scholarly journals The safety and efficacy of transcranial direct current stimulation as add-on therapy to fluoxetine in obsessive-compulsive disorder: a randomized, double-blind, sham-controlled, clinical trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Sadegh Yoosefee ◽  
Man Amanat ◽  
Mona Salehi ◽  
Seyed Vahid Mousavi ◽  
Jamshid Behzadmanesh ◽  
...  
Keyword(s):  
Adverse Events ◽  
Direct Current ◽  
Adjunctive Therapy ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Compulsive Disorder ◽  
The Mean ◽  
Experimental Group

Abstract Background Obsessive-compulsive disorder (OCD) is an anxiety disorder that causes impairment in daily activities. This study aimed to assess the safety and efficacy of transcranial direct current stimulation (tDCS) as adjunctive therapy with fluoxetine in individuals diagnosed with moderate to severe OCD. Methods This is a randomized, double-blind sham-controlled trial. Individuals with OCD who had baseline Yale-Brown obsessive-compulsive scale (Y-BOCS) of > 15 were enrolled. Eligible cases were randomly assigned in 1:1 ratio to receive either 20-min-period of stimulation with tDCS and fluoxetine (experimental arm) or fluoxetine only (sham control arm). The anodal electrode of tDCS was placed over the left dorsolateral prefrontal cortex (Fp3) and the cathodal electrode was placed over the right orbitofrontal cortex (F8). Two mA electrical stimulation with the tDCS was used for 20 min in individuals of experimental group. In the control group, electrodes were placed and stimulation was administered for 30 s to induce the same skin sensation as in experimental group. This procedure was performed three times per week for 8 weeks. Y-BOCS test was assessed at baseline, week 4 (after 12th stimulation), week 8 (after 24th stimulation), and 1 month after the last stimulation. The primary endpoints were the mean changes in Y-BOCS total score from baseline to the last visit. The secondary endpoints were the mean changes in obsession and compulsion sub-scores from baseline to the last visit. Adverse events were also assessed. Mixed design repeated measures analysis of variance assessed the endpoints. Results Sixty individuals (30 in each group) were participated. All individuals in control group and 28 cases in experimental arm completed the trial. The mean Y-BOCS (F(1.85) = 30.83; P < 0.001), OCD obsession (F(2.23) = 25.01; P < 0.001), and compulsion (F(2.06) = 10.81; P < 0.001) scores decreased significantly during the study. No statistical differences were, however, detected between experimental and control groups (P > 0.05). The tDCS was well tolerated and no major adverse events were reported. Conclusion This study showed that among individuals with moderate to severe OCD, there was no significant difference regarding OC symptoms between cases used tDCS as adjunctive therapy with fluoxetine and individuals used fluoxetine only. Trial registration IRCT2017030632904N1. Registered 14 July 2017, http://irct.ir/user/trial/44193/view

scholarly journals A randomised, double-blind, sham-controlled trial of deep brain stimulation of the bed nucleus of the stria terminalis for treatment-resistant obsessive-compulsive disorder

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Philip E. Mosley ◽  
François Windels ◽  
John Morris ◽  
Terry Coyne ◽  
Rodney Marsh ◽  
...  
Keyword(s):  
Deep Brain Stimulation ◽  
Adverse Events ◽  
Brain Stimulation ◽  
Stria Terminalis ◽  
Treatment Resistant ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Bed Nucleus ◽  
Compulsive Disorder ◽  
Deep Brain

