Incidental endometrial cancer detected on FDG PET/CT imaging for melanoma.

This case report follows a 66-year-old female who originally presented with malignant melanoma in the left knee and recurrence in the left inguinal region. This prompted a whole body FDG PET/CT scan which showed incidental focal hypermetabolism in the uterus. The diagnosis of endometrial cancer was confirmed at biopsy, and the patient was treated with total abdominal hysterectomy. Melanoma patients are at increased risk of second primary malignancy, and endometrial cancer is a common second primary often diagnosed in cancer survivors. Incidental endometrial focal hypermetabolism should be investigated further for a synchronous malignancy, especially in a post-menopausal woman.

Synchronous Endometrial Cancer Detected on 68 Ga-DOTATATE PET/CT.

ABSTRACT: A 50-year-old woman with history of metastatic neuroendocrine tumor underwent a follow-up PET/CT with 68 Ga-DOTATATE. An enlarged uterus with diffuse increased uptake warranted further investigation with an MRI that showed mass-like thickening of the endometrium, T2 hyperintensity, lobulated contour, and invasion of more than 50% of the myometrium. Biopsy revealed endometrial carcinoma with mucinous features. Mild to moderate uptake of the 68 Ga-DOTATATE by the uterus can be a normal physiological finding; however, it should prompt further investigation, particularly in a postmenopausal woman with concerning imaging or clinical findings.

Utility of an automatic adaptive iterative metal artifact reduction AiMAR algorithm in improving CT imaging of patients with hip prostheses evaluated for suspected bladder malignancy.

PURPOSE: To compare the utility of a novel metal artifact reduction algorithm to standard imaging in improving visualization of key structures, diagnostic confidence, and patient-level confidence in malignancy in patients with suspected bladder cancer. METHODS: Patients with hip implants undergoing CT urography for suspected bladder malignancy were enrolled. Images were reconstructed using 3 methods: (1) Filtered Back Projection (FBP), (2) Iterative Metal Artifact Reduction (iMAR), and (3) Adaptive Iterative Metal Artifact Reduction (AiMAR) strength 4. In multiple reading sessions, three radiologists graded visualization of critical anatomic structures and artifact severity (6-point scales, lower scores desirable), and diagnostic confidence in blinded fashion. They also graded patient-level confidence in malignancy based on imaging findings in each patient. RESULTS: Thirty-two patients (8 females) with a mean age of 74.5 ± 8.5 years were included. The median (range) visualization scores for FBP, iMAR, and AiMAR were 3.6 (1.1-4.9), 1.6 (0.3-2.8), and 1.6 (0.3-2.6), respectively. Both iMAR and AiMAR had anatomic visualization and artifact scores better than FBP (P < 0.001 for both) and similar to each other (P > 0.05). Structures with the most improvement in visualization score with the use of metal artifact reduction algorithms included the obturator internus muscle, internal and external iliac nodal chains, and vagina. iMAR and AiMAR improved diagnostic confidence (P < 0.001) and patient-level confidence in malignancy (P ≤ 0.24). CONCLUSION: For patients with hip prostheses and suspected bladder malignancy, the use of iMAR or AiMAR was shown to significantly reduce metal artifacts, thus improving diagnostic confidence and patient-level confidence in malignancy.

CT Noise-Reduction Methods for Lower-Dose Scanning: Strengths and Weaknesses of Iterative Reconstruction Algorithms and New Techniques.

Iterative reconstruction (IR) algorithms are the most widely used CT noise-reduction method to improve image quality and have greatly facilitated radiation dose reduction within the radiology community. Various IR methods have different strengths and limitations. Because IR algorithms are typically nonlinear, they can modify spatial resolution and image noise texture in different regions of the CT image; hence traditional image-quality metrics are not appropriate to assess the ability of IR to preserve diagnostic accuracy, especially for low-contrast diagnostic tasks. In this review, the authors highlight emerging IR algorithms and CT noise-reduction techniques and summarize how these techniques can be evaluated to help determine the appropriate radiation dose levels for different diagnostic tasks in CT. In addition to advanced IR techniques, we describe novel CT noise-reduction methods based on convolutional neural networks (CNNs). CNN-based noise-reduction techniques may offer the ability to reduce image noise while maintaining high levels of image detail but may have unique drawbacks. Other novel CT noise-reduction methods are being developed to leverage spatial and/or spectral redundancy in multiphase or multienergy CT. Radiologists and medical physicists should be familiar with these different alternatives to adapt available CT technology for different diagnostic tasks. The scope of this article is (a) to review the clinical applications of IR algorithms as well as their strengths, weaknesses, and methods of assessment and (b) to explore new CT image reconstruction and noise-reduction techniques that promise to facilitate radiation dose reduction. ©RSNA, 2021.

