Abstract 52: Efficacy and Safety of Mipomersen in Patients with Familial Hypercholesterolemia and Inadequately Controlled LDL-C Levels

2016 ◽  
Vol 36 (suppl_1) ◽  
Author(s):  
Christie Ballantyne ◽  
Alberico L Catapano ◽  
Michael Davidson ◽  
Robert Mittleman ◽  
Patrick M Moriarty ◽  
...  
Keyword(s):  
Adverse Events ◽  
Familial Hypercholesterolemia ◽  
Repeated Measures ◽  
Mixed Model ◽  
Primary Objective ◽  
Tolerability Profile ◽  
Primary Analysis ◽  
Double Blind ◽  
Absolute Reduction ◽  
Over Time

Aim: Mipomersen is an antisense oligonucleotide inhibitor of apolipoprotein B-100 synthesis, FDA-approved to treat homozygous familial hypercholesterolemia. The primary objective of this study was to determine whether mipomersen significantly reduced atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (HeFH). Methods: This was a randomized, double-blind, placebo-controlled, parallel-group study comprised of two cohorts (NCT01475825). Cohort 1 had severe HeFH (LDL-C ≥200 mg/dL + coronary heart disease, or LDL-C ≥300 mg/dL) and Cohort 2 had milder HeFH (LDL-C ≥160 and <200 mg/dL). For each cohort, patients were randomized 1:1 to 200 mg SC once weekly or 70 mg SC thrice weekly, then 2:1 to receive mipomersen or placebo for 60 weeks. The primary outcome was percent change from baseline in LDL-C in Cohort 1. The % change from baseline in LDL-C at Week 61 for mipomersen treated patients was compared to placebo using a mixed model for repeated measures (MMRM), as well as by ANCOVA on the value closest to 7 days post last treatment (LOCF). Results: Mean baseline LDL-C levels were 265 mg/dL in Cohort 1 (N=200) and 176 mg/dL in Cohort 2 (N=109). In Cohort 1, mipomersen 200 mg weekly reduced LDL-C levels by -29.7% (vs -7.9% placebo, P <.001) in the mixed model, and by -36.3% (vs -7.6% placebo, P <.001) using the LOCF. Analysis of LDL-C over time (Figure) showed a mean absolute reduction of 138 mg/dL in mipomersen patients who completed the blinded treatment period (n=32), achieving a mean level of 147 mg/dL from a mean 285 mg/dL baseline level. Tolerability to treatment and adverse events were similar between dose regimens. Adverse events were consistent with the drug’s known safety and tolerability profile. Conclusions: The primary analysis showed a significant reduction in LDL-C levels in patients with severe HeFH who received mipomersen 200 mg once weekly versus placebo. A highly relevant absolute reduction in LDL-C was achieved over time.

scholarly journals Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dulanji K. Kuruppu ◽  
Joshua Tobin ◽  
Yan Dong ◽  
Sheena K. Aurora ◽  
Laura Yunes-Medina ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Migraine Headache ◽  
Mixed Model ◽  
Preventive Treatment ◽  
Response Rates ◽  
Toxin A ◽  
Double Blind ◽  
Preventive Medication ◽  
Onabotulinum Toxin A ◽  
Post Hoc

Abstract Background Galcanezumab is a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) indicated for the preventive treatment of migraine. While galcanezumab has demonstrated efficacy in patients who did not respond to prior preventive medications in general, its efficacy in patients who did not benefit from individual, commonly prescribed preventive treatments due to inadequate efficacy or safety/tolerability remains unknown. Methods CONQUER was a 3-month, randomized, double-blind, placebo-controlled, phase 3b study that enrolled patients with episodic or chronic migraine who had 2 to 4 migraine preventive medication category failures in the past 10 years. Patients were randomly assigned 1:1 to receive placebo (N = 230) or galcanezumab 120 mg/month (240 mg loading dose; N = 232). Post hoc analyses were conducted to determine the efficacy of galcanezumab in patients who had not benefited from six of the most commonly prescribed migraine preventive medications. The mean change from baseline in monthly migraine headache days and ≥ 50 % response rates were assessed over months 1–3. Improvement in Migraine-Specific Questionnaire Role Function-Restrictive (MSQ-RFR) scores were assessed at month 3. The endpoints were estimated via mixed model with repeated measures. Results The most common treatment failures due to inadequate efficacy or safety/tolerability, which at least 20 % of patients reported trying without benefit, included topiramate, amitriptyline, propranolol, valproate or divalproex, onabotulinum toxin A, and metoprolol. Patients who had not previously benefited from these treatments had a greater mean reduction in monthly migraine headache days across months 1–3 in the galcanezumab group compared to placebo (all p < 0.01). More patients treated with galcanezumab experienced a ≥ 50 % reduction from baseline in monthly migraine headache days across months 1–3 compared to placebo (all p < 0.05). Galcanezumab-treated patients had a greater improvement in mean MSQ-RFR scores at month 3 compared to placebo (all p < 0.01). Conclusions In this population, galcanezumab was effective in reducing monthly migraine headache days, improving response rates, and enhancing quality of life in patients who had not previously benefited from topiramate, amitriptyline, propranolol, valproate or divalproex, onabotulinum toxin A, and/or metoprolol due to inadequate efficacy or safety/tolerability. Trial registration ClinicalTrials.gov NCT03559257 (CONQUER).

