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An isocratic high-performance liquid chromatography (HPLC) method with column switching and ultraviolet (UV) detection is described for quantitative analysis of the new antipsychotic drug ziprasidone. After centrifugation of serum or plasma samples and addition of fluperlapine as internal standard, the samples were injected into the HPLC system. On-line sample clean-up was conducted on a column (10 x 4.0 mm ID) filled with silica C8 material (20-microm particle size) using 8% (vol/vol) acetonitrile in deionized water as eluent. Ziprasidone was eluted and separated on ODS Hypersil C18 material (5 microm; column size 250 x 4.6 mm ID) using acetonitrile-water-tetramethylethylendiamine (50:49.6:0.4, vol/vol/vol). The UV detector was set at 254 nm. Ziprasidone was separated within 20 minutes. The limit of quantification was 10 ng/mL. At therapeutic concentrations, the interassay reproducibility (coefficient of variation) of quality control samples was below 10%. The method was found to be robust and stable. More than 100 serum samples could be analyzed without changing the clean-up column and more than 300 samples using the same analytic column. Among multiple drugs tested for interference, only the tricyclic antidepressants trimipramine and clomipramine were found to exhibit retention times similar to that of ziprasidone. The method was applied to analyze ziprasidone concentrations in blood serum of 67 patients treated with 40 to 280 mg ziprasidone per day for at least 7 days (median 120 mg). The median steady-state serum concentration of ziprasidone was 76 ng/mL, and the 25th and 75th percentile were 43 to 131 ng/mL, respectively. Forty to 130 ng/mL may be considered the recommended target plasma concentration range. HPLC with column switching and UV detection as described here is suitable for therapeutic drug monitoring of ziprasidone.
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Thirty-eight patients with primary obsessive-compulsive disorder participated in a 10-week, double-blind, placebo-controlled trial of the potent, selective serotonin reuptake inhibitor fluvoxamine. Fluvoxamine was significantly better than placebo on two of three measures of improvement in obsessive-compulsive symptoms. The authors also compared studies of the serotonergic agents fluvoxamine, sertraline, fluoxetine, and clomipramine and found that a greater effect size was associated with less serotonergic specificity and that some ability to affect other neurotransmitter systems may be a necessary but not sufficient requirement for antiobsessional activity. These data lend only partial support to a serotonin hypothesis of obsessive-compulsive disorder.
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A population-based case-control study was conducted within a large Dutch primary care database over the period 1996-2005. Cases with endoscopy-confirmed RE were identified and matched with up to 10 controls on gender, age, GP practice, and calendar time. Exposure to TCAs was assessed in the year prior to diagnosis and categorized as current (last prescription covered or ended within one month prior to the index date), past, and no use. The relative risk of RE was estimated by odds ratios (OR) with 95% confidence intervals (95% CI) using multivariate conditional logistic regression analysis.
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The present study (1) reports on the synthesis of two hybrid silica monoliths functionalized with aminopropyl or cyanopropyl groups by the sol-gel process; (2) evaluates these monoliths as selective stationary phase for microextraction by packed sorbent (MEPS) to determine drugs in plasma samples via liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the multiple reactions monitoring (MRM) mode; and (3) discusses important factors related to the optimization of MEPS efficiency as well as the carryover effect. The prepared hybrid silica monoliths consisted of a uniform, porous, and continuous silica monolithic network. The structure of the aminopropyl hybrid silica monolith was more compact than the structure of the cyanopropyl hybrid silica monolith. The Fourier-transform infrared spectroscopy (FTIR) spectra of the hybrid silica monoliths displayed readily identifiable peaks, characteristic of the cyanopropyl and aminopropyl groups. Compared with the aminopropyl hybrid silica phase, the cyanopropyl hybrid silica phase exhibited higher binding capacity for most of the target drugs. The developed method afforded adequate linearity at concentrations ranging from the lower limit of quantification (0.05-1.00 ng mL(-1)) to the upper limit of quantification (40-10,500 ng mL(-1)); the coefficients of determination (r(2)) were higher than 0.9955. The precision of the method presented coefficients of variation (CV) lower than 14%; the relative standard error (RSE) of the accuracy ranged from -12% to 14%. The developed method allowed for simultaneous analysis of five antipsychotics (olanzapine, quetiapine, clozapine, haloperidol, and chlorpromazine) in combination with seven antidepressants (mirtazapine, paroxetine, citalopram, sertraline, imipramine, clomipramine, fluoxetine), two anticonvulsants (carbamazepine and lamotrigine), and two anxiolytics (diazepam and clonazepam) in plasma samples from schizophrenic patients, which should be valuable for therapeutic drug monitoring purposes.
