopram on negative symptoms of schizophrenia. Methods: This study was an eight-week, randomized, placebo-controlled trial of escitalopram set against placebo, as an add-on medication, in the treatment of 50 patients with a diagnosis of schizophrenia. While the Scale for Assessment of Negative Symptoms was used as the primary outcome measure, the Scale for Assessment of Positive Symptoms, the Simpson-Angus Scale and the Hamilton Depression Scale, as well, were used as a secondary measure for evaluation of positive, extrapyramidal and depressive symptoms, respectively. Results: The primary outcome of the present assessment was a significant reduction in the mean total score of the Scale for Assessment of Negative Symptoms (SANS) in the target group, compared to placebo, at the end of eight weeks. In this regard, most of the subscales of SANS, as well, demonstrated significant improvements by escitalopram. Conclusion: According to the findings, escitalopram can be helpful, as add-on medication, in amelioration of negative symptoms of schizophrenia.

The Ham D6 is more homogenous and as sensitive as the Ham D17

2007 ◽  
Vol 22 (4) ◽  
pp. 252-255 ◽  
Author(s):  
Y. Lecrubier ◽  
P. Bech
Keyword(s):  
Effect Size ◽  
Controlled Trial ◽  
Depression Scale ◽  
Primary Outcome Measure ◽  
Antidepressant Effect ◽  
Hamilton Depression Scale ◽  
Recurrent Depression ◽  
Double Blind ◽  
Specificity And Sensitivity ◽  
Pre Treatment

AbstractObjectiveUsing the data of a positive d.b.c.t. comparing an hypericum extract (W55570) to placebo in depressed patients we explored whether the Ham D6 was unidimentional and in case of a positive answer whether the total score was as sensitive as the total score of the Ham D17.MethodsThe study was a 6 weeks double blind placebo controlled trial comparing 300 mg of hypericum t.i.d (n = 186), to placebo (n = 189), in patients with a single or recurrent depression according to DSM-IV. Superiority of hypericum versus placebo on the main outcome criterion (HDRS 17) was already published.The unidimensionality of the Hamilton depression scale 6 and 17 items were tested using a Mokken scale analysis. The effect size according to the initial severity of depression was calculated on the ITT last observation carried forward population.ResultsThe Ham D6, covering the core symptoms of depression was unidimensional, implying that improving this score reflects a true antidepressant effect. The Ham D17 was not unidimensional.Hypericum was an effective antidepressant in patients with a pre-treatment score of 12 or more (n = 208) on the Ham D6, the effect size was 0.46. No difference with placebo was observed for those with a score of less than 12 (n = 167).ConclusionsFor the evaluation of an antidepressant effect, because of its specificity and sensitivity, the Ham D6 should be used as a primary outcome measure rather than the Ham D17.

scholarly journals A Randomized Controlled Trial of Four Precolonoscopy Bowel Cleansing Regimens

2011 ◽  
Vol 25 (12) ◽  
pp. 657-662 ◽  
Author(s):  
Dina Kao ◽  
Eoin Lalor ◽  
Gurpal Sandha ◽  
Richard N Fedorak ◽  
Bloeme van der Knoop ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Short Interval ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Bowel Cleansing ◽  
The Mean ◽  
Clinically Significant ◽  
The Ideal

