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Insufficient data inform dosing of antidepressants and clinical monitoring for major depressive disorder (MDD) during the perinatal period. The objectives were to assess the pharmacokinetics of sertraline (SER) across pregnancy and postpartum. Participants treated with SER for MDD underwent serial sampling to measure steady-state concentrations of SER and norsertraline during the second and third trimesters and postpartum (total of 3 assessments). Blood was drawn before observed SER administration and 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration. A sensitive high-performance liquid chromatography/mass spectrometric method for simultaneous determination of serum concentrations of SER and norsertraline was developed and validated. For each sampling period for SER, area under the serum concentration versus time curve, maximal serum concentration (Cmax), and the time at which Cmax occurred (Tmax) were determined. Of 11 women initially enrolled, 6 completed second- and third-trimester assessments, and 3 completed all 3 assessments (including the postpartum assessment). Mean changes on all pharmacokinetic parameters were nonsignificant between assessments, although there was a marked heterogeneity among individuals. Results were not significantly altered by incorporation of body weights into the analyses. The range of pharmacokinetic changes between individuals was broad, indicating heterogeneity regarding the impact of pregnancy on SER metabolism. Overall, lowest observed SER area under the curve and Cmax occurred in the third trimester (observed in 5 of 6 participants). Despite nonsignificant mean pharmacokinetic changes, the range of pharmacokinetic changes across pregnancy warrants careful monitoring of depressive symptoms in women with MDD in late pregnancy and further study.
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This study described a microdosing method that combined PET with LC-MS/MS for determining the brain distribution and PK characteristics of a CNS drug candidate.
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Only randomized, placebo-controlled trials and meta-analyses that compared an antidepressant with placebo for the treatment of depression in patients with dementia were included.
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Children with asthma frequently have significant anxiety and depression that interfere with treatment outcome. Although the use of antidepressants may be helpful, in the one published study of antidepressant use in pediatric asthma, significant side effects necessitated discontinuance; these side effects were increased motor activity, impulsive behavior, insomnia, postural hypotension, premature auricular contractions, diastolic hypertension, and generalized seizure. The objective of this retrospective chart review was to examine whether antidepressants could be tolerated and administered safely to children on asthma medications. Forty pediatric inpatients (mean age 13.3 years, range 7-19) with varying levels of asthma severity (5 mild, 11 moderate, 24 severe) and an average duration of asthma treatment of 10.0 years were administered antidepressants while also taking an average of 5 medications for asthma (range 2-7). Ten of the patients had an additional comorbid medical diagnosis. There were 17 children diagnosed with a primary affective disorder; 7 with a primary anxiety disorder; and 16 with both an affective and anxiety disorder. Thirty-six children ultimately were continued on an antidepressant: 13 on desipramine, 9 on nortriptyline, 6 on imipramine, 4 on fluoxetine, 3 on bupropion, and 1 on sertraline. Significant cardiovascular side effects (tachycardia, hypertension, and postural hypotension) occurred in 4 subjects on tricyclic antidepressants (TCAs) and 1 subject on a non-TCA (fluoxetine); 3 of these subjects were able to continue treatment with an antidepressant. Two subjects were taken off antidepressants because of hypomanic symptoms (increased motor activity, mood lability, impulsive behavior, and insomnia). No medications were discontinued because of electrocardiogram changes, arrhythmias, or seizures. Doses of TCAs were comparable to those in previous studies, but the asthma medications differed. Discussion of current anti-asthmatic medications and potential for interactions with antidepressants is included.
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Patients of any age or gender, with chronic or recent onset PTSD arising from any type of event relevant to the diagnostic criteria were included. A combination of any psychological therapy and pharmacotherapy was included and compared to wait list, placebo, standard treatment or either intervention alone. The primary outcome was change in total PTSD symptom severity. Other outcomes included changes in functioning, depression and anxiety symptoms, suicide attempts, substance use, withdrawal and cost.
In part 2, we discuss the rationale for treatment of PSD, appraise the evidence for effectiveness of the different antidepressant drugs, and consider whether we can identify a recommended first-line treatment for use in our ICP.