The utility of a dual-phase, dual-energy CT protocol in patients presenting with overt gastrointestinal bleeding.

BACKGROUND: Due to their easy accessibility, CT scans have been increasingly used for investigation of gastrointestinal (GI) bleeding. PURPOSE: To estimate the performance of a dual-phase, dual-energy (DE) GI bleed CT protocol in patients with overt GI bleeding in clinical practice and examine the added value of portal phase and DE images. MATERIALS AND METHODS: Consecutive patients with GI bleeding underwent a two-phase DE GI bleed CT protocol. Two gastroenterologists established the reference standard. Performance was estimated using clinical CT reports. Three GI radiologists rated confidence in GI bleeding in a subset of 62 examinations, evaluating first mixed kV arterial images, then after examining additional portal venous phase images, and finally after additional DE images (virtual non-contrast and virtual monoenergetic 50 keV images). RESULTS: 52 of 176 patients (29.5%) had GI bleeding by the reference standard. The overall sensitivity, specificity, and positive and negative predictive values of the CT GI bleed protocol for detecting GI bleeding were 65.4%, 89.5%, 72.3%, and 86.0%, respectively. In patients with GI bleeding, diagnostic confidence of readers increased after adding portal phase images to arterial phase images (p = 0.002), without additional benefit from dual energy images. In patients without GI bleeding, confidence in luminal extravasation appropriately decreased after adding portal phase, and subsequently DE images (p = 0.006, p = 0.018). CONCLUSION: A two-phase DE GI bleed CT protocol had high specificity and negative predictive value in clinical practice. Portal venous phase images improved diagnostic confidence in comparison to arterial phase images alone. Dual-energy images further improved radiologist confidence in the absence of bleeding.

MRI-detected extramural venous invasion of rectal cancer: Multimodality performance and implications at baseline imaging and after neoadjuvant therapy.

MRI is routinely used for rectal cancer staging to evaluate tumor extent and to inform decision-making regarding surgical planning and the need for neoadjuvant and adjuvant therapy. Extramural venous invasion (EMVI), which is intravenous tumor extension beyond the rectal wall on histopathology, is a predictor for worse prognosis. T2-weighted images (T2WI) demonstrate EMVI as a nodular-, bead-, or worm-shaped structure of intermediate T2 signal with irregular margins that arises from the primary tumor. Correlative diffusion-weighted images demonstrate intermediate to high signal corresponding to EMVI, and contrast enhanced T1-weighted images demonstrate tumor signal intensity in or around vessels. Diffusion-weighted and post contrast images may increase diagnostic performance but decrease inter-observer agreement. CT may also demonstrate obvious EMVI and is potentially useful in patients with a contraindication for MRI. This article aims to review the spectrum of imaging findings of EMVI of rectal cancer on MRI and CT, to summarize the diagnostic accuracy and inter-observer agreement of imaging modalities for its presence, to review other rectal neoplasms that may cause EMVI, and to discuss the clinical significance and role of MRI-detected EMVI in staging and restaging clinical scenarios.

Automated radiomic analysis of CT images to predict likelihood of spontaneous passage of symptomatic renal stones.

PURPOSE: To evaluate the ability of a semi-automated radiomic analysis software in predicting the likelihood of spontaneous passage of urinary stones compared with manual measurements. METHODS: Symptomatic patients visiting the emergency department with suspected stones in either kidney or ureters who underwent a CT scan were included. Patients were followed for up to 6 months for the outcome of a trial of passage. Maximum stone diameters in axial and coronal images were measured manually. Stone length, width, height, max diameter, volume, the mean and standard deviation of the Hounsfield units, and morphologic features were also measured using automated radiomic analysis software. Multivariate models were developed using these data to predict subsequent spontaneous stone passage, with results expressed as the area under a receiver operating curve (AUC). RESULTS: One hundred eighty-four patients (69 females) with a median age of 56 years were included. Spontaneous stone passage occurred in 114 patients (62%). Univariate analysis demonstrated an AUC of 0.83 and 0.82 for the maximum stone diameter determined manually in the axial and coronal planes, respectively. Multivariate models demonstrated an AUC of 0.82 for a model including manual measurement of maximum stone diameter in axial and coronal planes. The same AUC was found for a model including automatic measurement of maximum height and diameter of the stone. Further addition of morphological parameters measured automatically did not increase AUC beyond 0.83. CONCLUSION: The semi-automated radiomic analysis of urinary stones shows similar accuracy compared with manual measurements for predicting urinary stone passage. Further studies are needed to predict clinical impacts of reporting the likelihood of urinary stone passage and improving inter-observer variation using automatic radiomic analysis software.

