Sertraline Treatment Research Articles

Exploring evidence of a dissociative subtype in PTSD: Baseline symptom structure, etiology, and treatment efficacy for those who dissociate.

With the inclusion of a dissociative subtype, recent changes to the DSM-5 diagnosis of posttraumatic stress disorder (PTSD) have emphasized the role of dissociation in the experience and treatment of the disorder. However, there is a lack of research exploring the clinical impact for highly dissociative groups receiving treatment for PTSD. The current study examined the presence and clinical impact of a dissociative subtype in a sample of individuals receiving treatment for chronic PTSD. This study used latent transition analyses (LTA), an expanded form of latent profile analyses (LPA), to examine latent profiles of PTSD and dissociation symptoms before and after treatment for individuals (N = 200) receiving prolonged exposure (PE) or sertraline treatment for chronic PTSD. The best fitting LTA model was one with a 4-class solution at both pretreatment and posttreatment. There was a latent class at pretreatment with higher levels of dissociative symptoms. However, this class was also marked by higher reexperiencing symptoms, and membership was not predicted by chronic child abuse. Further, although those in the class were less likely to transition to the responder class overall, this was not the case for exposure-based treatment specifically. These findings are not in line with the dissociative-subtype theoretical literature that proposes those who dissociate represent a clinically distinct group that may respond worse to exposure-based treatments for PTSD. (PsycINFO Database Record

Brain serotonin synthesis capacity in obsessive-compulsive disorder: effects of cognitive behavioral therapy and sertraline

Cognitive behavioral therapy (CBT) and selective serotonin reuptake inhibitors (SSRIs) are both effective treatments for some patients with obsessive-compulsive disorder (OCD), yet little is known about the neurochemical changes related to these treatment modalities. Here, we used positron emission tomography and the α-[11C]methyl-l-tryptophan tracer to examine the changes in brain regional serotonin synthesis capacity in OCD patients following treatment with CBT or SSRI treatment. Sixteen medication-free OCD patients were randomly assigned to 12 weeks of either CBT or sertraline treatment. Pre-to-post treatment changes in the α-[11C]methyl-l-tryptophan brain trapping constant, K* (ml/g/min), were assessed as a function of symptom response, and correlations with symptom improvement were examined. Responders/partial responders to treatment did not show significant changes in relative regional tracer uptake; rather, in responders/partial responders, 12 weeks of treatment led to serotonin synthesis capacity increases that were brain-wide. Irrespective of treatment modality, baseline serotonin synthesis capacity in the raphe nuclei correlated positively with clinical improvement. These observations suggest that, for some patients, successful remediation of OCD symptoms might be associated with greater serotonergic tone.

T146. Anxiety-Potentiated Startle Reductions Correlate With Symptom Reduction by Sertraline in Premenstrual Dysphoric Disorder (PMDD)

Premenstrual dysphoric disorder (PMDD) affects millions of women worldwide, and is thought to reflect suboptimal sensitivity to the GABAergic progesterone metabolite allopregnanolone (ALLO). Anxiety-potentiated startle (APS), evoked by unpredictable threat, is mediated by the ALLO-sensitive bed nucleus of the stria terminalis (BNST), and is used in this study as a marker of GABAergic sensitivity. We hypothesized that luteal (L) phase sertraline treatment will reduce premenstrual mood symptoms, and the magnitude of symptom reduction will correlate with magnitude of APS reduction. We hypothesized that fear-potentiated startle (FPS) to predictable threat, which is not mediated by BNST, will not correspond to symptom reduction.

Elevated stress hormone levels and antidepressant treatment starting before pregnancy affect maternal care and litter characteristics in an animal model of depression

