scholarly journals Major depressive disorder: association with vitamin C levels and role of vitamin C supplementation in pharmacotherapy

2021 ◽  
Vol 10 (4) ◽  
pp. 403
Author(s):  
Kohima Aggarwal ◽  
Navyug Raj Singh ◽  
Neeru Bala ◽  
Manjit Singh
Keyword(s):  
Major Depressive Disorder ◽  
Vitamin C ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Severe Disease ◽  
Severity Of Illness ◽  
Open Label ◽  
Major Depressive ◽  
Vitamin C Deficiency ◽  
Sufficient Vitamin

Background: Oxidative stress has a well-documented role in pathophysiology of depression. Decrease in levels of vitamin C, an antioxidant, has also been reported in major depressive patients. This study was conducted to assess the association of vitamin C deficiency with major depressive disorder and any change in clinical response to antidepressant therapy with vitamin C co-administration vis-a-vis baseline vitamin C level status.Methods: This study was a prospective, interventional, parallel, randomized and open label study. Sixty patients diagnosed as a case of major depressive disorder in accordance to ICD-10 criteria were enrolled after taking a written informed consent. Two clinical scales namely Hamilton depression rating scale (HDRS) and clinical global impression- illness severity (CGI-S) scale were used for assessment and monitoring.Results: Vitamin C deficient subjects had relatively severe disease as assessed by HDRS and CGI-S scales. A highly significant (p<0.001) reduction was observed in HDRS and CGI-S scores in vitamin C deficient and insufficient groups with supplementation. A statistically insignificant (p>0.05) reduction was seen in HDRS and CGI-I scores in vitamin C sufficient group while also showing a comparatively milder disease.Conclusions: Vitamin C deficiency was found to have a direct relation with severity of illness, as those patients who had insufficient and sufficient vitamin C levels at recruitment were found to exhibit milder symptoms compared to those who were vitamin C deficient. With treatment, greater improvement was observed in those patients who were deficient at the outset.

Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials

CNS Spectrums ◽  
2018 ◽  
Vol 24 (5) ◽  
pp. 496-506 ◽  
Author(s):  
Sarah Atkinson ◽  
Louise Thurman ◽  
Sara Ramaker ◽  
Gina Buckley ◽  
Sarah Ruta Jones ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Children And Adolescents ◽  
Rating Scale ◽  
Transition Period ◽  
Extension Study ◽  
Open Label ◽  
Major Depressive ◽  
Children’S Depression ◽  
Flexible Dose

ObjectiveTwo similarly designed extension studies evaluated the long-term safety and tolerability of desvenlafaxine for the treatment of children and adolescents with major depressive disorder (MDD). Efficacy was evaluated as a secondary objective.MethodsBoth 6-month, open-label, flexible-dose extension studies enrolled children and adolescents who had completed one of two double-blind, placebo-controlled, lead-in studies. One lead-in study included a 1-week transition period prior to the extension study. Patients received 26-week treatment with flexible-dose desvenlafaxine (20–50 mg/d). Safety assessments included comprehensive psychiatric evaluations, vital sign assessments, laboratory evaluations, 12-lead electrocardiogram, physical examination with Tanner assessment, and Columbia-Suicide Severity Rating Scale. Adverse events (AEs) were collected throughout the studies. Efficacy was assessed using the Children’s Depression Rating Scale–Revised (CDRS-R).ResultsA total of 552 patients enrolled (completion rates: 66.4 and 69.1%). AEs were reported by 79.4 and 79.1% of patients in the two studies; 8.9 and 5.2% discontinued due to AEs. Treatment-emergent suicidal ideation or behavior was reported for 16.6 and 14.1% of patients in the two studies. Mean (SD) CDRS-R total score decreased from 33.83 (11.93) and 30.92 (10.20) at the extension study baseline to 24.31 (7.48) and 24.92 (8.45), respectively, at week 26.ConclusionDesvenlafaxine 20 to 50 mg/d was generally safe and well tolerated with no new safety signals identified in children and adolescents with MDD who received up to 6 months of treatment in these studies. Patients maintained the reduction in severity of depressive symptoms observed in all treatment groups at the end of the lead-in study.