AbstractDeep brain stimulation (DBS) is a promising treatment for severe, treatment-resistant obsessive-compulsive disorder (OCD). Here, nine participants (four females, mean age 47.9 ± 10.7 years) were implanted with DBS electrodes bilaterally in the bed nucleus of the stria terminalis (BNST). Following a one-month postoperative recovery phase, participants entered a three-month randomised, double-blind, sham-controlled phase before a twelve-month period of open-label stimulation incorporating a course of cognitive behavioural therapy (CBT). The primary outcome measure was OCD symptoms as rated with the Yale-Brown Obsessive-Compulsive Scale (YBOCS). In the blinded phase, there was a significant benefit of active stimulation over sham (p = 0.025, mean difference 4.9 points). After the open phase, the mean reduction in YBOCS was 16.6 ± 1.9 points (χ2 (11) = 39.8, p = 3.8 × 10−5), with seven participants classified as responders. CBT resulted in an additive YBOCS reduction of 4.8 ± 3.9 points (p = 0.011). There were two serious adverse events related to the DBS device, the most severe of which was an infection during the open phase necessitating device explantation. There were no serious psychiatric adverse events related to stimulation. An analysis of the structural connectivity of each participant’s individualised stimulation field isolated right-hemispheric fibres associated with YBOCS reduction. These included subcortical tracts incorporating the amygdala, hippocampus and stria terminalis, in addition to cortical regions in the ventrolateral and ventromedial prefrontal cortex, parahippocampal, parietal and extrastriate visual cortex. In conclusion, this study provides further evidence supporting the efficacy and tolerability of DBS in the region of the BNST for individuals with otherwise treatment-refractory OCD and identifies a connectivity fingerprint associated with clinical benefit.

THE CUT-OFF POINT IN SUB-CLINICAL OBSESSIVE-COMPULSIVE RESEARCH

2000 ◽  
Vol 28 (3) ◽  
pp. 225-233 ◽  
Author(s):  
David Mataix-Cols ◽  
Julio Vallejo ◽  
Miquel Sànchez-Turet
Keyword(s):  
Selection Criteria ◽  
Methodological Issue ◽  
Theoretical Models ◽  
Control Group ◽  
Personality Measures ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Wide Range ◽  
The Mean ◽  
Selection Of

The question of which cut-off point would be more appropriate in the selection of sub-clinical obsessive-compulsive (OC) samples is an important methodological issue that has not been formally addressed, hence prompting the current study. Three groups of sub-clinical OC subjects, scoring 1, 1.5, and 2 standard deviations (SD) above the mean on the Padua Inventory, and a matched non-OC control group, were compared on various clinical and personality measures. As expected, the three sub-clinical groups had higher scores than the non-OC group on measures of OC symptoms (including obsessional slowness), depression, anxiety, and on personality measures of neuroticism, psychoticism, and obsessional traits. However, no significant differences were observed between the three sub-clinical groups on most measures, although the 2 SD group had higher scores on neuroticism and obsessional personality traits. It is concluded that a wide range of selection criteria can yield similar results that are interpretable within the current theoretical models of Obsessive-Compulsive Disorder (OCD). It is suggested that subjects with a diagnosis of OCD should be carefully excluded from sub-clinical studies. [A Spanish abstract follows the references.]

scholarly journals Efficacy of the Cognitive and Exposure Therapy in the Treatment of Obsessive-Compulsive Disorder

2013 ◽  
Vol 11 ◽  
pp. 1-9
Author(s):  
Hiva Mahmoodi ◽  
Hasan Gharibi ◽  
Mohamad Khaledian
Keyword(s):  
Cognitive Therapy ◽  
Obsessive Compulsive Disorder ◽  
Exposure Therapy ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Statistical Population ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
Experimental Group

The aim of this study was the investigation of the efficacy of the Cognitive and Exposure therapy on the treatment of obsessive- compulsive disorder. This study is experimental expanded with multiple group pre-test, post-test. The statistical population of this study are included all patients with OCD, referred to clinical centers, hospitals and private clinics and counseling centers in Saghez and Boukan citiesat the age of 40-20 years. The statistical sample of this study is included 45 patientswith Obsessive Compulsive Disorder, Who were selected randomly. Cognitive therapy was administered for the first experimental group and the second experimental group receives exposure therapy while the control group received no treatment. Subscales Madsly questionnaire was usedfor data gathering for OCD. For data analysis, multivariate analysis of covariance (MANCOVA) and least significant difference test to compare scores differences between pretest - posttest variables in the experimental and control groups was used. Findings showed that Cognitive and Aversion Therapy on the control group has a significant impact on the improvement of obsession, check out, washing, slowness and obsessive doubts. The results showed that Whittal Cognitive Therapy more impact on the reduction of obsessions in comparsion with Exposure therapy.