Many women who take antidepressant medications become pregnant while taking their medication; however, the impact of depression and antidepressant medication on fetal development is not well understood. This study used a translational animal model of maternal depression to investigate the consequences of discontinuing antidepressant medication during pregnancy. First, rats received corticosterone (CORT; 40 mg/kg, s.c.) or vehicle to induce a depressive-like phenotype. After 16 days of treatment with CORT or vehicle, animals were treated with sertraline (a selective serotonin reuptake inhibitor, SSRI; 20 mg/kg) or vehicle via gavage. Following 21 days of CORT or oil treatment, rats were mated. One group receiving sertraline was discontinued from treatment on gestational day 16, and another group continued sertraline treatment throughout pregnancy to assess the effects of discontinuation. After weaning, dams were sacrificed via perfusion to investigate neurogenesis. As intended, CORT administration created a depressive-like phenotype with increased immobility in the Forced Swim Test and reduced body weight. Interestingly, sertraline treatment could not rescue these altered features. Pre-conceptional CORT exposure resulted in smaller litters and CORT dams that received sertraline until the end of gestation spent more time off of the nest compared to CORT dams that received vehicle or discontinued sertraline during gestation. There was no difference in hippocampal neurogenesis between any of the groups. Our results suggest that treatment with antidepressants may have different effects in healthy or depressed dams, however, we need more research to investigate the detailed and long-term effects of maternal depression and its treatment in translational animal models.

Psychogenic polydipsia associated with sertraline treatment: a case report

ABSTRACTPsychogenic polydipsia (PP) is a clinical condition characterized by excessive fluid intake in the absence of physiological stimuli to drink. The etiology of compulsive water drinking is not known yet. It is common in people with chronic mental illness, especially in schizophrenia. Obsessive-compulsive disorder (OCD) is characterized by the presence of recurrent obsessions and compulsions which may cause anxiety in the person. The age of onset is bimodal, before puberty and early adulthood. In this case report, we will discuss the PP situation after the start of sertraline treatment in a case of 12-year-old girl who started sertraline treatment with the diagnosis of OCD.

Efficacy of sertraline and gabapentin in the treatment of urethral pain syndrome: retrospective results of a single institutional cohort.

IntroductionUrethral pain syndrome is a subgroup of chronic pelvic pain syndromes and comprises a relatively challenging patient group in urological practice. Several different treatments have been used for the management of the condition from a mostly empirical basis. In this article, we present the results of a small cohort of young male patients treated with sertraline and gabapentin therapy.Material and methodsThe data of 52 patients was retrospectively evaluated and 31 patients' data was included in this study. Clinical symptom scores, including International Prostate Symptoms Score, Hamilton Anxiety Rating Scale, Visual Analog Scale for Pain, Quality of Life due to Lower Urinary Tract Symptoms, and Urinary, Psychosocial, Organ Specific, Infection, Neurologic/Systemic, Tenderness of Skeletal Muscles (UPOINT) classifications were retrospectively analyzed from the patient records and charts.ResultsWe observed improvement in clinical scores involving anxiety, lower urinary tract symptoms, quality of life, and pain. Statistical analysis revealed significant amelioration of the symptoms with gaba- pentin and sertraline treatment in our cohort.ConclusionsGabapentin and sertraline treatment may be considered in the second step management of urethral pain syndrome. To draw an evidence-based recommendation, prospective and comparative studies should be conducted in the future.

Presence of neuroticism and antidepressant remission rates in late-life depression: results from the Neurobiology of Late-Life Depression (NBOLD) study.

ABSTRACTNeuroticism in older adults is common yet understudied, particularly its effects on depression treatment outcomes. We hypothesized that presence of high neuroticism would be associated with lower 12-week remission rates in older depressed sertraline-treated patients. In this longitudinal cohort study, 43 depressed older adults completed the Revised NEO Personality Inventory (NEO PI-R). A study psychiatrist administered the Montgomery Ǻsberg Depression Rating Scale (MADRS), and the Cumulative Illness Rating Scale (CIRS, a measure of medical burden) at baseline, and the MADRS at each clinical visit. All subjects began open-label sertraline treatment and were followed over 12 weeks with clinically indicated flexible dosing and an option to switch antidepressants. We used regression analyses to examine factors related to 12-week remission of depression (MADRS score < 8) and final MADRS score. We found that higher total neuroticism (odds ratio (OR) = 0.963, 95% confidence interval (CI) = 0.928-1.000) and a neuroticism subscale, stress vulnerability (OR = 0.846, 95% CI = 0.728-0.983), were associated with lower likelihood of remission among both the intention-to-treat group and sertraline completers. Findings remained significant after controlling for baseline MADRS and CIRS score. In conclusion, assessment of personality, particularly features of neuroticism, may be important in management of late-life depression. Future studies should determine if depressed patients high in neuroticism may benefit from psychotherapy focusing on emotional regulation and stress management.

Relationships of depressive behavior and sertraline treatment with walking speed and activity in older female nonhuman primates.