BACKGROUND: The ideal bowel cleansing regimen for colonoscopy has yet to be determined.OBJECTIVE: To compare the cleansing efficacy, and patient tolerability and safety of four bowel preparation regimens.METHODS: A total of 834 patients undergoing outpatient colonoscopy were randomly assigned to one of four regimens: 4 L polyethylene glycol (PEG); 2 L PEG + 20 mg bisacodyl; 90 mL of sodium phosphate (NaP); or two sachets of a commercially available bowel cleansing solution (PSMC) + 300 mL of magnesium citrate (M). The primary outcome measure was cleansing efficacy, which was scored by blinded endoscopists using the Ottawa Bowel Preparation Scale. Secondary outcome measures were bowel preparation quality according to time of colonoscopy, and patient tolerability and safety.RESULTS: The mean total cleansing score was significantly worse in the NaP group compared with the other three groups (P<0.0001). The mean cleansing scores were worse in patients who underwent morning versus afternoon colonoscopy, a finding that was consistent in all four groups. PSMC + M was the best tolerated regimen. No clinically significant mean changes in creatinine or electrolyte levels were identified, although a significantly higher proportion of patients in the NaP group developed hypokelemia (P<0.0001).CONCLUSIONS: 2 L PEG + 20 mg bisacodyl, or PSMC + M was as efficacious as 4 L PEG and superior to NaP for bowel cleansing. A short interval between the completion of bowel preparation and the start of colonoscopy (ie, ‘runway time’), irrespective of bowel preparation regimen, appeared to be a more important predictor of bowel cleanliness than the cathartic agents used.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

scholarly journals Retrospective analysis of misdiagnosis of cytomegalovirus retinitis

2020 ◽  
Author(s):  
Kuifang Du ◽  
Xiaojie Huang ◽  
Chao Chen ◽  
Kong Wenjun ◽  
Lianyong Xie ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Low Vision ◽  
Young Male ◽  
Primary Outcome Measure ◽  
Cytomegalovirus Retinitis ◽  
Ischemic Optic Neuropathy ◽  
Irreversible Loss ◽  
Vein Occlusion ◽  
Male Patients ◽  
Systemic Symptoms

Abstract Background Initial misdiagnosis of cytomegalovirus retinitis (CMVR) may lead to irreversible loss of vision and systemic deterioration. We retrospectively reported some misdiagnosis related to CMVR. Methods The medical records of 92 consecutive patients diagnosed or misdiagnosed as CMVR were reviewed retrospectively at the ophthalmology department of Beijing youan hospital from July 2017 to October 2019. The primary outcome measure was to evaluate cases with CMVR who were initially misdiagnosed or who were misdiagnosed as CMVR. Results In 8 (8.7%) out of the 92 patients, the initial diagnosis was incorrect. The median age of the eight patients was 37.5 years (range 20-46 yeas). All (7/7, 100%) patients were male. Patients with CMVR were initially misdiagnosed as diabetic retinopathy (1/92,1.1%), branch retinal vein occlusion (1/92,1.1%), ischemic optic neuropathy (1/92,1.1%), Behcet′s disease (1/92,1.1%), iridocyclitis (2/92, 2.3%), and progressive outer retinal necrosis (1/92,1.1%). One patient with binocular renal retinopathy and chronic renal insufficiency was misdiagnosed as CMVR (1/92,1.1%). All patients presented binocular involvement (sixteen eyes), and two patients (four eyes) presented pan-retinal involvement. Fourteen eyes (14/16, 87.5%) had optic disc or macular area involved. One patient is blind, and two patients had a low vision when the diagnosis is finally clear. Five patients had systemic symptoms. Seven patients were finally diagnosed with AIDS showing an extremely low level of CD4 + T lymphocyte: median of 5 cells/ul (range 1-9 cells/ul). Conclusion The misdiagnosis of CMVR can occur in young male patients. The ophthalmologist should pay more attention to CMVR and systemic symptoms insulting to avoid deterioration of vision and delaying in the management of systemic conditions.

A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

1995 ◽  
Vol 1 (2) ◽  
pp. 118-135 ◽  
Author(s):  
LD Jacobs ◽  
DL Cookfair ◽  
RA Rudick ◽  
RM Herndon ◽  
J R Richert ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Interferon Beta ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Recombinant Interferon ◽  
Study Population ◽  
The Mean ◽  
Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

Primary Use of the TruePath Crossing Device for Infrainguinal Chronic Total Occlusions With Intravascular Ultrasound Evaluation