Benefits of iterative metal artifact reduction and dual-energy CT towards mitigating artifact in the setting of total shoulder prostheses.

OBJECTIVE: To determine the utility of iterative metal artifact reduction and 130 keV dual-energy virtual monoenergetic images to improve bone and soft tissue visualization in CT scans affected by metal artifacts. MATERIAL AND METHODS: Thirteen females and 6 males with a history of total shoulder prosthesis who underwent dual-energy shoulder CT were included. Four sets of images were reconstructed for each patient: (1) original polychromatic kV images reconstructed with weighted filtered back projection; (2) polychromatic kV images with iterative metal artifact reduction; (3) 130 keV dual-energy virtual monoenergetic; (4) combined iterative metal artifact reduction and 130 keV dual-energy virtual monoenergetic. Three readers blindly reviewed all image sets and graded the extent of artifact and image quality. RESULTS: Mean artifact score and median overall image quality score were better in 130 keV dual-energy virtual monoenergetic with iterative metal artifact reduction compared with those in original polychromatic kV images (3.02 vs 4.28, P < 0.001 and 3.00 vs 4.33, P < 0.001, respectively). The median difference in CT numbers between regions affected by artifacts and normal regions was lowest in 130 keV dual-energy virtual monoenergetic with iterative metal artifact reduction compared with that in original polychromatic kV images (72.28 vs 252.08, P < 0.001 for bony regions and 15.09 vs 324.38, P < 0.001 for soft tissue). CONCLUSION: In patients with metal artifacts due to shoulder replacement surgery, the use of dual-energy monoenergetic images and iterative metal artifact reduction reconstruction significantly improves both subjective and objective indicators of image quality.

Ultrasound for Intubation Confirmation: A Randomized Controlled Study among Emergency Medicine Residents.

Confirmation of endotracheal tube (ETT) placement during intubation is a critical skill for emergency medicine (EM) residents; airway ultrasonography has been suggested as an accessible and accurate method of ETT confirmation. Here, we investigated the accuracy with which EM residents could identify ETT location in cadavers using different ultrasound modes. EM attendings intubated either the trachea or the esophagus of a cadaver, and blinded residents identified ETT position using either B-mode or B-mode plus color Doppler. Residents correctly identified ETT location in 1075 of 1203 trials (89.4%); performance improved with post-graduate year (residents in post-graduate year 3 had 97.8% accurate identifications). There were 556 (91.7%) correct identifications made with B-mode and 519 (86.9%) with B-mode plus color Doppler (p value = 0.007); thus, accuracy did not improve with addition of color Doppler to B-mode. Further research is needed on the efficacy of different ultrasound modes in confirming ETT placement in live intubations.

Prior iterative reconstruction (PIR) to lower radiation dose and preserve radiologist performance for multiphase liver CT: a multi-reader pilot study.

PURPOSE: Prior iterative reconstruction (PIR) spatially registers CT image data from multiple phases of enhancement to reduce image noise. We evaluated PIR in contrast-enhanced multiphase liver CT. METHODS: Patients with archived projection CT data with proven malignant or benign liver lesions, or without lesions, by reference criteria were included. Lower-dose PIR images were reconstructed using validated noise insertion from multiphase CT exams (50% dose in 2 phases, 25% dose in 1 phase). The phase of enhancement most relevant to the diagnostic task was selected for evaluation. Four radiologists reviewed routine-dose and lower-dose PIR images, circumscribing liver lesions and rating confidence for malignancy (0 to 100) and image quality. JAFROC Figures of Merit (FOM) were calculated. RESULTS: 31 patients had 60 liver lesions (28 primary hepatic malignancies, 6 hepatic metastases, 26 benign lesions). Pooled JAFROC FOM for malignancy for routine-dose CT was 0.615 (95% CI 0.464, 0.767) compared to 0.662 for PIR (95% CI 0.527, 0.797). The estimated FOM difference between the routine-dose and lower-dose PIR images was + 0.047 (95% CI - 0.023, + 0.116). Pooled sensitivity/specificity for routine-dose images was 70%/68% compared to 73%/66% for lower-dose PIR. Lower-dose PIR had lower diagnostic image quality (mean 3.8 vs. 4.2, p = 0.0009) and sharpness (mean 2.3 vs. 2.0, p = 0.0071). CONCLUSIONS: PIR is a promising method to reduce radiation dose for multiphase abdominal CT, preserving observer performance despite small reductions in image quality. Further work is warranted.