The Efficacy of Lurasidone on PANSS Subscales in Adolescent Patients with Schizophrenia: Results from a 6-week, Double-blind, Placebo-controlled, Multicenter Study

2017 ◽  
Vol 41 (S1) ◽  
pp. S90-S91 ◽  
Author(s):  
C. Correll ◽  
R. Goldman ◽  
J. Cucchiaro ◽  
L. Deng ◽  
A. Loebel
Keyword(s):  
Repeated Measures ◽  
Mixed Model ◽  
Wide Spectrum ◽  
Dose Range ◽  
Data Safety Monitoring Board ◽  
Double Blind ◽  
Meaningful Improvement ◽  
General Psychopathology ◽  
Adolescent Patients ◽  
Adjusted Least Squares

IntroductionLurasidone is an atypical antipsychotic that demonstrated efficacy in the treatment of adults with schizophrenia in the dose range of 37–148 mg/day.Objective/AimsThe objective of this analysis was to evaluate the efficacy of lurasidone in adolescent patients with schizophrenia.MethodsAdolescents (13–17 years old) diagnosed with schizophrenia were randomly assigned to six weeks of double-blind treatment with lurasidone 37 mg/day, 74 mg/day or placebo. Changes from baseline to week 6 in PANSS total and subscale (positive, negative, general psychopathology, excitability) scores were evaluated using mixed-model repeated-measures analysis.ResultsA total of 326 patients (mean age, 15.4 years) were randomized and received lurasidone 37 mg/day (n = 108), 74 mg/day (n = 106), or placebo (n = 112). The PANSS total score at week 6 demonstrated a placebo-adjusted, least-squares (LS) mean improvement of –8.0 (P < 0.001; effect size [ES], 0.51) for the 37 mg/day group and –7.7 (P < 0.001; ES = 0.48) for the 74 mg/day group. Placebo-adjusted LS mean change for lurasidone 37 mg/day and 74 mg/day, respectively, was –3.2 (P < 0.001; ES = 0.62) and –3.2 (P < 0.001; ES = 0.60) on the PANSS positive subscale, –1.7 (P = 0.011; ES = 0.41) and –1.6 (P = 0.022; ES = 0.35) on the PANSS negative subscale, –2.8 (P = 0.012; ES = 0.38) and –2.8 (P = 0.011; ES = 0.37) on the PANSS general psychopathology subscale, and –1.1 (P = 0.016; ES = 0.36) and –1.8 (P < 0.001; ES = 0.53) on the PANSS excitability subscale.ConclusionsIn adolescent patients with schizophrenia, lurasidone (37 mg/day and 74 mg/day) demonstrated statistically significant efficacy and clinically meaningful improvement across a wide spectrum of symptoms associated with schizophrenia. Sponsored by Sunovion Pharmaceuticals Inc. ClinicalTrials.gov identifier: NCT01911429.Disclosure of interestDr Correll reports being a consultant and/or advisor for Alkermes, Forum Pharmaceuticals Inc., Gerson Lehrman Group, IntraCellular Therapies, Janssen/J&J, Lundbeck, Medavante, Medscape, Otsuka, Pfizer Inc, ProPhase, Sunovion Pharmaceuticals Inc., Supernus, Takeda, and Teva providing expert testimony for Bristol-Myers Squibb Company, Janssen, and Otsuka serving on a Data Safety Monitoring Board for Lundbeck and Pfizer Inc and receiving grant support from Takeda. Drs Goldman, Cucchiaro, Deng and Loebel are employees of Sunovion Pharmaceuticals Inc.