scholarly journals Anerning Granule for Community Acquired Pneumonia: Protocol for Randomized, Double-Blind, Single-Dummy, Parallel Control of Placebo, Multicenter Clinical Trial

2021 ◽  
Author(s):  
Menghua Sun ◽  
Jian Lyu ◽  
Yi-li Zhang ◽  
Xu Wei ◽  
Li-dan Zhang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Community Acquired Pneumonia ◽  
Clinical Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Ceftriaxone Sodium ◽  
Parallel Control ◽  
Experimental Group

Abstract Background: Community acquired pneumonia (CAP) in children is one of the common clinical diseases and infectious diseases threatening the health of the population. CAP has complicated causes, closely related to region, season, age, and primary disease. It is the most common cause of children being hospitalized and the first cause of death for children under 5 years old. At present, the clinical treatment is mainly antibiotics, but abuse and non-standard combination of antibiotics have led to increasing antibiotic resistance. Anerning Granules have the functions of clearing away heat and removing wind, reducing phlegm and relieving cough, and improving cough symptoms and lung signs. Thus, this study aims to evaluate the efficacy and safety of Anerning Granules (AEN) in the treatment of community-acquired pneumonia in children, and to explore whether AEN can reduce the use of antibiotics and have a good effect on the clinical treatment of CAP.Methods and analysis: this study, a randomized, double-blind, single-dummy, parallel control of placebo, multicenter clinical study will be established in 7 hospitals in the same period. A total of 216 patients with community-acquired pneumonia will be randomly allocated at a ratio of 2:1 to two groups: experimental group, control group. The experimental group receives Anerning Granules plus ceftriaxone sodium; the control group receives AEN placebo plus ceftriaxone sodium. Each group will be treated for ten days, and a stage effect evaluation will be conducted on the sixth day. The primary outcome is the end of antibiotics in frequency (DDDs) and effective rate. Secondary outcome measures of effectiveness are the full fever time, sore throat onset time, and safety assessment. Outcomes will be assessed at baseline and after treatment. In addition, adverse events will be monitored throughout the trial process and must be traced to be resolved.Discussion: This study protocol will provide the research data regarding the efficacy and safety of AEN for the treatment of community-acquired pneumonia in children. The first aim is to determine whether Anerning Granules can reduce the use of antibiotics; the second aim is to evaluate the effectiveness of Anerning Granules combined with ceftriaxone sodium in the treatment of children with community-acquired pneumonia. The third aim is to observe the safety of clinical application of Anerning Granules. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices of adverse events, which will provide reliable evidence for clinical treatment.Trial registration: Clinicaltrials.gov identifier: NCT03675178, registered on 16 September 2018.

A double-blind comparison of sertraline and clomipramine in outpatients with obsessive-compulsive disorder

1997 ◽  
Vol 12 (2) ◽  
pp. 82-93 ◽  
Author(s):  
JC Bisserbe ◽  
RM Lane ◽  
MF Flament ◽  
Keyword(s):  
Adverse Events ◽  
Obsessive Compulsive Disorder ◽  
Depression Scale ◽  
Final Visit ◽  
Hamilton Depression Scale ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Number Of Patients ◽  
Intent To Treat