A New Formula for Confirmation of Proper Endotracheal Tube Placement with Ultrasonography.

BACKGROUND: Endotracheal intubation is an important procedure in critical care and emergency medicine settings. Optimal depth of the tube placement has been a serious concern because of several complications associated with its malposition. OBJECTIVE: The aim of the current study was to find a new formula to estimate the proper endotracheal tube depth when using ultrasonography or lighted stylet device in order to increase the accuracy of determining Endotracheal tube (ETT) depth and decrease the side effects of ETT misplacement. METHOD: Patients older than 18 years of age admitted to Imam emergency department who needed tracheal intubation were included. Tube's length at the angle of the mouth while the tube passed the suprasternal notch, ETT depth after insertion and the distance from ETT's tip to carina were recorded. Ultrasonography and portable chest x-ray were used as tools for measuring these lengths. RESULTS: A total number of 91 patients including 55 men and 36 women were eligible for inclusion in the study. Not placing the tube at proper depth was considered as the failure of intubation. This failure rate was 9.9% in the standard method which would have been 1.1% if our proposed formula was used. CONCLUSION: The findings of this study suggest that the use of this new formula may help in predicting the proper intubation tube placement. Further studies are warranted to confirm these findings.

A new modality for the estimation of corrected flow time via electrocardiography as an alternative to Doppler ultrasonography.

BACKGROUND: Evaluation of corrected flow time (FTc) via ultrasonography is one of the suggested modalities for the assessment of intravascular volume status. This study aimed to compare the results of FTc of carotid artery measured via ultrasonography, as a measure of mechanical outcome of the cardiac cycle, with the results of FTc estimation from a new modified formula via electrocardiography (ECG), as a measure of electrical function of the cardiac cycle. METHODS: Healthy volunteers were evaluated before and after a passive leg raising (PLR) maneuver. FTc was measured concurrently before and after PLR via a modified method from ECG and via ultrasonography of the carotid artery. RESULTS: A total number of 98 healthy volunteers (51 women and 47 men) with a mean age of 30.69 ± 6.28 years were included. There was a significant correlation between FTc measured by ultrasonography and estimated by ECG both before PLR and after PLR (r = .878, p < .0001 and r = .797, p < .0001, respectively). Changes in FTc were slightly higher in measurements by ultrasonography compared to estimations by ECG (22.33 ± 17.15 ms0.5 vs. 15.86 ± 14.25 ms0.5 , p = .001). CONCLUSION: Estimation of FTc via ECG is potentially an effective and feasible method for the assessment of volume status at the clinical settings. Further investigations should determine the significance of differences that may be observed between ultrasonography and ECG in patients with either dehydration or volume overload and in the need of real-time volume status assessment.

Comparison of Saffron and Fluvoxamine in the Treatment of Mild to Moderate Obsessive-Compulsive Disorder: A Double Blind Randomized Clinical Trial.

Objective: There are different pathophysiological mechanisms for obsessive- compulsive disorder (OCD) as suggested by the serotonergic, dopaminergic, and glutamatergic hypotheses. The present study aimed at comparing the efficacy and safety of saffron (stigma of Crocus sativus) and fluvoxamine in the treatment of mild to moderate obsessive- compulsive disorder. Method: In this study, 50 males and females, aged 18 to 60 years, with mild to moderate OCD, participated. The patients were randomly assigned to receive either saffron (30 mg/day, 15 mg twice a day) or fluvoxamine (100 mg/day) for 10 weeks. Using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Adverse Event Checklist, we assessed the patients at baseline, and at the second, fourth, sixth, eighth, and tenth week. Finally, the data were analyzed using general linear repeated measures. Results: In this study, 46 patients completed the trial. General linear repeated measures demonstrated no significant effect for time-treatment interaction on the Y-BOCS total scores [F (2.42, 106.87) = 0.70, P = 0.52], obsession Y-BOCS subscale scores [F (2.47, 108.87) = 0.77, p = 0.49], and compulsion Y-BOCS subscale scores [F (2.18, 96.06) = 0.25, P = 0.79]. Frequency of adverse events was not significantly different between the 2 groups. Conclusion: Our findings suggest that saffron is as effective as fluvoxamine in the treatment of patients with mild to moderate OCD.