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Despite the effectiveness of clomipramine and selective serotonin reuptake inhibitors (SSRIs) in the treatment of obsessive-compulsive disorder (OCD), 40% to 60% of patients who receive an adequate treatment with these agents have significant persisting symptoms. Newer atypical antipsychotic drugs showed efficacy as augmenting agents in patients with OCD resistant to serotonin reuptake inhibitors (SRIs). The objective of this study was to evaluate the efficacy and safety of amisulpiride augmentation in treatment resistant OCD. A total of 20 patients diagnosed with OCD according to DSM-IV criteria and having a history of resistance to treatment with SRIs were included in the study. Amisulpiride 200 mg/day was added to ongoing SRI treatment and titrated up to 600 mg/day in flexible doses. The mean amisulpiride dose was 325 +/- 106 mg/day. The patients were assessed with the Yale-Brown obsessive-compulsive scale (Y-BOCS) at baseline and at week 12 of amisulpiride treatment. Side effects were monitored by the UKU side effect rating scale. The reduction in Y-BOCS scores between the baseline (26.7 +/- 6.3) and the end of the treatment (12.5 +/- 2.8) was statistically significant (p=0.0001). The most commonly observed side effects included weight gain (14 patients, 70%), mild sedation (13 patients, 65%) and asthenia (7 patients, 35%). This study has several limitations and, hence, the results are preliminary and require confirmation in a randomized controlled trial. In conclusion, this study suggests that amisulpiride may be a promising option as an augmentation strategy in treatment resistant OCD.
With the aim of identifying predictors of treatment response, plasma levels of tryptophan (Trp) and tyrosine (Tyr) pretreatment and during treatment, and their ratios in plasma to the sum of the other large neutral amino acids (LNAA), were determined in 26 inpatients with major depression. The subjects were treated double-blind on a fixed-dose schedule for 4 weeks with the monoamine oxidase (MAO) inhibitor moclobemide. The study took place at 4 clinical centers. Endogenous and nonendogenous depressives were comparable in all biochemical variables and were therefore analysed together. The levels of plasma Trp/LNAA were decreased pretreatment and during treatment in the depressives compared with healthy controls. No significant correlation between plasma amino acid levels or ratios, or plasma moclobemide level, and clinical improvement was found, and there were no indications of a specific plasma amino acid profile associating with a favourable clinical response. Endogenous depressives showed significantly greater improvement than nonendogenous depressives; however, neither subgroup showed significant correlations between biochemical and clinical variables. The findings are at variance with a series of studies, which showed significant correlations between plasma amino acid ratios and clinical improvement on a variety of antidepressant treatments.
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These findings are consistent with other data suggesting that 5-HT3 receptors do not play a major role in the prolactin response to 5-HT challenge in human subjects, but may mediate nausea associated with enhanced 5-HT neurotransmission.
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We recently observed a 45-year-old patient with a history of psychiatric illness who presented with severe hyperthermia (rectal temperature above 41 degrees C) with intense rhabdomyolysis and liver cytolysis during tetrabenazine therapy for neuroleptic tardive dyskinesia. In addition to tetrabenazine, this patient took lorazepam and two antidepressant drugs: clomipramine, a potent serotonin-reuptake inhibitor, and mianserin. Hyperthermia responded to parenteral sodium dantrolene and oral bromocriptine administration. The significant role of tetrabenazine (a central nervous system dopamine-depleting drug) and the contribution of antidepressants to the mechanism of this neuroleptic malignant syndrome - like hyperthermia are discussed.
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Twenty-five Sprague Dawley rats (250 to 300 gm. each) were equally divided into 5 groups based on experimental agent; normal saline, clomipramine, sertraline, paroxetine, and fluoxetine. The hypogastric nerve was electrically stimulated and the intraluminal pressure of the vas deferens was measured, both pretreatment and 30 minutes after intravenous injection of four different doses (0.1 to 20 x the therapeutic dose) of each agent. Variations of responses relative to the time after administration of each agent (at 10- and 20-fold concentration) were also observed.