2018 ◽  
Vol 25 (5) ◽  
pp. 592-598 ◽  
Author(s):  
Yoshimitsu Soga ◽  
Miho Nakamura ◽  
Kaoru Hirose ◽  
Nobuhiro Ito ◽  
Yusuke Tomoi ◽  
...  
Keyword(s):  
Intravascular Ultrasound ◽  
Primary Outcome ◽  
Independent Predictor ◽  
Primary Outcome Measure ◽  
High Rate ◽  
Access Site ◽  
Chronic Total Occlusions ◽  
Ultrasound Evaluation ◽  
The Mean ◽  
Severe Calcification

Purpose: To evaluate the use of the TruePath crossing device as the primary recanalization tool for infrainguinal chronic total occlusions (CTO). Methods: A retrospective analysis was conducted of 50 patients (mean age 75 years; 26 men) with 55 infrainguinal CTOs treated with the TruePath between March 2017 and September 2017 at a single center. The mean occlusion length was 138±55 mm, and femoropopliteal lesions accounted for 65% of the 55 lesions. The primary outcome measure was CTO crossing using the TruePath alone; secondary outcomes were assisted success (>50% lumen gain using the TruePath), device-related complications, and intraluminal crossing evaluated by intravascular ultrasound (IVUS). Results: Complete success was achieved in 33 (60%) of 55 lesions having a mean occlusion length of 145±72 mm. Among these, the true lumen crossing rate was 97% according to IVUS evaluation. Assisted success was achieved in 15 (68%) of the 22 failures. Complete/assisted success, in which the TruePath was thought to have contributed to CTO crossing, was attained in 48 (87%) of the 55 lesions. Three (5.5%) complications were observed: a perforation, an access-site hematoma, and acute occlusion; only the perforation was device related (1.8%). Multivariate analysis showed PACCS grade 4 (odds ratio 4.5, 95% confidence interval 1.33 to 15.5, p=0.02) was an independent predictor of TruePath failure. Conclusion: Primary use of the TruePath crossing device for infrainguinal CTOs demonstrated a satisfactory complete success rate and a high rate of IVUS-documented intraluminal crossing with few device-related complications. Severe calcification is an independent predictor of TruePath failure.

scholarly journals Effects of L-Theanine Administration on Stress-Related Symptoms and Cognitive Functions in Healthy Adults: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 2362 ◽  
Author(s):  
Hidese ◽  
Ogawa ◽  
Ota ◽  
Ishida ◽  
Yasukawa ◽  
...  
Keyword(s):  
Cognitive Functions ◽  
Verbal Fluency ◽  
Controlled Trial ◽  
Depression Scale ◽  
Healthy Adults ◽  
Placebo Administration ◽  
Double Blind ◽  
Randomized Controlled ◽  
Median Split ◽  
The Mean

This randomized, placebo-controlled, crossover, and double-blind trial aimed to examine the possible effects of four weeks L-theanine administration on stress-related symptoms and cognitive functions in healthy adults. Participants were 30 individuals (nine men and 21 women; age: 48.3 ± 11.9 years) who had no major psychiatric illness. L-theanine (200 mg/day) or placebo tablets were randomly and blindly assigned for four-week administration. For stress-related symptoms, Self-rating Depression Scale, State-Trait Anxiety Inventory-trait, and Pittsburgh Sleep Quality Index (PSQI) scores decreased after L-theanine administration (p = 0.019, 0.006, and 0.013, respectively). The PSQI subscale scores for sleep latency, sleep disturbance, and use of sleep medication reduced after L-theanine administration, compared to the placebo administration (all p < 0.05). For cognitive functions, verbal fluency and executive function scores improved after L-theanine administration (p = 0.001 and 0.031, respectively). Stratified analyses revealed that scores for verbal fluency (p = 0.002), especially letter fluency (p = 0.002), increased after L-theanine administration, compared to the placebo administration, in individuals who were sub-grouped into the lower half by the median split based on the mean pretreatment scores. Our findings suggest that L-theanine has the potential to promote mental health in the general population with stress-related ailments and cognitive impairments.