Depression is the most common mental health problem in aging persons and is a leading risk factor for physical disability, especially in women. Though antidepressant drugs such as serotonin reuptake inhibitors (SSRI) are commonly prescribed, epidemiological evidence reveals mixed effects of long-term antidepressant use on physical function and activity, possibly depending on depressive status. The purpose of this preclinical trial was to determine the relationships of depressive behavior and the potential for an SSRI treatment to modulate walking speed and activity patterns in older adult female cynomolgus monkeys (Macaca fascicularis). We evaluated the effects of depression and a commonly prescribed SSRI, sertraline HCl (20mg/kg/day p.o.), on (a) walking speed, (b) accelerometry-derived activity (counts) and sedentariness (daytime 60-s sedentary epochs), and (c) observed locomotor and sedentary behaviors (% time) in adult female depressed and nondepressed monkeys (n=42; 17.2±1.8years) during an 18month pre-treatment phase and an 18month treatment phase using a longitudinal, stratified placebo-control study design. Monkeys that were depressed prior to treatment (19/42) subsequently had slower walking speeds (F D [1, 38] =4.14; p≤0.05) and tended to be more sedentary during the daytime (F D [1, 38] =3.63; p≤0.06). Sertraline did not affect depressive behaviors, walking speed, accelerometry-derived physical activity or sedentariness, or time observed in total locomotor or sedentary behavior (all p>0.10). This study provides the first experimental demonstration of relationships between nonhuman primate behavioral depression and walking speed, activity, and sedentariness and provides evidence for a lack of an effect of SSRI treatment on these phenotypes.

Severe liver toxicity in a chronic myeloid leukemia patient probably induced by a drug interaction between imatinib and sertraline.

Our objective is to describe a chronic myeloid leukemia patient with a severe liver toxicity likely due to a drug-drug interaction between imatinib and sertraline. The patient started treatment with sertraline three months after starting imatinib. From the beginning of sertraline treatment, the patient developed vomiting, and five weeks later she developed a severe hepatic failure and was admitted to the hospital. The Naranjo nomogram showed a probable correlation between this adverse effect and the interaction between imatinib and sertraline. This interaction is extremely rare and the mechanism of action is not clear; it could be a mix of pharmacokinetic and pharmacodynamic processes. To our knowledge, this is the first case in medical literature of a severe liver toxicity due to an interaction between imatinib and sertraline. This interaction is also not described in the main secondary data sources, such as Lexicomp® and Micromedex®. However, due to the severity of this event, the hepatic function should be carefully monitored in patients treated with imatinib and sertraline.

Correction to: Comparative effects of sertraline, haloperidol or olanzapine treatments on ketamine-induced changes in mouse behaviours.

In the original publication of the article, occurrences of "{F(Becker and Grecksch 2004; Onaolapo et al. 2016b)" should have been "{F(5, 54)" throughout the article.

Long-term sertraline treatment and depression effects on carotid artery atherosclerosis in premenopausal female primates.

Atherosclerosis developed during premenopausal years predicts postmenopausal atherosclerosis burden. Selective serotonin reuptake inhibitor (SSRI) antidepressants, recently approved for hot flushes, have been associated with increased ischemic stroke risk in several observational studies; however, effects on carotid artery atherosclerosis, a strong predictor of future vascular events, are unknown. The effects of chronic administration of a commonly prescribed SSRI, sertraline HCl, on atherosclerosis in the carotid artery was assessed in a placebo-controlled, longitudinal, randomized study of premeonopausal depressed and nondepressed cynomolgus monkeys (Macaca fascicularis; n = 42). Physiologic and behavioral phenotypes were evaluated at baseline and after 18 months of oral sertraline (20 mg/kg, n = 21) or placebo (n = 21). Carotid artery atherosclerosis was measured post mortem via histomorphometry. Atherosclerosis extent in the right common carotid artery, on average, was 60% greater in sertraline-treated depressed monkeys compared with all other groups (P = 0.028). The results of linear regression analyses suggested that sertraline and depression effects on atherosclerosis were not mediated by their effects on behavioral and physiological risk factors. These findings suggest that chronic SSRI treatment is associated with the progression of carotid artery atherosclerosis, which may increase the risk for future vascular events, particularly in depressed women. The underlying mechanism remains to be determined, but does not appear to be related to SSRI effects on traditional cardiovascular risk factors.