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Venlafaxine is a commonly prescribed antidepressant, but whether its noradrenergic effects impart increased cardiovascular risk is unknown. We sought to examine the cardiac safety of venlafaxine relative to sertraline in older patients.
Despite cognitive function impairment in depression, its relationship to treatment outcome is not well understood. Here, we examined whether pretreatment activation of cortical circuitry during test of cognitive functions predicts outcomes for three commonly used antidepressants.
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There was no significant difference in rate of switching between the different classes of antidepressant (p = .1) nor between drugs within the SSRI class (p = .513). When medication change was the independent factor, significant differences between the groups were total time in treatment and number of visits (p < .001 and p = .011, respectively). Age, education, and Clinical Global Impressions-Severity of Illness scale scores (admission, discharge, and change) were not significantly different between the groups.
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Antidepressant medications have appeared to be effective treatments for premenstrual syndrome (PMS) in several small trials. This open-label study examined the efficacy of and tolerance for a new serotonergic antidepressant compared with a traditional tricyclic antidepressant in PMS treatment.
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The study recruited patients admitted to inpatient care for acute heart failure exacerbations, after psychiatric diagnostic interview. Patients with Beck Depression Inventory (BDI) scores lower than 10 and with no history of depression served as the nondepressed reference group (n = 25). MDD severity was defined as follows: mild (BDI 10-15; n = 48), moderate (BDI 16-23; n = 51), and severe (BDI ≥ 24; n = 33). A Bio-Plex assay measured 18 inflammation markers. Ordinal logistic models were used to examine the association of MDD severity and biomarker levels.
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Agomelatine did not seem to provide a significant advantage in efficacy over other antidepressive agents for the acute-phase treatment of major depression. Agomelatine was better tolerated than paroxetine and venlafaxine in terms of overall side effects, and fewer participants treated with agomelatine dropped out of the trials due to side effects compared to sertraline and venlafaxine, but data were limited because the number of included studies was small. We found evidence that compared agomelatine with only a small number of other active antidepressive agents, and there were only a few trials for each comparison, which limits the generalisability of the results. Moreover, the overall methodological quality of the studies was low, and, therefore, no firm conclusions can be drawn concerning the efficacy and tolerability of agomelatine.
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Seventy-three percent of the patients responded to the given treatment. The relapse rates were 12.5% in the c-pharm early group, 28% in the c-pharm late group, and 67% in the placebo group (P = 0.09). The c-pharm early strategy resulted in significantly lower relapse rates and longer well time compared with the placebo (P = 0.04). When the trend with the initiation of the c-pharm intervention was investigated in the 3 groups with equally spaced trend weights, the time of initiation was found to have a significant effect on the probability of the remaining well (P = 0.03).
Survival analysis methods such as the Kaplan-Meier method, log-rank test, and Cox proportional hazards regression (Cox regression) are commonly used to analyze data from randomized withdrawal studies in patients with major depressive disorder. However, unfortunately, such common methods may be inappropriate when a long-term censored relapse-free time appears in data as the methods assume that if complete follow-up were possible for all individuals, each would eventually experience the event of interest.
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Aquatic organisms can be affected not only via polluted water but also via their food. In the present study, we examined bioaccumulation of seventy pharmaceuticals in two benthic organisms, Hydropsyche sp. and Erpobdella octoculata in a small stream affected by the effluent from a sewage treatment plant (STP) in Prachatice (South Bohemia region, Czech Republic). Furthermore, water samples from similar locations were analyzed for all seventy pharmaceuticals. In water samples from a control locality situated upstream of the STP, ten of the seventy pharmaceuticals were found with average total concentrations of 200 ng L(-1). In water samples collected at STP-affected sites (downstream the STP's effluent), twenty-nine, twenty-seven and twenty-nine pharmaceuticals were determined at average total concentrations of 2000, 2100 and 1700 ng L(-1), respectively. Six of the seventy pharmaceuticals (azithromycin, citalopram, clarithromycin, clotrimazole, sertraline, and verapamil) were found in Hydropsyche. Four pharmaceuticals (clotrimazole, diclofenac, sertraline, and valsartan) were detected in Erpobdella. Using evaluation criterion bioconcentration factor (BCF) is higher than 2000 we can assign azithromycin and sertraline as bioaccumulative pharmaceuticals. Even pharmaceuticals present at low levels in water were found in benthic organisms at relatively high concentrations (up to 85 ng g(-1) w.w. for azithromycin). Consequently, the uptake of pharmaceuticals via the food web could be an important exposure pathway for the wild fish population.