Influence of Depressive Disorder on Epilepsy Patients Life Quality

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
E. Suljic ◽  
A. Kucukalic ◽  
N. Loncarevic ◽  
A. Bravo-Mehmedbasic
Keyword(s):  
Depressive Disorder ◽  
Depressive Disorders ◽  
Life Quality ◽  
Depression Scale ◽  
Hamilton Depression Scale ◽  
Female Patients ◽  
Duration Of Illness ◽  
Clinical Center ◽  
Male Patients ◽  
Patients With Epilepsy

Introduction:Interictal depression as a co-morbid disorder can be seen among more than 40% of patients with epilepsy. Sex, epilepsy duration, type of seizures as well as applied antiepileptic drugs can cause development of depression which influence patient's life quality.Goal:To test relation between depressive disorders and patients sex, duration of illness, type of epileptic fits, antiepileptic therapy and life quality.Material and methods:Prospectively, randomly selected, we tested 300 patients with epilepsy, with or without depressive affective disorder at the Outpatient Department for Epilepsies at the Clinical Center Sarajevo. All patients answered Beck and Hamilton depression scale.Results:Baseline is consisded of male patients which made 54 % with the average age of 37.7 years, as well as female patients at average age 32.83 years. Depressive disorder according to the results at the Beck scale was present in 34%, and according to the Hamilton scale in 38.9%. Duration of illnesses longer than 20 years had 56% women with the expressed depressive disorder, compared to the 42% men's with depression (p< 0.01). Partial complex seizures were more often among women (p< 0.05). Carbamazepin as monotherapy was applied for more than a half of the baseline, and combined with carbamazepin significantly more frequently among men's (p< 0.0001), while female patients had significantly more often Lamotrigil.Conclusion:Depressive disorder is significantly more frequent among women with partial complex seizures, earlier epilepsy onset, and significantly more often on Phenobarbital therapy. Presence of depression with epilepsy significantly reduced patient's life quality.

scholarly journals Dignity Impact as a Primary Outcome Measure for Dignity Therapy

2018 ◽  
Vol 35 (11) ◽  
pp. 1417-1420 ◽  
Author(s):  
Lisa Scarton ◽  
Sungho Oh ◽  
Ashley Sylvera ◽  
Ralph Lamonge ◽  
Yingwei Yao ◽  
...  
Keyword(s):  
Palliative Care ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Meaning Making ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Care Group ◽  
Dignity Therapy ◽  
Feedback Questionnaire

Background: Feasibility of dignity therapy (DT) is well established in palliative care. Evidence of its efficacy, however, has been inconsistent and may stem from DT’s primary effects differing from the outcomes measured in previous studies. We proposed that DT effects were in the spiritual domain and created a new outcome measure, Dignity Impact Scale (DIS), from items previously used in a large randomized controlled trial (RCT). Objective: The purpose of this secondary analysis study was to examine properties of a new measure of dignity impact. Design: Using the DIS, we conducted reanalysis of posttest data from a large 3-arm, multi-site RCT study. Setting/Participants: Participants were receiving hospice/palliative care (n = 326, 50.6% female, mean age = 65.1 years, 89.3% white, all with a terminal illness with 6 months or less life expectancy). They had been randomized to standard palliative care (n = 111), client-centered care (n = 107), or DT (n = 108). Measurement: The 7-item DIS was derived from selected items in a posttest DT Patient Feedback Questionnaire. The DIS had strong internal consistency (α = 0.85). Results: The DT group mean DIS score (21.4 ± 5.0) was significantly higher than the usual care group mean score (17.7 ± 5.5; t = 5.2, df = 216, P < .001) and a client-centered intervention group mean score (17.9 ± 4.9; t = 5.2, df = 213, P < .001). Conclusion: We found that, compared to both other groups, patients who received DT reported significantly higher DIS ratings, which is consistent with the DT focus on meaning-making, preparation for death, and life completion tasks. We propose that the DIS be used as the primary outcome measure in evaluating the effects of DT.

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