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All suspected adverse drug reactions in women and reported from January 1986 until August 1996 to the Netherlands Pharmacovigilance Foundation, a spontaneous adverse drug reaction reporting programme, were analysed. Adverse drug reaction (ADR) reporting odds ratios, defined as the ratio of the exposure odds among reported cases of non-puerperal lactation to the exposure odds of reported other ADRs, were calculated adjusted for age and year of reporting.
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In 2 out of 3 cases of retrograde ejaculation treatment with clomipramine hydrochloride resulted in normal ejaculation and conception. The 3rd patient was only partially helped by the drug. The mechanisms of ejaculation, the causes of retrograde ejaculation, the management of the condition and the relevant pharmacological features of the tricyclic anti-depressants are discussed.
Neuropathic mice exhibited an increased spontaneous rubbing÷scratching of the ipsilateral vibrissal pad, together with enhanced responses to cooling (acetone) and the chemical irritants (formalin, capsaicin). Clomipramine and tramadol produced an antihyperalgesic effect on most of these nociceptive responses, but tramadol was ineffective on capsaicin-induced hyperalgesia.
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Alterations in arginine vasopressin regulation and secretion have been proposed as one possible biochemical abnormality in patients with obsessive-compulsive disorder. In golden hamsters, arginine vasopressin microinjections into the anterior hypothalamus trigger robust grooming and flank marking, a stereotyped scent marking behaviors. The intensity and repetition of the behaviors induced by arginine vasopressin is somewhat reminiscent of Obsessive Compulsive Disorder in humans. The present experiments were carried out to test whether pharmacological agents used to alleviate obsessive compulsive disorder could inhibit arginine vasopressin-induced flank marking and grooming.
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This study examines the predicting factors for absenteeism in depressed patients. Using a 'cross-sectional' design, we observed 345 patients diagnosed with major depressive disorders as assessed by the Diagnostic and Statistical Manual for Mental Disorders, third edition revised (DSM-III-R) criteria and Hamilton Depression Rating Scale (HAM-D)  score higher than 12. The treatment group (n = 268) were treated with antidepressants (n = 98 with fluoxetine and n = 170 with tricyclics [amitriptyline, clomipramine]) for at least one week and the non treated group (n = 67) had not received antidepressants for at least one month. Sociodemographic, clinical and therapeutic data was collected. The primary endpoint was absenteeism from work. Logistic regression analysis of these data was used to identify potential predictive variables. The rate of absenteeism from work was greater in non treated (70.2%) compared to treated patients (39.8% for fluoxetine group and 57.7% for tricyclics group). The risk of absenteeism for patients treated with tricyclics was 2.45 times greater than for patients treated with fluoxetine (odds-ratio = 2.45, CI 95% = 1.1-4.7). For all patients, the strongest predictors of absenteeism from work were symptom severity (odds-ratio = 44.4, CI 95% = 7.9-250) followed by past history of depression (odds-ratio = 6.85, CI 95% = 2.6-18.4) and past history of absenteeism (odds-ratio = 6.51, CI 95% = 2.0-204). In conclusion, the risk of absenteeism from work increases with depression severity and is higher with tricyclics compared to fluoxetine.
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Serotonin significantly decreased serotonergic activity in major cerebral arteries and striatum without affecting it in hippocampus. This reduction was blocked by previous injection of WAY-100635 in DRN. Local administration of 8-OH-DPAT or clomipramine elicited an effect similar to that of serotonin, whereas that of WAY-100635 did not modify serotonergic activity in either of the tissues. Electrical stimulation of DRN significantly increased serotonergic activity in major cerebral arteries and striatum but not in hippocampus.