scholarly journals Mood and Global Symptom Changes among Psychotherapy Clients with Depressive Personality

2012 ◽  
Vol 2012 ◽  
pp. 1-12
Author(s):  
Rachel E. Maddux ◽  
Lars-Gunnar Lundh
Keyword(s):  
Repeated Measures ◽  
Mixed Model ◽  
Psychological Symptoms ◽  
Self Report ◽  
Treatment Results ◽  
Repeated Measures Analysis ◽  
Depressive Personality ◽  
Symptom Changes ◽  
Psychotherapy Clients ◽  
Over Time

The present study assessed the rate of depressive personality (DP), as measured by the self-report instrument depressive personality disorder inventory (DPDI), among 159 clients entering psychotherapy at an outpatient university clinic. The presenting clinical profile was evaluated for those with and without DP, including levels of depressed mood, other psychological symptoms, and global severity of psychopathology. Clients were followed naturalistically over the course of therapy, up to 40 weeks, and reassessed on these variables again after treatment. Results indicated that 44 percent of the sample qualified for DP prior to treatment, and these individuals had a comparatively more severe and complex presenting disposition than those without DP. Mixed-model repeated-measures analysis of variance was used to examine between-groups changes on mood and global severity over time, with those with DP demonstrating larger reductions on both outcome variables, although still showing more symptoms after treatment, than those without DP. Only eleven percent of the sample continued to endorse DP following treatment. These findings suggest that in routine clinical situations, psychotherapy may benefit individuals with DP.

TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽  
2021 ◽  
pp. 033310242110474
Author(s):  
Debashish Chowdhury ◽  
Luv Bansal ◽  
Ashish Duggal ◽  
Debabrata Datta ◽  
Ankit Mundra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Virus Disease ◽  
Controlled Trial ◽  
Preventive Treatment ◽  
Point Estimate ◽  
Tolerability Profile ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

Post hoc analysis of a randomised, placebo-controlled, active-reference 6-week study of brexpiprazole in acute schizophrenia

2020 ◽  
Vol 32 (3) ◽  
pp. 153-158 ◽  
Author(s):  
Stephen R. Marder ◽  
Hans Eriksson ◽  
Yudong Zhao ◽  
Mary Hobart
Keyword(s):  
Adverse Events ◽  
Repeated Measures ◽  
Mixed Model ◽  
Least Square ◽  
Analysis Of Covariance ◽  
Sensitivity Analyses ◽  
Symptom Improvement ◽  
Syndrome Scale ◽  
Quetiapine Xr ◽  
Post Hoc

AbstractObjective:We provide a closer look at the result of a randomised, placebo-controlled, active-reference (quetiapine XR), flexible-dose, 6-week study of brexpiprazole in schizophrenia, which did not meet its primary endpoint – change from baseline in Positive and Negative Syndrome Scale (PANSS) total score. We also investigate potential expectancy bias from the well-known side-effect profile of the active reference that could have affected the study outcome.Methods:Pre-specified sensitivity analyses of the primary end point were performed using analysis of covariance (ANCOVA) last observation carried forward (LOCF) and observed cases (OC). Post hoc analyses of change from baseline in PANSS total score were performed using the mixed model for repeated measures approach with treatment groups split by having typical adverse events with potential for functional unblinding, for example, somnolence, increase in weight, dizziness, dry mouth and sedation.Results:Pre-specified sensitivity analyses showed separation from placebo for brexpiprazole at week 6: LOCF, ANCOVA: −4.3 [95% CI (−8.0, −0.5), p = 0.0254]. OC, ANCOVA: −3.9 [95% CI (−7.3, −0.5), p = 0.0260]. Patients treated with brexpiprazole experiencing typical adverse events with potential for functional unblinding before or at Week 2 had a least square (LS) mean PANSS change of −29.5 (improvement), with a difference in change from baseline to Week 6 in PANSS total score between brexpiprazole and placebo of −13.5 [95% CI (−23.1, −4.0), p = 0.0057], and those who did not had an LS mean change of −18.9 and a difference between brexpiprazole and placebo of −2.9 [95% CI (−7.2, 1.4), p = 0.1809].Conclusion:Pre-specified sensitivity analyses showed separation from placebo for brexpiprazole at Week 6. A post hoc analysis suggested a potential confounding of efficacy rating towards symptom improvement in patients who experience known side effects of quetiapine XR.