Effectiveness of mirtazapine as add-on to paroxetine v. paroxetine or mirtazapine monotherapy in patients with major depressive disorder with early non-response to paroxetine: a two-phase, multicentre, randomized, double-blind clinical trial

2020 ◽  
pp. 1-9 ◽  
Author(s):  
Le Xiao ◽  
Xuequan Zhu ◽  
Amy Gillespie ◽  
Yuan Feng ◽  
Jingjing Zhou ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Additional Treatment ◽  
Combination Group ◽  
Open Label ◽  
Major Depressive ◽  
Double Blind ◽  
Early Improvement

Abstract Background This study aimed to examine the efficacy of combining paroxetine and mirtazapine v. switching to mirtazapine, for patients with major depressive disorder (MDD) who have had an insufficient response to SSRI monotherapy (paroxetine) after the first 2 weeks of treatment. Methods This double-blind, randomized, placebo-controlled, three-arm study recruited participants from five hospitals in China. Eligible participants were aged 18–60 years with MDD of at least moderate severity. Participants received paroxetine during a 2-week open-label phase and patients who had not achieved early improvement were randomized to paroxetine, mirtazapine or paroxetine combined with mirtazapine for 6 weeks. The primary outcome was improvement on the Hamilton Rating Scale for Depression 17-item (HAMD-17) scores 6 weeks after randomization. Results A total of 204 patients who showed early non-response to paroxetine monotherapy were randomly assigned to receive either mirtazapine and placebo (n = 68), paroxetine and placebo (n = 68) or mirtazapine and paroxetine (n = 68), with 164 patients completing the outcome assessment. At week 8, the least squares (LS) mean change of HAMD-17 scores did not significantly differ among the three groups, (12.98 points) in the mirtazapine group, (12.50 points) in the paroxetine group and (13.27 points) in the mirtazapine plus paroxetine combination group. Participants in the paroxetine monotherapy group were least likely to experience adverse effects. Conclusions After 8 weeks follow-up, paroxetine monotherapy, mirtazapine monotherapy and paroxetine/mirtazapine combination therapy were equally effective in non-improvers at 2 weeks. The results of this trial do not support a recommendation to routinely offer additional treatment or a switch in treatment strategies for MDD patients who do not show early improvement after 2 weeks of antidepressant treatment.

scholarly journals Measures of suicidality in phase 3 clinical trials of levomilnacipran ER in adults with major depressive disorder

CNS Spectrums ◽  
2017 ◽  
Vol 22 (6) ◽  
pp. 475-483 ◽  
Author(s):  
Michael E. Thase ◽  
Carl Gommoll ◽  
Changzheng Chen ◽  
Kenneth Kramer ◽  
Arif Khan ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Suicidal Ideation ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Short Term ◽  
Open Label ◽  
Major Depressive ◽  
Double Blind ◽  
And Behavior

ObjectiveTo evaluate the effects of levomilnacipran extended-release (ER) on suicidal ideation and behavior in adults with major depressive disorder (MDD).MethodsPost hoc analyses were conducted in patients from 4 randomized, double-blind, placebo-controlled trials and a long-term, open-label extension study of levomilnacipran ER (40-120 mg/d) in adults with MDD. Analyses included incidence of suicide-related treatment-emergent adverse events (TEAEs); incidence of Columbia–Suicide Severity Rating Scale (C-SSRS) suicidal ideation (score=1–5) and behavior (score=6-10); percent of patients who shifted from no C-SSRS suicidal ideation/behavior at baseline to suicidal ideation during treatment (worsened from score=0 to score=1–5), or vice-versa (improved from score=1-5 to score=0).ResultsSuicide-related TEAEs occurred in<1% of patients in the levomilnacipran ER studies. The incidence of C-SSRS suicidal ideation was 22.2%, 23.9%, and 21.7% for placebo, short-term levomilnacipran ER, and long-term levomilnacipran ER, respectively; C-SSRS suicidal behavior was<1% in all of these groups. In the short-term studies, the percentage of patients with C-SSRS shifts were as follows: worsening from score=0 to score=1–5 (placebo, 8.6%; levomilnacipran ER, 11.0%); improvement from score=1–5 to score=0 (placebo, 24.0%; levomilnacipran ER, 27.7%).ConclusionIn adult MDD patients, the incidence of suicidal ideation and behavior was similar between placebo and short-term levomilnacipran ER as indicated by TEAE reports and C-SSRS scores. Worsening in C-SSRS scores was also similar between placebo and levomilnacipran ER. There was no indication of increased suicidality during longer courses of continued therapy. Together, these findings suggest that this medication is not associated with increased risks of suicidal ideation or behavior.