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In one study (De Carufel 2006) behavioral therapy (BT) was significantly better than waiting list for duration of intercourse (MD (mean difference) 407.90 seconds, 95% CI 302.42 to 513.38), and couples' sexual satisfaction (MD -26.10, CI -50.48 to -1.72). BT was also significantly better for a new functional-sexological treatment (FS) (MD 412.00 seconds, 95% CI 305.88 to 518.12), change over time in subjective perception of duration of intercourse (Women: MD 2.88, 95% CI 2.06 to 3.70; Men: MD 2.52, CI 1.65 to 3.39) and couples' sexual satisfaction (MD -25.10, 95% CI -47.95 to -2.25), versus waiting list.One study (Li 2006) showed that the combination of chlorpromazine and BT was superior than chlorpromazine alone for IELT (MD 1.11, 95% CI 0.82 to 1.40), SAS (Self-rating Anxiety Scale) (MD -8.72, 95% CI -11.09 to -6.35) and for some CIPE (Chinese Index Premature Ejaculation) questions ('anxiety in sexual activity', 'partner sexual satisfaction', 'patient sexual satisfaction', 'control ejaculatory reflex' and 'ejaculatory latency') ('Analysis 1.2').One study (Yuan 2008) showed that citalopram significantly improved IELT (RR (risk ratio) 0.52, 95% CI 0.34 to 0.78) and the number of couples satisfied with their sex life after treatment (RR 0.60, 95% CI 0.39 to 0.93), versus BT.In the last study (Abdel-Hamid 2001), 31 patients received 1 of 4 drugs administered on an as-needed basis 35 hours before anticipated coitus (clomipramine, sertraline, paroxetine, sildenafil), or were instructed to use the pause-squeeze technique. The study consisted of five four-week periods of treatment, separated by two-week washout periods. Anxiety score and ejaculation latency time were measured before treatment, after each treatment and during washout periods. Sexual satisfaction scores were measured after each treatment. However the available data from the article were not sufficient to be included, and the related database was not available anymore, according to the main author.
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In a comparative study of three treatment regimens in patients with obsessive-compulsive or phobic manifestations, the most favourable therapeutic findings were seen in the clomipramine (Anafranil, Geigy Pharmaceuticals) plus behaviour therapy group and the least favourable therapeutic findings in the clomipramine plus simulated behaviour therapy group. The findings that a combination of behaviour therapy and clomipramine results in more favourable therapeutic changes than either of the two treatments alone is in line with reported studies in the literature.
Twenty-three premature ejaculators (PEs) and 11 control subjects were administered 25 mg of clomipramine in a double-blind, placebo-controlled, crossover design study. During 2-week trials, subjects took either the drug or the placebo 4 to 6 hours prior to sexual activity. Daily diary data revealed that, for both groups, orgasmic latency was significantly increased when taking the clomipramine. For the PEs, the average increase in orgasmic latency during intercourse was from less than 1 minute to more than 3.5 minutes. Subjects also participated in two laboratory sessions while on the drug and placebo. During these lab sessions they were exposed to erotic videos with and without the addition of vibrotactile stimulation to the penis. Results from the laboratory data support those from the diaries. Specifically, PEs were significantly less likely to reach orgasm during the lab sessions while on the clomipramine than while on the placebo. Further, they reported a significantly greater sense of control over their orgasm while on the drug. The results of this study, along with previous research, strongly support the value of low doses of clomipramine in the treatment of premature ejaculation, specifically when taken on an as-needed basis as little as 4 hours prior to sexual activity. It is important to note, however, that the beneficial effects of the drug were not uniform across clinical subjects. In this study, those PEs with the shortest orgasmic latencies while on the placebo were the least likely to substantially improve while on the drug. Additional research is necessary to determine whether changes in the timing and dosage of the clomipramine administration can extend the benefits of the drug to those with the shortest latencies.
The potent CYP1A2 inhibitor fluvoxamine has recently been shown also to be an effective inhibitor of the CYP2C19-mediated metabolism of the antimalarial drug proguanil in vivo. The purpose of the present study was to confirm this interaction in vitro.
Obsessions or compulsions that cause personal distress or social dysfunction affect about 1% of men and 2% of women. About half of people with obsessive compulsive disorder (OCD) have an episodic course, whereas the other half have continuous problems. Up to half of people show improvement of symptoms over time.
Patients with multiple sclerosis show higher prevalence of psychiatric disorders compared to general population, that are hardly managed by pharmacotherapy. In the present report a female patient, 44 years old, with diagnosis (according to DSM-IV) of 340 multiple sclerosis, 296.32 major depressive disorder, recurrent, moderate, 292.84 antidepressant-induced mood disorder, with manic features, is described. In this patient depressive symptoms did not respond to a number of drugs, including tricyclic antidepressants, selective serotonine re-uptake inhibitors hand lithium. Moreover, she had hypomanic and manic episodes induced by two different antidepressant, hydroxy-tryptophan and clorimipramine. Until today, only amisulpride (50 mg/die for four months, then 50 mg every two days for two months) has shown a significant effect on depressive symptomatology, moreover, this drug has not induced the occurrence of manic symptoms.