Identification of translationally controlled tumor protein in promotion of DNA homologous recombination repair in cancer cells by affinity proteomics

Translationally controlled tumor protein(TCTP) has been implicated in the regulation of apoptosis, DNA repair and drug resistance. However, the underlying molecular mechanisms are poorly defined. To better understand the molecular mechanisms underlying TCTP involved in cellular processes, we performed an affinity purification-based proteomic profiling to identify proteins interacting with TCTP in human cervical cancer HeLa cells. We found that a group of proteins involved in DNA repair are enriched in the potential TCTP interactome. Silencing TCTP by short hairpin RNA in breast carcinoma MCF-7 cells leads to the declined repair efficiency for DNA double-strand breaks on the GFP-Pem1 reporter gene by homologous recombination, the persistent activation and the prolonged retention of γH2AX and Rad51 foci following ionizing radiation. Reciprocal immunoprecipitations indicated that TCTP forms complexes with Rad51 in vivo, and the stability maintenance of Rad51 requires TCTP in MCF-7 cells under normal cell culture conditions. Moreover, inactivation of TCTP by sertraline treatment enhances UVC irradiation-induced apoptosis in MCF-7 cells, and causes sensitization to DNA-damaging drug etoposide and DNA repair inhibitor olaparib. Thus, we have identified an important role of TCTP in promoting DNA double-stand break repair via facilitating DNA homologous recombination processes and highlighted the great potential of TCTP as a drug target to enhance conventional chemotherapy for cancer patients with high levels of TCTP expression.

Detecting Serotonin System in Rats with Myocardial Infarction and/or Depression after Selective Serotonin Reuptake Inhibitor Therapy

Objectives: The aim of this study is to explore the effects on serotonergic system of sertraline in the Sprague–Dawley (SD) rats of myocardial infarction (MI), depression, and depression post-MI. Methods: A total of 80 SD rats were randomly allocated into two pretreatment groups, including saline-pretreated group and sertraline-pretreated group. The sertraline-pretreated rats received sertraline and the saline-pretreated rats received saline for the past 4 weeks. Then, the two groups were randomly divided into four subgroups, respectively, including sham, MI, depression, and depression post-MI (MI + depression) subgroup. All animals were then sacrificed after 3 days to observe the effects of sertraline on levels of 5-HT, 5-HT2AR, and SERT in the rat serum, platelet, and brain. Results: As compared with saline treatment group, serum 5-HT decreased significantly in sham subgroup and increase significantly in MI, depression, and MI-depression subgroups, platelet 5-HT increased significantly, brain 5-HT decreased significantly in the four subgroups after sertraline treatment (all P &lt; 0.05). As compared with saline treatment group, platelet 5-HT2AR decreased significantly in the sham subgroup and increased significantly in MI and depression subgroups, brain 5-HT2AR increased significantly in MI subgroup and decreased significantly in depression and MI + depression subgroups after sertraline treatment (all P &lt; 0.05). As compared with saline treatment group, serum SERT decreased significantly in the sham subgroup and increased significantly in depression subgroup, platelet SERT decreased significantly in the four subgroups and brain SERT increased significantly in sham and depression subgroups and decrease significantly in MI subgroup after sertraline treatment (all P &lt; 0.05). Conclusion: Sertraline regulated 5-HT concentration of peripheral blood and brain according to 5-HT2AR and SERT, thereby regulating the platelet function in various pathological states including MI, depression, and depression post-MI.

Molecular biomarkers predictive of sertraline treatment response in young children with fragile X syndrome

ObjectivesSeveral neurotransmitters involved in brain development are altered in fragile X syndrome (FXS), the most common monogenic cause of autism spectrum disorder (ASD). Serotonin plays a vital role in synaptogenesis and postnatal brain development. Deficits in serotonin synthesis and abnormal neurogenesis were shown in young children with autism, suggesting that treating within the first years of life with a selective serotonin reuptake inhibitor might be the most effective time. In this study we aimed to identify molecular biomarkers involved in the serotonergic pathway that could predict the response to sertraline treatment in young children with FXS. MethodsGenotypes were determined for several genes involved in serotonergic pathway in 51 children with FXS, ages 24–72months. Correlations between genotypes and deviations from baseline in primary and secondary outcome measures were modeled using linear regression models. ResultsA significant association was observed between a BDNF polymorphism and improvements for several clinical measures, including the Clinical Global Impression scale (P=0.008) and the cognitive T score (P=0.017) in those treated with sertraline compared to those in the placebo group. Additionally, polymorphisms in the MAOA, Cytochrome P450 2C19 and 2D6, and in the 5-HTTLPR gene showed a significant correlation with some of the secondary measures included in this study. ConclusionThis study shows that polymorphisms of genes involved in the serotonergic pathway could play a potential role in predicting response to sertraline treatment in young children with FXS. Larger studies are warranted to confirm these initial findings.