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Using expressed sequence tag (EST) analysis, we previously identified certain molecular machinery that mediates antidepressant effects. To date, several partial cDNA fragments, termed antidepressant-related genes (ADRGs), have been isolated as ESTs from rat brain. In the present study, we identified two of the ADRGs to be rat neuroserpin. Using real-time quantitative PCR, we demonstrated increased neuroserpin mRNA expression in rat frontal cortex after chronic treatment with several classes of antidepressants, including imipramine, fluoxetine, sertraline, and venlafaxine. Electroconvulsive treatment (ECT), another therapeutic treatment for depression, also increased neuroserpin expression in rat frontal cortex. Neuroserpin is a serine protease inhibitor that is implicated in the regulation of synaptic plasticity, neuronal migration, and axogenesis in the central nervous system. In conclusion, our results support the hypothesis that neuroserpin-mediated plastic changes in frontal cortex may underlie the therapeutic action of antidepressants and ECT.
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DIO1 plays a key-role in T4 to T3 conversion and in clearance of the inactive metabolite, rT3. Previous data associate the DIO1-785T allele with lower DIO1 activity. This is consistent with our observation that responders to T3 supplementation had lower baseline serum T3 levels than non-responders. Depressed patients, who have a genetically determined lower T4 to T3 conversion, may be more likely to benefit from T3 supplementation.
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Three-hundred and thirty consecutive patients seeking treatment for their blushing were assessed by psychiatric interview and patient-rated scales. The Brief Social Phobia Scale was the primary outcome measure. Patients meeting Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition criteria for generalized social anxiety disorder, scoring 20 points or more in the Brief Social Phobia Scale and 19 points or more in the Social Phobia Inventory were considered eligible and followed up for a mean of 11 months (range 1-64) after endoscopic thoracic sympathectomy or initiation of sertraline.
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The possibility of recovery of behavioral deficits was examined in the present study. Rats were administered an MDMA pretreatment regimen that was shown to produce numerous serotonergic deficits and behavioral suppression 2 weeks thereafter. The full expression of MDMA-produced hyperactivity was dependent upon serotonergic integrity, therefore, the present study aimed to determine whether MDMA pretreated rats were tolerant to MDMA 2 weeks after exposure. Further, because serotonergic deficits have shown recovery over time, similar behavioral tests were conducted at a later time point to determine whether functional recovery was evident.
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All three SSRIs produced significant increases in reinforcement rate, but only sertraline and fluoxetine significantly decreased response rate. Additionally, paroxetine was observed to disrupt the pattern of responding as indicated by decreases in peak area (PkA). Sertraline and paroxetine, but not fluoxetine, produced increases in peak location (PkL).
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Participants were 488 youth (ages 7-17 years; 50% male) randomized to cognitive-behavioral therapy (CBT; Coping Cat), pharmacotherapy (sertraline), their combination, or placebo pill. Participants met criteria for generalized anxiety disorder, social phobia, and/or separation anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994). The therapeutic relationship was assessed by youth report at Weeks 6 and 12 of treatment using the Child's Perception of Therapeutic Relationship scale (Kendall et al., 1997). Outcome measures (Pediatric Anxiety Rating Scale; Research Units on Pediatric Psychopharmacology Anxiety Study Group, 2002; and Clinical Global Impressions Scales; Guy, 1976) were completed by independent evaluators blind to condition.