Medication management of obsessive-compulsive disorder (OCD) has consisted of monotherapy with either clomipramine (CMI) or selective serotonin reuptake inhibitors (SSRIs) such as fluvoxamine, paroxetine, or sertraline. Frequently, OCD patients receiving monotherapy experience low treatment response rates and problematic side effects that may result in discontinuation or noncompliance. This open-label case series presents 7 patients (6 male, 1 female) ages 9 to 23 years with OCD who were effectively treated with combination of CMI plus an SSRI. Treatment effects persisted through 5 to 22 months of follow-up from onset of combination therapy. The drug combination was effective in the 2 patients with OCD and no mood/anxiety comorbidity. Side effects appeared in 5 of 7 patients; cardiovascular side effects were the most common adverse effects. Two patients had prolongation of QTc intervals and 2 developed tachycardia while taking CMI and SSRI combinations. Other risks might include serotonin syndrome, manic switch, insomnia, and possibly headaches, EPS, and sexual dysfunction. Recommendations are made to monitor electrocardiograms, CMI blood concentrations, and vital signs in all cases because SSRIs can increase the blood levels of CMI and/or its active metabolite, desmethylclomipramine (DCMI). CMI could also potentially increase SSRI absorption and/or protein binding. The use of CMI and SSRI combination therapy was found to be more effective compared with their monotherapy in all 7 cases.
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Polymorphisms in genes coding for drug metabolizing enzymes, such as the cytochrome P450 enzymes CYP2C19 and CYP2D6, can lead to therapy failure and side effects. In earlier studies, the novel variant CYP2C19*17 increased metabolism of several CYP2C19 substrates. The objective of this study was to evaluate the impact of CYP2C19*17 on the metabolism of amitriptyline (AT), citalopram (CIT), and clomipramine (CLOM). Six-hundred and seventy-eight patients were included in this study, based on availability of DNA and serum levels of parent drug and main metabolite. We investigated the relationship between CYP2C19 genotypes and metabolic parameters, including serum levels corrected for dose and metabolic ratio (MR). The CYP2C19*17 allele was significantly associated with decreased MR for CIT (CYP2C19*1/*17 mean MR=2.3, compared with CYP2C19*1/*1 mean MR=2.8) and AT (CYP2C19*17/*17 mean MR=0.8, compared with CYP2C19*1/*1 mean MR=3.7 in the CYP2D6*1/*1 subgroup). Furthermore, significant association of CYP2D6 genotype with AT, CIT, and CLOM metabolism was observed. No clear correlation was found between CYP2C19 genotype and CLOM metabolism. This study confirms the increased activity of the CYP2C19*17 allele and shows increased metabolism of drugs that are metabolized by CYP2C19, including AT and CIT. However, the clinical relevance of CYP2C19*17 is probably limited for AT, CIT, and CLOM.
We used the Structured Interview for DSM-III Personality Disorders to diagnose DSM-III personality disorders systematically in 55 patients with obsessive-compulsive disorder in the active-treatment cell of a controlled trial of clomipramine hydrochloride. Patients with a cluster A personality disorder had significantly higher obsessive-compulsive disorder severity scores at baseline, and the number of personality disorders was strongly related to baseline severity of obsessive-compulsive disorder symptoms. At the conclusion of the 12-week study, we found no significant difference in treatment outcome with clomipramine between those patients with at least one personality disorder and those with no personality disorders. However, the presence of schizotypal, borderline, and avoidant personality disorders, along with total number of personality disorders, did predict poorer treatment outcome. These variables were strongly related to having at least one cluster A personality disorder diagnosis, which was also a strong predictor of poorer outcome. Implications of these findings are discussed.
Twenty patients diagnosed with OCD according to DSM-IV TR criteria and having a history of resistance to standard pharmacological treatment were included in the study. Aripiprazole was added to ongoing SSRI or clomipramine treatment with a starting dose of 5 mg/day and titrated up to a maximum of 20 mg/day (mean dose 12.62 mg ± 4.25). Efficacy was assessed with the Yale-Brown obsessive compulsive scale (Y-BOCS) and the Clinical Global Improvement-severity scale (CGI-S) at baseline and at week 12 of Aripiprazole augmentation. Side effects were monitored by the Udvalg for Kliniske Undersogelser (UKU) side effect rating scale.