scholarly journals A Randomized, Placebo-Controlled, Respiratory Syncytial Virus Human Challenge Study of the Antiviral Efficacy, Safety, and Pharmacokinetics of RV521, an Inhibitor of the RSV-F Protein

2019 ◽  
Vol 64 (2) ◽  
Author(s):  
John DeVincenzo ◽  
Dereck Tait ◽  
John Efthimiou ◽  
Julie Mori ◽  
Young-In Kim ◽  
...  
Keyword(s):  
Viral Load ◽  
Respiratory Syncytial Virus ◽  
Adverse Events ◽  
Disease Severity ◽  
Controlled Trial ◽  
Primary Analysis ◽  
Double Blind ◽  
Challenge Virus ◽  
F Protein ◽  
Syncytial Virus

ABSTRACT Effective treatments for respiratory syncytial virus (RSV) infection are lacking. Here, we report a human proof-of-concept study for RV521, a small-molecule antiviral inhibitor of the RSV-F protein. In this randomized, double-blind, placebo-controlled trial, healthy adults were challenged with RSV-A Memphis-37b. After infection was confirmed (or 5 days after challenge virus inoculation), subjects received RV521 (350 mg or 200 mg) or placebo orally every 12 h for 5 days. The primary endpoint was area under the curve (AUC) for viral load, as assessed by reverse transcriptase quantitative PCR (RT-qPCR) of nasal wash samples. The primary efficacy analysis set included subjects successfully infected with RSV who received ≥1 dose of study drug. A total of 66 subjects were enrolled (n = 22 per group); 53 were included in the primary analysis set (RV521 350 mg: n = 16; 200 mg: n = 18; placebo: n = 19). The mean AUC of RT-qPCR-assessed RSV viral load (log10 PFU equivalents [PFUe]/ml · h) was significantly lower with RV521 350 mg (185.26; standard error [SE], 31.17; P = 0.002) and 200 mg (224.35; SE, 37.60; P = 0.007) versus placebo (501.39; SE, 86.57). Disease severity improved with RV521 350 mg and 200 mg versus placebo (P = 0.002 and P = 0.009, respectively, for AUC total symptom score [score × hours]). Daily nasal mucus weight was significantly reduced (P = 0.010 and P = 0.038 for RV521 350 mg and 200 mg, respectively, versus placebo). All treatment-emergent adverse events were grade 1 or 2. No subjects discontinued due to adverse events. There was no evidence of clinically significant viral resistance, and only three variants were detected. RV521 effectively reduced RSV viral load and disease severity in humans and was well tolerated. (This study has been registered at ClinicalTrials.gov under registration no. NCT03258502.)

scholarly journals Two vs. three weeks of treatment with amoxicillin-clavulanate for stabilized community-acquired complicated parapneumonic effusions. A preliminary non-inferiority, double-blind, randomized, controlled trial

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
José M. Porcel ◽  
Lucia Ferreiro ◽  
Laura Rumi ◽  
Esther Espino-Paisán ◽  
Carmen Civit ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Success ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Primary Objective ◽  
Double Blind ◽  
Pleural Thickening ◽  
Small Series ◽  
Amoxicillin Clavulanate ◽  
Clinical Stability

AbstractBackgroundThe optimal duration of antibiotic treatment for complicated parapneumonic effusions (CPPEs) has not been properly defined. Our aim was to compare the efficacy of amoxicillin-clavulanate for 2 vs. 3 weeks in patients with CPPE (i.e. those which required chest tube drainage).MethodsIn this non-inferiority, randomized, double-blind, controlled trial, patients with community-acquired CPPE were recruited from two centers in Spain and, after having obtained clinical stability following 2 weeks of amoxicillin-clavulanate, they were randomly assigned to placebo or antibiotic for an additional week. The primary objective was clinical success, tested for a non-inferiority margin of<10%. Secondary outcomes were the proportion of residual pleural thickening of>10 mm at 3 months, and adverse events. The study was registered with EudraCT, number 2014-003137-25. We originally planned to randomly assign 284 patients.ResultsAfter recruiting 55 patients, the study was terminated early owing to slow enrolment. A total of 25 patients were assigned to 2 weeks and 30 patients to 3 weeks of amoxicillin-clavulanate. Clinical success occurred in the 25 (100%) patients treated for 2 weeks and 29 (97%) treated for 3 weeks (difference 3%, 95% CI −3 to 9.7%). Respective between-group differences in the rate of residual pleural thickening (−12%, 95%CI −39 to 14%) and adverse events (−7%, 95%CI −16 to 2%) did not reach statistical significance.ConclusionsIn this small series of selected adult patients with community-acquired CPPE, amoxicillin-clavulanate treatment could be safely discontinued by day 14 if clinical stability was obtained.