SummaryThe aim of this study was to compare the efficacy, safety, and tolerability of sertraline and clomipramine in the treatment of obsessive-compulsive disorder (OCD). Outpatients with DSM-III-R defined OCD for 1 year or longer and scores of ≥ 20 on the YaleBrown Obsessive Compulsive Scale (Y-BOCS), ≥ 7 on the National Institute of Mental Health Global Obsessive-Compulsive Scale (NIMH-OC), ≥ 4 on the Clinical Global Impression Severity of Illness Scale (CGI-S) and ≤17 on the Hamilton Depression Scale (17 item HAMD) were randomized to sertraline (n = 86) or clomipramine (n = 82) once daily for 16 weeks. Initial daily doses of sertraline and clomipramine were 50 mg. After a minimum of 4 weeks, these doses could be increased by 50 mg increments every 2 weeks to a maximum of 200 mg daily if the response was thought inadequate. Efficacy was assessed at the end of 1, 2, 4, 6, 8, 12 and 16 weeks of therapy using the Y-BOCS, NIMH-OC, CGI-S, CGI Improvement Scale (CGI-I) and Clinical Anxiety Scale (CAS). One hundred sixty-eight patients were randomized and received at least one dose of double-blind medication; 86 received sertraline and 82 clomipramine. Mean final daily doses at final visit were clomipramine 90 mg (efficacy evaluable patients 101 mg, completers 110 mg), and sertraline 129 mg (efficacy evaluable patients 132 mg, completers 136 mg). Mean baseline Y-BOCS, NIMH-OC and CGI-S totals were 27.7, 10.1 and 5.5, respectively, for sertraline and 27.4, 9.9 and 5.5, respectively, for clomipramine. Sertraline demonstrated greater efficacy than clomipramine in the intent-to-treat patient group: mean baseline to final visit changes were 50.8% (Y-BOCS), 41.9% (NIMH-OC) and 37.7% (CGI-S) for sertraline and 42.9% (Y-BOCS), 33.8% (NIMH-OC) and 30.0% (CGI-S) for clomipramine (P < 0.05). The number of patients withdrawing because of adverse events was substantially greater for clomipramine (26%) than sertraline (11%) (P < 0.05). The most frequent adverse events for clomipramine were dry mouth (20%), anxiety (17%), constipation (16%), nausea (15%) and somnolence (11%), and for sertraline, diarrhea (12%) and nausea (12%). In this study, sertraline was more effective than clomipramine in the intent-to-treat analysis. The difference in efficacy between the treatments is almost wholly accounted for by a greater number of clomipramine withdrawals due to the poor patient acceptance of clomipramine. The superior tolerability of sertraline and the lower rate of premature treatment withdrawal relative to clomipramine may offer considerable quality of life and compliance benefits in the long-term management of a chronic disorder such as OCD.

scholarly journals Memantine Augmentation Improves Symptoms in Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder: A Randomized Controlled Trial

2017 ◽  
Vol 51 (06) ◽  
pp. 263-269 ◽  
Author(s):  
Atieh Modarresi ◽  
Mehdi Sayyah ◽  
Setareh Razooghi ◽  
Kaveh Eslami ◽  
Mohammadreza Javadi ◽  
...  
Keyword(s):  
Treatment Response ◽  
Controlled Trial ◽  
Large Body ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Randomized Controlled ◽  
Clinical Benefits ◽  
The Mean ◽  
To Receive

Abstract Introduction There is a large body of evidence on the clinical benefits of augmentation therapy with glutamate-modulating agents, such as memantine in reducing OCD symptoms. Methods A double-blind, placebo-controlled trial was conducted on SRIrefractory OCD patients. Thirty-two patients were randomized to receive either 20 mg/day memantine or placebo augmentation and were visited at baseline and every 4 weeks for 12 weeks. Results were measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Results The Y-BOCS total score was significantly reduced in the memantine group at the end of weeks 8 and 12, while no improvement was observed in the placebo group throughout the trial. A reduction of 40.9% in the mean Y-BOCS total score by week 12 in the memantine group resulted in 73.3% of patients achieving treatment response. The findings showed that a time to effect of 8 weeks was necessary to observe significant improvement in OCD symptoms, while treatment response was only seen after 12 weeks of memantine augmentation. Discussion Memantine is an effective and well-tolerated augmentation in severe OCD patients refractory to SRI monotherapy.

scholarly journals Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

2015 ◽  
Vol 95 (3) ◽  
pp. 337-349 ◽  
Author(s):  
Bernadette T. Gillick ◽  
Tim Feyma ◽  
Jeremiah Menk ◽  
Michelle Usset ◽  
Amy Vaith ◽  
...  
Keyword(s):  
Adverse Events ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Hand Function ◽  
Behavioral Data ◽  
Control Group ◽  
Double Blind ◽  
Direct Current Stimulation ◽  
Preliminary Study

Background Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. Objective The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. Design A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. Setting The study was conducted in a university pediatric research laboratory. Participants Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Measurements Adverse events/safety assessment and hand function were measured. Intervention Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. Results No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. Limitations A limitation of the study was the small sample size, with data available for 11 participants. Conclusions Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function.