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Huntington's disease (HD) is an inherited progressive neurodegenerative disorder resulting from CAG repeat expansion in the gene that encodes for the protein huntingtin. To identify neuroprotective compound (s) that can slow down disease progression and can be administered long term with few side effects in Huntington's disease, we investigated the effect of sertraline, a selective serotonin reuptake inhibitor (SSRI) which has been shown to upregulate BDNF levels in rodent brains. We report here that in HD mice sertraline increased BDNF levels, preserved chaperone protein HSP70 and Bcl-2 levels in brains, attenuated the progression of brain atrophy and behavioral abnormalities and thereby increased survival. Sertraline also enhanced neurogenesis, which appeared to be responsible for mediating the beneficial effects of sertraline in HD mice. Additionally, the effective levels of sertraline are comparable to the safe levels achievable in humans. The findings suggest that sertraline is a potential candidate for treatment of HD patients.
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This study investigated the effectiveness of ketamine, a noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist, in alleviating the enhanced anxiety and fear response in both a mouse model of PTSD induced by inescapable electric foot shocks and a rat model of PTSD induced by a time-dependent sensitization (TDS) procedure. First, we evaluated the effect of ketamine on behavioral deficits in a mouse model of PTSD that consisted of foot shocks followed by three situational reminders. Our results showed that the aversive procedure induced several behavioral deficiencies, such as increased freezing behavior and anxiety, as well as reduced time spent in an aversive-like context, which were reversed by repeated treatment with ketamine. The effect of ketamine on behavioral changes after exposure to TDS was also investigated, and the levels of brain-derived neurotrophic factor (BDNF) in the hippocampus were measured. The results revealed that after TDS, the rats showed a significant increase in contextual freezing and a decrease in the percentage of time spent in and numbers of entries into open arms in the elevated plus maze test. As a positive control drug, sertraline (Ser, 15 mg/kg, i.g.), a selective serotonin reuptake inhibitor (SSRI) ameliorated these behavioral deficits. These behavioral effects were mimicked by chronic ketamine treatment. Furthermore, ketamine normalized the decreased BDNF level in the hippocampus in post-TDS rats. Taken together, these results suggest that ketamine exerts a therapeutic effect on PTSD that might be at least partially mediated by an influence on BDNF signaling in the hippocampus.
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The incidence of mild to severe levels of spontaneous bleeding due to the usage of selective serotonin reuptake inhibitors (SSRIs) is relatively low. Although the exact mechanism is not known, it is thought that inhibition of the serotonin transporter together with a decrease in platelet serotonin could be responsible for the bleeding. Therefore, the use of SSRIs in conjunction with anti-aggregants may predispose to or exacerbate the risk of bleeding. In this case report, we describe a 44-year-old female patient with a diagnosis of anxiety disorder who spontaneously developed periorbital purpura during treatment with sertraline.
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To examine the time course of central and peripheral neurochemical effects of sertraline (SER) in non-human primates.
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CYP2B6*4 (rs 2279343; 785A > G), CYP2B6*9 (516G > T; rs 3745274), CYP2B6*6 (516G > T + 685G > A) CYP2C19*2 (rs 4244285; 685G > A), CYP2C19*17 (rs 11188072; -3402C > T), polymorphisms were analyzed by polymerase chain reaction and restriction fragment length polymorphism. Plasma concentrations were measured by high-performance liquid chromatography in patients treated with SERT.
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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.
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Ten patients dropped out of the study from each treatment arm. There was a significant, marked improvement in HAM-D and MADRS scores in each group by the treatment endpoint. There was no significant difference between PB and sertraline groups on either HAM-D or MADRS at any visit. The response rate was 90% with PB and 92% with sertraline. The remission rate was 70% with PB and 75% with sertraline. All laboratory parameters were within normal limits in all patients. There were no serious adverse events.
Data supporting the use of medications in the treatment of PTSD in children and adolescents are limited. SSRIs show promise and deserve additional study, but conclusive support for their use is not available as it is in adults. Additional research is needed, with other drugs of interest including other antidepressants, alpha-adrenergic agents, and possibly the antiepileptic agent carbamazepine.
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Exfoliative cytology should be the complementary examination of choice in cases of oral ulcers with a suspicion of drug interaction. Although this is a rare event in dental practice, dentists should be aware of the diagnostic possibility of drug-induced ulcers and should cooperate with the clinician to adjust the prescribed medication to resolve the symptoms.