Cilostazol adjunctive therapy in treatment of negative symptoms in chronic schizophrenia: Randomized, double-blind, placebo-controlled study.

OBJECTIVE: To evaluate the efficacy and safety of cilostazol, a selective inhibitor of phosphodiesterase III, as an adjunctive to risperidone in alleviating the negative symptoms of schizophrenia. METHODS: Eighty-four in-patients with diagnosis of chronic schizophrenia participated in a randomized, placebo-controlled trial and underwent 8 weeks of treatment with either cilostazol (50 mg twice a day) or placebo as an adjuvant to risperidone. Participants were assessed using the positive and negative syndrome scale (PANSS) at baseline and at weeks 2, 4, 6, and 8. The primary outcome measure of the trial was to evaluate the efficacy of cilostazol compared to placebo in improving the PANSS negative subscale score. RESULT: General linear model repeated measures demonstrated significant effect for time × treatment interaction on negative subscale scores (p < .001) and PANSS total (p = .006) but did not demonstrate significant effect on the PANSS positive (p = .37) and general (p = .06) subscales. Frequency of adverse events was not significantly different between the 2 treatment groups. No serious adverse event was observed. CONCLUSION: An 8-week course of treatment with cilostazol as an adjunct to risperidone showed a favorable safety and efficacy profile in patients with schizophrenia.

A Randomized, Double-Blind Placebo-Controlled Trial on Effectiveness and Safety of Celecoxib Adjunctive Therapy in Adolescents with Acute Bipolar Mania.

OBJECTIVE: Recent studies have focused on the role of inflammatory cascades as one of the possible etiologic factors of bipolar disorder. We hypothesize that celecoxib, through its anti-inflammatory properties, may have a therapeutic role in acute bipolar mania. PATIENTS AND METHODS: Forty-two adolescent inpatients with the diagnosis of acute bipolar mania participated in a parallel, randomized, double-blind controlled trial, and 40 patients underwent an 8-week treatment with either celecoxib (100 mg twice daily) or placebo as an adjunctive treatment to lithium and risperidone. Patients were evaluated using Young Mania Rating Scale (YMRS) at baseline and weeks 2, 4, and 8. The primary outcome measure was to assess the efficacy of celecoxib compared with placebo in improving mania symptoms. RESULT: General linear model repeated measures showed significant effect for time × treatment interaction on YMRS scores [F (2.54, 96.56) = 3.21, p = 0.03]. Significantly greater improvement was observed in YMRS scores in the celecoxib group compared with the placebo group from baseline YMRS score at week 8 (p = 0.04). Although a 35% greater response to treatment (considering a Clinical Global Impressions-Improvement score of ≤2, very much/much improved) was observed in the celecoxib group compared with the placebo group, the difference did not reach the statistical significance level (p = 0.09). No serious adverse event was reported. CONCLUSIONS: Celecoxib may be an effective adjuvant therapy in treatment of manic episodes (without psychotic features) of adolescents with bipolar mood disorder. The mood-stabilizing role of this drug might be mediated through its action on inflammatory cascades.

Assessment of corrected flow time in carotid artery via point-of-care ultrasonography: Reference values and the influential factors.

OBJECTIVE: Assessment of Corrected Flow Time (FTc) in carotid artery has been suggested recently as a measure of intravascular volume status. This study aimed to determine the reference values of FTc in carotid artery in a normal population. METHODS: A total number of 142 healthy volunteers (73 females and 69 males) with a mean age of 36.65±10.52years were included. RESULTS: The mean FTc in carotid artery was 325.18±22.15ms0.5. The mean value of FTc differed significantly between females and males both before and after passive leg raise (PLR) (330.18±21.61ms0.5 vs. 319.88±21.62, P=0.005 before PLR, and 336.89±22.95ms0.5 vs. 326.51±21.21, P=0.006 after PLR). CONCLUSION: This study would potentially pave the way to determine clinically significant cutoff points in order to assess the diagnostic accuracy of FTc in predicting intravascular volume status and fluid therapy responsiveness.