scholarly journals Assessing Early Behavioral Indicators of Tolerance in Infants Receiving Formula with Added Lactobacillus rhamnosus GG (LGG)

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 998-998
Author(s):  
Fabiola Gutierrez-Orozco ◽  
Cheryl Harris ◽  
Jennifer Wampler ◽  
Carol Lynn Berseth
Keyword(s):  
Infant Formula ◽  
Repeated Measures ◽  
Lactobacillus Rhamnosus ◽  
Study Groups ◽  
Parent Report ◽  
Infantile Colic ◽  
Double Blind ◽  
Behavioral Indicators ◽  
Funding Sources ◽  
Over Time

Abstract Objectives To evaluate the nutritive effects of an infant formula with added LGG on early behavioral indicators of tolerance in infants experiencing crying and fussing often associated with infantile colic. Methods In this single-center, double-blind, controlled, parallel, prospective study, infants (14 to 28 days of age) determined to cry and/or fuss ≥3 hours/day for ≥3 days/week (in a one-week period) were randomized to receive one of two formulas over a 21-day feeding period: marketed partially hydrolyzed (PH) cow's milk-based infant formula (PH: n, 35) or a similar formula with added LGG (PH-LGG: n, 36). Parents/caregivers used a validated parent-report diary to record crying/fussing and awake/content behavior at three time points: Study Days 2–4 (baseline), Days 10–12, and Days 18–20 (Study End). The primary outcome, duration (hours/day) of crying/fussing (averaged over each three-day period), was analyzed by repeated measures, mixed-effects models. Results Birth characteristics (sex, race, weight) and age (days; mean ± SE) at study entry (PH: 19.7 ± 0.8; PH-LGG: 19.3 ± 0.8) were similar for study groups. No group differences in mean study formula intake (g/day) or mean achieved weight (g) at any study time point were detected. Completion rates were similar through Day 21 (PH: n = 33, 94%; PH-LGG: n = 33, 92%). Duration of crying/fussing (mean ± SE) decreased over time with no significant differences detected in the PH vs PH-LGG group at Baseline (4.8 ± 0.3 vs 4.0 ± 0.3; P = 0.086), Days 10–12 (3.5 ± 0.3 vs 2.6 ± 0.3; P = 0.056), and Days 18–20 (2.1 ± 0.3 vs 1.5 ± 0.3; P = 0.227). Duration of awake/content behavior increased over time with no significant differences detected in PH vs PH-LGG: Baseline (1.0 ± 0.5 vs 1.2 ± 0.5; P = 0.786), Days 10–12 (1.3 ± 0.5 vs 1.6 ± 0.5; P = 0.627), and Days 18–20 (2.1 ± 0.5 vs 2.2 ± 0.5; P = 0.884). By Study End, only 8 (24%) in the PH and 9 (27%) in the PH-LGG group continued to cry and/or fuss ≥3 hours/day for ≥3 days/week. Conclusions In the present pilot study, we identified a study population of infants early in life experiencing crying and fussing often associated with infantile colic. Both study formulas were well tolerated. Crying/fussiness decreased and awake/content behavior increased in both study groups over the course of the study. Funding Sources Mead Johnson Nutrition.

scholarly journals Sexual Function during Bupropion or Paroxetine Treatment of Major Depressive Disorder

2006 ◽  
Vol 51 (4) ◽  
pp. 234-242 ◽  
Author(s):  
Sidney H Kennedy ◽  
Kari A Fulton ◽  
R Michael Bagby ◽  
Andrea L Greene ◽  
Nicole L Cohen ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Sexual Function ◽  
Rating Scale ◽  
Primary Objective ◽  
Major Depressive ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive ◽  
Over Time