Beta Adrenoceptor Polymorphism and Clinical Response to Sertraline in Major Depressive Patients.

The adrenoceptor family, as one of the main contributors in regulating the noradrenergic system, has been studied in involvement of depression and its treatment. A functional polymorphism of G1165C on beta adrenoceptor (βAR) enhances post receptor signalling and is assumed to be involved in pharmacotherapy of depression. The aim of the present study was to discern the influence of G1165C polymorphism in the β1AR gene on individual differences in response to sertraline. One hundred newly diagnosed patients completed 6 weeks of sertraline treatment. Response to treatment was defined as a 50% decrease in Hamilton Rating Scale for depression (HRSD). The patients who carried CC genotype responded five times more to sertraline comparing with other variants (P=0.005; OR=5.7; 95%CI=1.4-23.9). Moreover, carriers of C allele responded three times more to sertraline than patients with the G allele (P=0.001; OR= 3.3; 95%CI= 1.72-6.50). In conclusion, our results support the hypothesis that genetic variation of β1AR might influence clinical response to sertraline.This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

Oromandibular dystonia with sertraline treatment: a case report

Selective serotonin reuptake inhibitors are generally first choice drugs in the treatment of depression, anxiety disorder, eating disorder and various psychiatric disturbances, such as impulse control disorder. Sertraline is a selective serotonin reuptake inhibitor. It also makes dopamine reuptake inhibition. It may show somnolence, nervousness, sweating, drowsiness, insomnia, dizziness, nausea, chilling, skin rash, dyspepsia, loss of appetite, headache, diarrhea, ejaculation disorder, dry mouth, and weight loss as side effects. It has been reported that akathisia, dystonia, tardive dyskinesia and Parkinsonism may be seen as the extrapyramidal system findings during use of sertraline. Acute dystonia is a psychiatric emergency. It develops not only due to use of antipsychotics but, it has also been reported to occur due to use of antiemetics and antidepressants as well. In this report, we present a case with oromandibular dystonia, which developed during 50 mg sertraline treatment on the patient with adjustment disorder. Clinicians should always keep in their mind that there may be extrapyramidal side effects during use of selective serotonin reuptake inhibitors.

Sertraline Induces Toxicity and Behavioral Alterations in Planarians.

Toxicity attributed to sertraline has been demonstrated recently in different cell types and also in some organisms. We investigated the effect of sertraline on planarians, which are considered suitable for investigations in neurotoxicology and currently are widely used as an animal model in neuropharmacological studies. Planarians treated with 10 µM sertraline showed a rapid reduction in their spontaneous movement until they became completely motionless and then showed a series of asynchronous paroxysms (seizures) followed by progressive tissue damage, beginning 48 h after the sertraline treatment, and died approximately 72 h later. Our data showed that sertraline does not cause planarian death within the range of therapeutic concentrations; however, behavioral alterations were observed with concentrations that can be considered compatible with therapeutic ones, such as a significant reduction in planarian locomotory activity at 0.4 µM. Treatment with 4 µM sertraline had a significant effect, reducing planarian locomotory activity and increasing the number of asynchronous paroxysms; both effects were significantly maintained even 24 h after the sertraline was withdrawn. These behavioral changes observed at low micromolar concentrations suggest that sertraline might have residual biological consequences for planarians, even after it is withdrawn.

