Celecoxib for the treatment of mild-to-moderate depression due to acute brucellosis: a double-blind, placebo-controlled, randomized trial

Jafari, Sara; Ashrafizadeh, S.-G.; Zeinoddini, Atefeh; Rasoulinejad, Mehrnaz; Entezari, Pouya; Seddighi, Sahar; Akhondzadeh, Shahin

doi:10.1111/jcpt.12287

Cited by 27 publications

(26 citation statements)

References 31 publications

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“…A recent clinical study has shown beneficial effects of anti-inflammatory co-medication with antidepressants in depressed patients with increased levels of peripheral inflammation [16]. This is in line with a study by Raison et al [9] who performed a proof-of-concept study with a TNF antagonist in patients with TRD and showed improvement in patients with high baseline inflammatory biomarkers.…”

Section: Discussionsupporting

confidence: 78%

N-acetylcysteine as add-on to antidepressant medication in therapy refractory major depressive disorder patients with increased inflammatory activity: study protocol of a double-blind randomized placebo-controlled trial

Yang

Bosker

et al. 2018

BMC Psychiatry

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BackgroundA subgroup of depressed patients with increased inflammatory activity was shown to be more susceptible to develop Treatment Resistant Depression (TRD). Earlier studies with anti-inflammatory drugs have shown benefits in the treatment of major depressive disorder (MDD), but the effects are expected to be higher in patients with increased inflammatory activity. Supplementation of N-acetylcysteine (NAC) to ongoing antidepressant therapy may positively influence outcome of depression treatment in these patients. Therefore, this study aims to investigate the efficacy of NAC supplementation in patients with insufficient response to standard antidepressant treatment, and to explore potential roles of inflammation and oxidative stress involved in the alleged pathophysiological processes of TRD.Methods/designA double-blind randomized placebo-controlled study comparing NAC versus placebo as add-on medication to antidepressant treatment with 12-week treatment and 8-week follow up in patients with TRD and increased inflammatory activity. Apart from clinical efficacy defined as the change in Hamilton Depression Rating Scale (HAMD)-17 score, secondary outcomes include changes in pathophysiological mechanisms related to depression as well as changes in local brain activity (functional Magnetic Resonance Imaging, fMRI) and white matter integrity (Diffusion Tensor Imaging, DTI). Importantly, sole patients with CRP levels with values between 0.85 and 10 mg/L will be included.DiscussionThis is the first clinical trial taking both TRD and increased inflammatory activity as inclusion criteria. This study will provide reliable evidence for the efficacy of NAC in patients with TRD displaying increased inflammatory activity. And this study also will help explore further the roles of inflammation and oxidative stress involved in the alleged pathophysiological processes of TRD.Trial registrationThe trial protocol has been registered on “ClinicalTrials.gov“with protocol ID “NAC-2015-TJAH” and ClinicalTrials.gov ID “NCT02972398”.

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Section: Discussionsupporting

confidence: 78%

N-acetylcysteine as add-on to antidepressant medication in therapy refractory major depressive disorder patients with increased inflammatory activity: study protocol of a double-blind randomized placebo-controlled trial

Yang

Bosker

et al. 2018

BMC Psychiatry

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“…). We identified 39 studies covering 44 RCTs with a total of 10 891 individuals: 14 trials ( N = 4451) studied NSAIDs [five add‐ons , eight monotherapy except one trial where 45% of patients were on antidepressant medication ], 12 ( N = 3868) studied cytokine inhibitors [all as monotherapy except for one study where 62% of the patients were treated with antidepressants ], 9 ( N = 2118) studied statins [three add‐ons and six monotherapy ], 3 ( N = 119) studied pioglitazone as add‐on , 3 ( N = 162) studied minocycline [two add‐ons and one monotherapy ], and 3 ( N = 173) studied glucocorticoids as monotherapy . Of these, eight RCTs could not be included since we did not have access to the necessary data, neither published or after contact to the authors.…”

Section: Resultsmentioning

confidence: 99%

Efficacy of anti‐inflammatory treatment on major depressive disorder or depressive symptoms: meta‐analysis of clinical trials