Objective: The primary objective was to evaluate sexual function (SF) separately in men and women with major depressive disorder (MDD) before and during treatment with bupropion sustained release (SR) or paroxetine. The secondary objectives involved a comparative evaluation of the Sex Effects Scale (Sex FX) and the Investigator-Rated Sexual Desire and Functioning Scale (IRSD-F), as well as a comparison of antidepressant outcomes and an examination of the relation between level of depression and SF over time. Method: There were 141 patients (68 women and 73 men) who met DSM-IV criteria for a current major depressive episode. They were randomly assigned to receive bupropion SR (150 to 300 mg daily) or paroxetine (20 to 40 mg daily) under double-blind trial conditions. Patients were assessed at baseline and at 2, 4, 6, and 8 weeks with the 17-item Hamilton Depression Rating Scale (HDRS17), Sex FX, and IRSD-F. Results: Prior to treatment, women reported significantly lower SF on both the Sex FX and IRSD-F scales, compared with men. During treatment, there were no significant drug differences on measures of SF over time for women; however, men who were treated with paroxetine reported a worsening of SF, whereas bupropion SR did not significantly alter SF. Both bupropion SR and paroxetine produced clinically and statistically significant reductions in HDRS17 scores as well as comparable rates of response and remission. There was a statistically significant correlation between the 2 measures of SF at all visits. There was also a significant inverse relation between depression and SF in women, but not in men, irrespective of drug. Conclusion: According to the Sex FX scale, a significant difference in antidepressant-related sexual dysfunction was detected in men, but not women, during treatment with bupropion SR or paroxetine.

scholarly journals Impacts of rTMS on Refractory Depression and Comorbid PTSD Symptoms at a Military Treatment Facility

2020 ◽  
Vol 185 (9-10) ◽  
pp. e1420-e1427
Author(s):  
Sean Wilkes ◽  
Celia Ona ◽  
Michael Yang ◽  
Pingyang Liu ◽  
Amber Benton ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Mixed Model ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Active Duty ◽  
Ptsd Symptoms ◽  
Refractory Depression ◽  
Antidepressant Medications ◽  
Treatment Of Depression ◽  
Changes Over Time ◽  
Over Time

Abstract Introduction Repetitive transcranial magnetic stimulation (rTMS) as a treatment for depression has been studied for over two decades. Repetitive TMS was approved by the Food and Drug Administration in 2008 for the treatment of depression after at least one failed trial of an antidepressant medication of adequate dose and duration. This study evaluated whether rTMS treatments may be associated with measurable improvements in depression and post-traumatic stress disorder (PTSD) symptoms for treated military beneficiaries in Hawaii suffering from depression. It also examined the number of failed medication trials that patients underwent before rTMS treatment. Materials and Methods A retrospective chart review of 77 rTMS patients who received and completed treatment between January 1, 2010 and October 31, 2016 was performed. Under a typical treatment regimen, patients receive rTMS for 6 weeks as well as weekly psychiatric assessments, which included completion of Beck’s Depression Inventory (BDI) and PTSD Checklist (PCL). A mixed model repeated measures analysis was done assuming an autoregressive order one covariance structure to evaluate changes over time. Adjusted analyses were done to assess whether changes over time differed by age, prior diagnosis of PTSD, active duty status, and gender. Results The majority of patients were from the army (74%) and 56% were on active duty. Just over half (53%) were male. Most patients (52%) had completed trials of three or more different antidepressant medications before initiation of treatment with rTMS. The mean number of antidepressant trials was 2.7. BDI and PCL scores were significantly lower at end of treatment on average compared to the pretreatment baseline scores. Mean differences for BDI and PCL were significant with P &lt; 0.001 15, 30, and 45 days after TMS treatment was initiated. Overall, 44% of patients experienced a reduction ≥10 points on BDI, and 38% experienced a reduction ≥10 points on PCL. Additionally, scores fell similarly regardless of whether or not patients had a comorbid diagnosis of PTSD. Conclusions Our research suggests that rTMS treatments may produce a reduction in symptoms of both depression and PTSD in patients with refractory depression and comorbid PTSD. It may be a useful alternative to antidepressants in the treatment of depression in the military population, including those with comorbid PTSD. Broader implementation of this treatment modality may prove beneficial for the purposes of military readiness, given current policies and restrictions on service members who are initiated on antidepressant medications.

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