Hair Loss Associated with Sertraline: Two Case Reports and Review

Introduction: Selective serotonin reuptake inhibitors (SSRIs) are widely advised as antidepressants. Association of SSRIs with hair loss is rare and limited to a few case reports. In this case study, two patients developed diffuse hair loss during sertraline treatment. Case Presentation: Mr. A was a 47-year-old married man with a diagnosis of panic disorder according to the DSM-V criteria and specific phobia (claustrophobia). Approximately 8 weeks after starting sertraline intake, he noticed hair loss. Decreasing the dose of his medication led to the resolution of hair loss within 6 weeks. Ms. M was a woman with major depressive disorder who complained of hair loss during treatment with sertraline within only 2 months of treatment (at the beginning of treatment) while she was receiving a low dose of sertraline (unlike the other case). Conclusions: SSRIs-induced hair loss is an infrequently observed adverse effect that may be overlooked. These case reports reinforce the need for maintaining a high index of suspicion regarding any incident of sudden hair loss occurring in persons taking even low doses of SSRIs like sertraline. Hair loss should also be questioned during the control sessions in addition to other side effects as it may influence patient’s outer appearance and negatively affect his/her adherence to treatment.

Sertraline for Preventing Mood Disorders Following Traumatic Brain Injury: A Randomized Clinical Trial.

Prevention is more effective than treatment to decrease the burden of significant medical conditions such as depressive disorders, a major cause of disability worldwide. Traumatic brain injury (TBI) is a candidate for selective strategies to prevent depression given the incidence, prevalence, and functional effect of depression that occurs after TBI. To assess the efficacy of sertraline treatment in preventing depressive disorders following TBI. A double-blind, placebo-controlled, parallel-group randomized clinical trial was conducted at a university hospital from July 3, 2008, to September 17, 2012, with 24 weeks of follow-up. A consecutive sample of 534 patients aged 18 to 85 years, hospitalized for mild, moderate, or severe TBI, was eligible for the study. Ninety-four patients consented to participate and were randomized (46 to placebo and 48 to sertraline), of whom 79 (84%) completed the study. Intention-to-treat data analysis was conducted from July 1, 2014, to December 31, 2015. Placebo or sertraline, 100 mg/d, for 24 weeks or until development of a mood disorder. Time to onset of depressive disorders, as defined by the DSM-IV, associated with TBI. Of the 94 patients in the study (38 female and 56 male; 92 white), the number needed to treat to prevent depression after TBI at 24 weeks was 5.9 (95% CI, 3.1-71.1; χ2 = 4.6; P = .03) for sertraline treatment vs placebo. The influence of sertraline in the course of neuropsychological variables was not detected. The intervention was well tolerated, and adverse effects were mild in both the sertraline and placebo groups. Sertraline appears to be efficacious to prevent the onset of depressive disorders following TBI. Future studies should replicate these findings in a large sample of patients with TBI and depict their long-term physical, cognitive, behavioral, and functional outcomes. clinicaltrials.gov Identifier: NCT00704379.

A Randomized, Double-Blind, Placebo-Controlled Trial of Low-Dose Sertraline in Young Children With Fragile X Syndrome.

Observational studies and anecdotal reports suggest that sertraline, a selective serotonin reuptake inhibitor, may improve language development in young children with fragile X syndrome (FXS). The authors evaluated the efficacy of 6 months of treatment with low-dose sertraline in a randomized, double-blind, placebo-controlled trial in 52 children with FXS aged 2 to 6 years. Eighty-one subjects were screened for eligibility, and 57 were randomized to sertraline (27) or placebo (30). Two subjects from the sertraline arm and 3 from the placebo arm discontinued. Intent-to-treat analysis showed no difference from placebo on the primary outcomes: the Mullen Scales of Early Learning (MSEL) expressive language (EL) age equivalent and Clinical Global Impression Scale-Improvement. However, analyses of secondary measures showed significant improvements, particularly in motor and visual perceptual abilities and social participation. Sertraline was well tolerated, with no difference in side effects between sertraline and placebo groups. No serious adverse events occurred. This randomized controlled trial of 6 months of sertraline treatment showed no primary benefit with respect to early EL development and global clinical improvement. However, in secondary exploratory analyses, there were significant improvements seen on motor and visual perceptual subtests, the cognitive T score sum on the MSEL, and on one measure of social participation on the Sensory Processing Measure-Preschool. Furthermore, post hoc analysis found significant improvement in early EL development as measured by the MSEL among children with autism spectrum disorder on sertraline. Treatment appears safe for this 6-month period in young children with FXS, but the authors do not know the long-term side effects of this treatment. These results warrant further studies of sertraline in young children with FXS using refined outcome measures as well as longer term follow-up studies to address long-term side effects of low-dose sertraline in early childhood.