Modafinil Augmentation of SSRI Therapy in Patients with Major Depressive Disorder and Excessive Sleepiness and Fatigue: A 12-Week, Open-label, Extension Study

CNS Spectrums ◽  
2006 ◽  
Vol 11 (2) ◽  
pp. 93-102 ◽  
Author(s):  
Michael E. Thase ◽  
Maurizio Fava ◽  
Charles DeBattista ◽  
Sanjay Arora ◽  
Rod J. Hughes
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Clinical Global Impression ◽  
Rating Scale ◽  
Extension Study ◽  
Dose Titration ◽  
Open Label ◽  
Major Depressive ◽  
Residual Symptoms ◽  
Excessive Sleepiness

AbstractIntroduction:Many patients with major depressive disorder (MDD) treated with selective serotonin reuptake inhibitors have residual symptoms (eg, persistent fatigue, excessive sleepiness) despite an overall antidepressant response. Placebo-controlled studies indicate that modafinil, a wake-promoting agent, may relieve residual symptoms.Methods:This 12-week, open-label, dose titration, extension study followed an 8-week placebo-controlled study of modafinil augmentation in patients with MDD. The dose was 100–400 mg/day. The median stable dose was 300 mg/day. Assessments were the Epworth Sleepiness Scale, Brief Fatigue Inventory, Clinical Global Impression of Improvement scale, 17-item Hamilton Rating Scale for Depression, and Montgomery-Åsberg Depression Rating Scale.Results:Of the 245 patients treated, 194 completed the study; 70% reported Clinical Global Impression of Improvement scale responses of “much improved” or “very much improved” between open-label baseline and final visit (previous randomized modafinil group: 74%; placebo group: 66%). When data were analyzed for four subsets of patients (former modafinil responders, placebo responders, modafinil nonresponders, and placebo nonresponders), improvements in scores on all outcome measures were at least twice as great among former modafinil and placebo nonresponders compared with responders. Most common adverse events were headache (18%), nausea (9%), and dizziness (7%); all were generally mild to moderate in severity.Conclusion:Twelve weeks of modafinil augmentation relieved excessive sleepiness, reduced fatigue, and improved patients' overall clinical condition, including mood.

scholarly journals Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e056091
Author(s):  
James Rucker ◽  
Hassan Jafari ◽  
Tim Mantingh ◽  
Catherine Bird ◽  
Nadav Liam Modlin ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Informed Consent ◽  
Depressive Disorder ◽  
Primary Outcome ◽  
Rating Scale ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Feasibility Trial ◽  
Open Label ◽  
Major Depressive

IntroductionPsilocybin-assisted therapy may be a new treatment for major depressive disorder (MDD), with encouraging data from pilot trials. In this trial (short name: PsiDeR) we aimed to test the feasibility of a parallel-group, randomised, placebo-controlled design. The primary outcomes in this trial are measures of feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression.Methods and analysisWe are recruiting up to 60 participants at a single centre in London, UK who are unresponsive to, or intolerant of, at least two evidence-based treatments for MDD. Participants are randomised to receive a single dosing session of 25 mg psilocybin or a placebo. All participants receive a package of psychological therapy. The primary outcome measure for depression is the Montgomery Asberg Depression Rating Scale collected by blinded, independent raters. The primary endpoint is at 3 weeks, and the total follow-up is 6 weeks. With further informed consent, this study collects neuroimaging and omics data for mechanism and biomarker analyses and offers participants an open label extension consisting of a further, open label dose of 25 mg of psilocybin.Ethics and disseminationAll participants will be required to provide written informed consent. The trial has been authorised by the National Research Ethics Committee (20-LO/0206), Health Research Authority (252750) and Medicine’s and Healthcare Products Regulatory Agency (CTA 14523/0284/001-0001) in the UK. Dissemination of results will occur via a peer-reviewed publication and other relevant media.Trial registration numbersEUDRACT2018-003573-97; NCT04959253.