Magnetic Resonance Enterography in 300 Known Cases of Crohn's Disease: An Initial Report from a Referral Center in Iran.

BACKGROUND Magnetic resonance enterography (MRE) has become the modality of choice in assessment of patients with Crohn's disease (CD). We aimed to present our experience on 300 patients with CD who underwent MRE during the first 30 months after setting up MRE for the first time in a referral center in Iran. METHODS Patients with a definite diagnosis of CD based on either ileocolonoscopy or histopathological studies were included in the final report and categorized into four phenotypes of inactive, active, stricturing, and penetrating disease. RESULTS This was a case series study on 300 patients with known CD out of 594 referred subjects. The most prevalent phenotype was inactive observed in 162 (54.0%) patients followed by stricturing in 44 (14.7%), active in 40 (13.3%), penetrating in 27(9%), and active on chronic in 27 (9%) cases. The number of referred patients increased from 51 cases in the first 6 months to 165 in the last 6 months. CONCLUSION This study presents the first report on the application of MRE in Iran as superb modality for management of CD. The growing number of referred patients indicates that MRE has been successful in addressing the most critical concerns of clinicians on determining the dominant disease phenotype.

Central Obesity and Liver Iron Content: A Noninvasive Assessment in General Population by Magnetic Resonance Imaging.

BACKGROUND/AIM: Existing evidence points to an altered status of iron metabolism in obesity. We aimed to investigate whether central obesity is independently associated with estimated liver iron content (liver T2* value) in general population that used the noninvasive assessment method by MRI. METHODS: The study was carried out on 200 subjects randomly selected from the Golestan Cohort Study who underwent abdominal MRI. Quantitative T2* maps of entire cross-sectional area of liver were calculated using a semi-automated software for estimating the levels of iron content. Segmentation and calculation of visceral (VFA) and subcutaneous fat area (SFA) were also performed. RESULTS: There was no significant difference in mean liver T2* values between obese (body mass index, BMI >30 kg/m2) and non-obese (BMI ≤30 kg/m2) subjects. After controlling for other covariates, no statistically significant association was detected between liver T2* values and VFA, SFA and VFA/SFA ratio. The drop in the relative signal intensity as an indicator of steatosis and serum ferritin predicted liver T2* values that almost had the same strength (standardized ß of -0.41 and -0.41, respectively). CONCLUSIONS: Central obesity indices are not correlated with estimated liver iron content by MRI. Hepatic steatosis and serum ferritin seem to be the best predictors of hepatic T2* value. Since central obesity indices were not direct predictors of hepatic T2* value after the adjustment for confounding factors, it is possible that lipid accumulation in the liver locally, but not systematically, influences hepatic iron metabolism.

Agomelatine as a Treatment for Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A Double-Blind, Randomized Clinical Trial.

OBJECTIVE: Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurodevelopmental disorder. Due to lack of response to the medication and significant side effects of the treatment with stimulants, alternative medications should be considered. The aim of this study is to evaluate efficacy of agomelatine in treatment of ADHD. METHODS: Fifty-four outpatients, children 6-15 years old, with diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria participated in a 6-week, parallel, double-blind, randomized clinical trial. Fifty patients completed 6 weeks of treatment with either ritalin (methylphenidate hydrochloride [MPH]) (20 mg/day in participants below 30 kg and 30 mg/day in patients with weight ≥30 kg) or agomelatine (15 mg/day in patients with weight ≥30 kg and 25 mg/day in patients with weight ≥45 kg). Participants were assessed using Parent and Teacher ADHD Rating Scale-IV at baseline and at weeks 3 and 6. RESULTS: General linear model repeated measures showed no significant differences between the two groups on Parent and Teacher Rating Scale scores (F = 1.13, df = 1.26, p = 0.305, and F = 0.95, df = 1.25, p = 0.353, respectively). Changes in Teacher and Parent ADHD Rating Scale scores from baseline to the study end were not significantly different between the agomelatine group (9.28 ± 8.72 and 24.12 ± 7.04, respectively) and the MPH group (6.64 ± 11.04 and 25.76 ± 7.82, respectively) (p = 0.46 and p = 0.44, respectively). There was a trend for less insomnia in the agomelatine group versus MPH-treated group (4% vs. 24%, p = 0.09). CONCLUSIONS: A treatment course of 6 weeks with agomelatine demonstrated a favorable safety and efficacy profile in children and adolescents with ADHD. Nonetheless, larger controlled studies with longer treatment periods are necessary.