Köhler‐Forsberg

Lydholm

Hjorthøj

et al. 2019

Acta Psychiatr Scand

270

186

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Efficacy of anti-inflammatory treatment on major depressive disorder or depressive symptoms: meta-analysis of clinical trials K€ ohler-Forsberg O, Nicolaisen Lydholm C, Hjorthøj C, Nordentoft C, Mors O, Benros ME. Efficacy of anti-inflammatory treatment on major depressive disorder or depressive symptoms: meta-analysis of clinical trials Background: No study has gathered evidence from all randomized clinical trials (RCTs) with anti-inflammatory drugs measuring antidepressant effects including a detailed assessment of side-effects and bias. Methods: We performed a systematic review identifying RCTs published prior to January 1, 2018, studying antidepressant treatment effects and sideeffects of pharmacological anti-inflammatory intervention in adults with major depressive disorder (MDD) or depressive symptoms. Outcomes were depression scores after treatment, remission, response, and side-effects. Pooled standard mean differences (SMD) and risk ratios (RR) including 95% confidence intervals (95%-CI) were calculated. Results: We identified 36 RCTs, whereof 13 investigated NSAIDs (N = 4214), 9 cytokine inhibitors (N = 3345), seven statins (N = 1576), 3 minocycline (N = 151), 2 pioglitazone (N = 77), and 2 glucocorticoids (N = 59). Anti-inflammatory agents improved depressive symptoms compared to placebo as add-on in patients with MDD (SMD = À0.64; 95%-CI = À0.88, À0.40; I 2 = 51%; N = 597) and as monotherapy (SMD = À0.41; 95%-CI = À0.60, À0.22; I 2 = 93%, N = 8825). Antiinflammatory add-on improved response (RR = 1.76; 95%-CI = 1.44-2.16; I 2 = 16%; N = 341) and remission (RR = 2.14; 95%-CI = 1.03-4.48; I 2 = 57%; N = 270). We found a trend toward an increased risk for infections, and all studies showed high risk of bias. Conclusion: Anti-inflammatory agents improved antidepressant treatment effects. Future RCTs need to include longer follow-up, identify optimal doses and subgroups of patients that can benefit from anti-inflammatory intervention. Summations• Among 36 RCTs including almost 10 000 patients, five out of six anti-inflammatory drugs improved depression scores compared to placebo.• Short-term (i.e., weeks) anti-inflammatory add-on to antidepressants showed improved antidepressant effects in MDD without increasing the risk for side-effects.• The effect size for anti-inflammatory add-on to antidepressants was similar to the effect size of antidepressants alone, indicating the potential clinical benefit. Considerations• Few studies reported on side-effects and all studies were associated with risk of bias.• Few studies investigated biomarkers and none explored specific depressive symptoms to predict better response to anti-inflammatory treatment.• Hence, future studies need to include longer follow-up and measures of inflammation (blood, CSF, and brain scans) to identify subgroups of patients with specific depressive symptoms who could be offered anti-inflammatory treatment.

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“…The HDRS contains 17 questions (on a 3-point or 5-point scale) that assess severity of depressive symptoms. This scale has been applied in many clinical trials in Iran exploring depression therapeutic efficacy [27][28][29][30][31][32]. The primary outcome measure of this trial was to evaluate efficacy of saffron compared to fluoxetine in improving depressive symptoms in postpartum individuals using general linear model repeated measures.…”

Section: Outcomementioning

confidence: 99%

Comparison of Saffron versus Fluoxetine in Treatment of Mild to Moderate Postpartum Depression: A Double-Blind, Randomized Clinical Trial

et al. 2016

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Postpartum depression is a common mental health problem that is associated with maternal suffering. The aim of this double-blind clinical trial was to compare safety and efficacy of saffron and fluoxetine in treatment of mild to moderate postpartum depression. This was a 6-week, double-blind, randomized clinical trial. Subjects were women aged 18-45 years with mild to moderate postpartum depression who had Hamilton Depression Rating Scale (HDRS 17-item) score≤18. Eligible participants were randomized to receive either a capsule of saffron (15 mg capsule) or fluoxetine (20 mg capsule) twice daily for 6 weeks. The primary outcome measure was to evaluate efficacy of saffron compared to fluoxetine in improving depressive symptoms (HDRS score). There was no significant effect for time×treatment interaction on HDRS score [F (4.90, 292.50)=1.04, p=0.37] between the 2 groups. 13 (40.60%) patients in the saffron group experienced complete response (≥50% reduction in HDRS score) compared with 16 (50%) in the fluoxetine group and the difference between the 2 groups was not significant in this regard (p=0.61). Frequency of adverse events was not significantly different between the treatment groups. The results of this study may suggest that saffron is a safe alternative medication for improving depressive symptoms of postpartum depression. Nevertheless, it should be mentioned that the trial is not well powered and should be considered a preliminary study. Therefore, large clinical trials with longer treatment periods and comparison with placebo group would be appropriate for future studies.

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Celecoxib for the treatment of mild-to-moderate depression due to acute brucellosis: a double-blind, placebo-controlled, randomized trial

Abstract: Celecoxib is a safe and effective treatment for depression due to brucellosis when compared with placebo.

Cited by 27 publications

References 31 publications

N-acetylcysteine as add-on to antidepressant medication in therapy refractory major depressive disorder patients with increased inflammatory activity: study protocol of a double-blind randomized placebo-controlled trial

N-acetylcysteine as add-on to antidepressant medication in therapy refractory major depressive disorder patients with increased inflammatory activity: study protocol of a double-blind randomized placebo-controlled trial

Efficacy of anti‐inflammatory treatment on major depressive disorder or depressive symptoms: meta‐analysis of clinical trials

Comparison of Saffron versus Fluoxetine in Treatment of Mild to Moderate Postpartum Depression: A Double-Blind, Randomized Clinical Trial

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