scholarly journals A Randomised, Double-Blind, Sham-Controlled Trial of Deep Brain Stimulation of the Bed Nucleus of the Stria Terminalis for Treatment-Resistant Obsessive-Compulsive Disorder

2020 ◽  
Author(s):  
Philip E. Mosley ◽  
François Windels ◽  
John Morris ◽  
Terry Coyne ◽  
Rodney Marsh ◽  
...  
Keyword(s):  
Deep Brain Stimulation ◽  
Adverse Events ◽  
Brain Stimulation ◽  
Stria Terminalis ◽  
Treatment Resistant ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Bed Nucleus ◽  
Compulsive Disorder ◽  
Deep Brain

1ABSTRACTDeep brain stimulation (DBS) is a promising treatment for severe, treatment-resistant obsessive-compulsive disorder (OCD). Here, nine participants (four females, mean age 47.9 ±10.7 years) were implanted with DBS electrodes bilaterally in the bed nucleus of the stria terminalis (BNST). Following a one-month postoperative recovery phase, participants entered a three-month randomised, double-blind, sham-controlled phase before a twelve-month period of open-label stimulation incorporating a course of cognitive behavioural therapy (CBT). The primary outcome measure was OCD symptoms as rated with the Yale-Brown Obsessive-Compulsive Scale (YBOCS). In the blinded phase, there was a significant benefit of active stimulation over sham (p = 0.025, mean difference 4.9 points). After the open phase, the mean reduction in YBOCS was 16.6 ±1.9 points (Χ2 (11) = 39.8, p = 3.8 × 10−5), with seven participants classified as responders. CBT resulted in an additive YBOCS reduction of 4.8 ±3.9 points (p = 0.011). There were two serious adverse events related to the DBS device, the most severe of which was an infection during the open phase necessitating device explantation. There were no psychiatric adverse events related to stimulation. An analysis of the structural connectivity of each participant’s individualised stimulation field isolated right-hemispheric fibres associated with YBOCS reduction. These included subcortical tracts incorporating the amygdala, hippocampus and stria terminalis, in addition to cortical regions in the ventrolateral and ventromedial prefrontal cortex, parahippocampal, parietal and extrastriate visual cortex. In conclusion, this study provides further evidence supporting the efficacy and tolerability of DBS for individuals with otherwise treatment-refractory OCD and identifies a connectivity fingerprint associated with clinical benefit.

Paroxetine concentrations in obsessive-compulsive disorder: Support for a therapeutic interval

2017 ◽  
Vol 41 (S1) ◽  
pp. S322-S322
Author(s):  
M.B. Humble ◽  
M. Reis
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Clinical Symptoms ◽  
Global Evaluation ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Number Of Patients ◽  
The Mean ◽  
Competing Interest ◽  
L 13

IntroductionPrevious studies of concentrations of serotonin reuptake inhibitors (SRIs) versus therapeutic efficacy have yielded inconsistent results. Even if the relationships between the individual's serotonergic system and the clinical symptoms of obsessive-compulsive disorder (OCD) are poorly understood, the SRIs are consistently effective in OCD. However, studies on SRI concentrations in OCD treatment are rare.Objectives/aimsTo identify possible links between paroxetine concentrations and anti-obsessive response.MethodsIn a randomised, double-blind trial, comparing clomipramine, paroxetine and placebo in OCD treatment, serum paroxetine levels were measured after 1 week and after 4 weeks of treatment in 18 patients. Anti-obsessive response was assessed with Yale-Brown obsessive compulsive scale (Y-BOCS) and patients’ global evaluation (PGE), after 12 weeks of treatment.ResultsSerum paroxetine concentrations after 4 weeks suggested a therapeutic interval between 50 and 240 nmol/L (13–63 ng/mL). The mean Y-BOCS decrease was 54% inside versus 7% outside this interval (t = 3.96; P = 0.0011).ConclusionsParoxetine levels seemingly predicted clinical outcome. Studies with a greater number of patients are necessary in order to confirm this finding and to discern whether it is useful in clinical practice.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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