scholarly journals Effects of chronic l-theanine administration in patients with major depressive disorder: an open-label study

2016 ◽  
Vol 29 (2) ◽  
pp. 72-79 ◽  
Author(s):  
Shinsuke Hidese ◽  
Miho Ota ◽  
Chisato Wakabayashi ◽  
Takamasa Noda ◽  
Hayato Ozawa ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Cognitive Functions ◽  
Verbal Memory ◽  
Rating Scale ◽  
Stroop Test ◽  
Open Label ◽  
Major Depressive ◽  
Open Label Study ◽  
Label Study

Objectivel-theanine, an amino acid uniquely contained in green tea (Camellia sinensis), has been suggested to have various psychotropic effects. This study aimed to examine whether l-theanine is effective for patients with major depressive disorder (MDD) in an open-label clinical trial.MethodsSubjects were 20 patients with MDD (four males; mean age: 41.0±14.1 years, 16 females; 42.9±12.0 years). l-theanine (250 mg/day) was added to the current medication of each participant for 8 weeks. Symptoms and cognitive functions were assessed at baseline, 4, and 8 weeks after l-theanine administration by the 21-item version of the Hamilton Depression Rating Scale (HAMD-21), State-Trait Anxiety Inventory (STAI), Pittsburgh Sleep Quality Index (PSQI), Stroop test, and Brief Assessment of Cognition in Schizophrenia (BACS).ResultsHAMD-21 score was reduced after l-theanine administration (p=0.007). This reduction was observed in unremitted patients (HAMD-21>7; p=0.004) at baseline. Anxiety-trait scores decreased after l-theanine administration (p=0.012) in the STAI test. PSQI scores also decreased after l-theanine administration (p=0.030) in the unremitted patients at baseline. Regarding cognitive functions, response latency (p=0.001) and error rate (p=0.036) decreased in the Stroop test, and verbal memory (p=0.005) and executive function (p=0.016) were enhanced in the BACS test after l-theanine administration.ConclusionOur study suggests that chronic (8-week) l-theanine administration is safe and has multiple beneficial effects on depressive symptoms, anxiety, sleep disturbance and cognitive impairments in patients with MDD. However, since this is an open-label study, placebo-controlled studies are required to consolidate the effects.

scholarly journals 111 A Novel Dual-Channel Deep Transcranial Magnetic Stimulator for Major Depressive Disorder

CNS Spectrums ◽  
2018 ◽  
Vol 23 (1) ◽  
pp. 71-72 ◽  
Author(s):  
Eiran V Harel ◽  
Dikla Shmuel ◽  
Daniel Antler ◽  
Dana Katz ◽  
Elina Pushkarski ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Open Label ◽  
Major Depressive ◽  
Dual Channel ◽  
Randomized Controlled Studies ◽  
Number Of Patients ◽  
Initial Score ◽  
The Right

AbstractBackgroundRepetitive deep transcranial magnetic stimulation (dTMS) is efficacious for treatment resistant major depressive disorder (TRD) with the H1 coil by stimulating the prefrontal cortex, left more than right, at high frequency. Theoretically, the efficacy of dTMS could be optimized by simultaneously stimulating the right and left lateral prefrontal cortices (PFC) with different frequencies. This study tested the efficacy of a novel dual-channel dTMS stimulator with dual dTMS coils, in patients with TRD.MethodsThis study recruited forty-seven outpatients diagnosed with TRD, age 18-65, Hamilton Depression Rating Scale (HDRS-21) score ≥25. Each patient received 20 open label treatment sessions, five days a week for 4 consecutive weeks. Treatments were administered with the dual-channel stimulator (Brainsway Multiway dTMS device) using two channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. Primary and secondary efficacy outcome measures were the change in HDRS-21 score and response/remission rates at week 5, respectively.ResultsThe HDRS-21 score decreased from an average of 25.94 to 14.69 (P<0.001). Thirty-six patients completed four weeks of treatment. Of them, seventeen (47%) responded (HDRS-21 score decrease of ≥ 50% from their initial score) and eight (22%) remitted (HDRS-21 score of < 10 at the end of the study).DiscussionThis open study shows promising results for multichannel simultaneous dTMS treatment of TRD using the Brainsway Multiway Device. Further randomized controlled studies are necessary to aid the high number of patients with TRD.Funding AcknowledgementsBrainsway Ltd.

scholarly journals Efficacy of Buspirone Augmentation of Escitalopram in Patients with Major Depressive Disorder with and without Atypical Features: A Randomized, 8 Week, Multicenter, Open-Label Clinical Trial

2020 ◽  
Vol 17 (8) ◽  
pp. 796-803
Author(s):  
Cheolmin Shin ◽  
Young-Hoon Ko ◽  
Se-Hoon Shim ◽  
Ji Sun Kim ◽  
Kyoung-Sae Na ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Cognitive Function ◽  
Depressive Disorder ◽  
Cognitive Enhancement ◽  
Rating Scale ◽  
Digit Span ◽  
Word Fluency ◽  
Open Label ◽  
Major Depressive ◽  
Atypical Features

Objective This study investigated the treatment response and cognitive enhancement effects of buspirone augmentation of escitalopram in patients with major depressive disorder (MDD), according to atypical feature subtypes of MDD.Methods An 8 week, randomized, parallel-controlled, open-label study was conducted. The Columbia Atypical Depression Diagnostic Scale was administered to evaluate atypical features. Patients were assigned randomly to the buspirone augmentation or non-buspirone groups. Symptom severity and cognitive function were evaluated using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Beck Depression Inventory, Beck Anxiety Inventory, digit span test, word fluency test, and Trail Making Tests A and B.Results A total of 89 patients were recruited. There were no significant differences in the measures between the groups; however, among the MDD patients without atypical features, the digit span and word fluency tests were improved by treatment. In the MDD patients without atypical features, the buspirone augmentation group showed a significant improvement on the digit span test compared to the non-buspirone group.Conclusion Buspirone augmentation did not demonstrate significant benefits in MDD patients; however, buspirone augmentation showed greater efficacy for the improvement of cognitive function in MDD patients without atypical features. Our study suggests that atypical features are an important factor for cognitive enhancement in buspirone augmentation treatment in patients with MDD.

scholarly journals Predictors of Suicidal Ideation and Attempt among Patients with Major Depressive Disorder at a Tertiary Care Hospital, Puducherry

2021 ◽  
Vol 12 (01) ◽  
pp. 122-128
Author(s):  
Ralte Lalthankimi ◽  
Padmavathi Nagarajan ◽  
Vikas Menon ◽  
Jeby Jose Olickal
Keyword(s):  
Major Depressive Disorder ◽  
Suicidal Ideation ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Tertiary Care ◽  
Severe Depression ◽  
Care Hospital ◽  
Suicidal Behaviors ◽  
Major Depressive ◽  
Severity Of Depression

Abstract Objectives Mental disorders have a large impact on death by suicide. Hence, this study aims to determine the prevalence of suicidal behaviors among major depressive disorder (MDD) patients and the associated factors. Materials and Methods This cross-sectional analytical study was conducted among individuals aged 18 to 65 years, diagnosed with MDD in the Psychiatry Outpatient Department of a Tertiary Care Center, Puducherry during March to October 2019. Severity of depression was assessed using Hamilton Depression Rating Scale and Columbia-Suicide Severity Rating Scale was used to find the suicidal behaviors. Results For 166 participants in the study, mean (standard deviation) age was 40 (11) years and majority were females (76%). More than one-third (37%) had severe or very severe depression, and the prevalence of suicidal ideation, plan, and attempts were 83, 24, and 35%, respectively. After adjusting the covariates, the severity of depression and unemployment were significantly associated with suicidal attempts (adjusted prevalence ratios [aPR] = 11.4 and 1.9), and very severe depression was associated with suicidal ideation (aPR = 1.6). Among 140 individuals with suicidal ideation, 45 (32%) had an ideation frequency of 2 to 3 times/week, 69 (50%) had ideation for 1 hour, 36 (26%) could control ideation with little difficulty, and 12% had suicidal ideation mostly to end or stop their pain. Conclusion Suicidal ideation and attempts were significantly high in MDD patients, and the severity of depression was significantly associated with it. Early identification of high-risk suicidal behavior and implementation of effective preventive interventions are necessary to reduce death by suicide in these groups.

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