Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
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There is no US Food and Drug Administration (FDA) approved treatment for social phobia although data suggest efficacy for several drug classes, including beta-blockers, benzodiazepines, monoamine oxidase inhibitors, and selective serotonin reuptake inhibitors (SSRIs). The SSRIs are particularly attractive due to their favourable tolerance and safety profile. An open label trial of fluvoxamine was conducted to evaluate its efficacy and safety in the treatment of social phobia (DSM-III-R) and to assess physiological changes that may accompany treatment. Fifteen non-depressed patients, aged 22-44 years (mean 31.6 years), entered the study. A 5-min performance task (public speaking simulation) preceded and concluded the active treatment period. Cardiovascular monitoring was performed during this time and blood sampled for plasma cortisol and steady-state plasma fluvoxamine concentration (at week 7). Ten patients (5 men and 5 women) completed an active 6 week treatment period of flexible dosing (50-150 mg/day). Five patients failed to complete the study due to drowsiness (n = 2), nausea (n = 1), or were lost to follow-up (n = 2). Analysis of clinical ratings indicated a statistically significant decrease in all scales from baseline to week 7 at the conclusion of the active treatment period. Clinical benefits were still evident at follow-up 1 week after drug discontinuation. Neither physiological effects nor plasma drug concentration correlated with clinical change. Fluvoxamine appeared to be effective and well tolerated in completers. Randomized clinical trials are needed to further demonstrate the efficacy of fluvoxamine in the treatment of social phobia.
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PMID:Evaluation of the efficacy, safety and physiological effects of fluvoxamine in social phobia. 1056 1

This was a 6-week, double-blind, randomized trial of the efficacy and tolerability of venlafaxine and fluoxetine in 109 patients with major depression and melancholia. Hospitalized and day care patients with DSM-IV major depression and melancholia and a baseline Montgomery-Asberg Depression Rating Scale (MADRS) score of > or = 25 were eligible. The doses were venlafaxine 75 mg/day or fluoxetine 20 mg/day from days 1-4, venlafaxine 150 mg/day or fluoxetine 40 mg/day from days 5-10, and venlafaxine 225 mg/day or fluoxetine 60 mg/day from days 11-42. The intention-to-treat analyses included 55 patients on venlafaxine and 54 on fluoxetine. At the final evaluation, 70% of patients with venlafaxine and 66% with fluoxetine had > or = 50% reduction in the MADRS score, and 70% with venlafaxine and 62% with fluoxetine had a Clinical Global Impression (CGI) score of 1 or 2. A CGI improvement score of 1 was observed in 51% of patients with venlafaxine and 32% with fluoxetine (P = 0.018). A final Hamilton Depression Rating Scale (HAM-D) score < 7 was attained in 41% of venlafaxine-treated and 36% of fluoxetine-treated patients. Overall, 22% of patients in each group discontinued therapy, but only 5% on venlafaxine and 9% on fluoxetine discontinued for adverse events. Nausea was reported in 5.5% of venlafaxine-treated patients and 14.8% of fluoxetine-treated patients. Venlafaxine was effective and well tolerated for treating inpatients with major depression and melancholia. Based on remission criteria (HAM-D < 7 or CGI of 1), venlafaxine was superior to fluoxetine.
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PMID:Increased remission rates with venlafaxine compared with fluoxetine in hospitalized patients with major depression and melancholia. 1083 83

The common symptoms of the social anxiety response include blushing, trembling, feelings of muscular tension of the face, and fear of eye contact. However, the ICD-10 mentions other less familiar symptoms such as nausea, urgency of micturition or defecation, gastrointestinal discomfort, and diarrhea as symptoms of social phobia. Since some of these somatic symptoms are classified as panic-like symptoms in the DSM-IV, it is sometimes difficult to distinguish between social phobia and agoraphobia when these somatic symptoms appear in situations usually associated with agoraphobia. We investigated whether social phobic patients with familiar symptoms (classical group; N = 24) and those with unfamiliar symptoms such as nausea, urgency of micturition or defecation (N/U group; N = 13) could be distinguished on the basis of several selected demographic and psychological tests. Fear of negative evaluation (FNE), social avoidance and distress (SAD), brief social phobia scale (BSPS), and Rosenberg's self esteem score (Se) were compared among these two groups and 82 controls. We also investigated whether they have "fears of making other people feel uncomfortable" which is believed to be a characteristic symptom for what is known in Japanese as "taijin-kyofu-sho." Both groups had higher scores on FNE, SAD, fear and avoidance scores of BSPS, and lower scores on Se as compared with controls. However, neither group differed in demographic variables or results of psychological tests, except for higher scores on the performance score of BSPS and increased rate of "fears of making other people feel uncomfortable" in the classical group. It is suggested that social phobia patients had common social phobic symptomatology and psychopathology irrespective of their somatic symptoms.
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PMID:[Social phobia with somatic symptoms including nausea and urgency of micturition]. 1089 4

Among somatoform disorders, pain disorder (DSM IV) appears to be relatively common in general practice and to cause social, psychological, and functional impairment. A previous study conducted by Lemoine (1997) has shown that sulpiride is more effective than placebo in reducing intensity and frequency of pain in this disorder. The aim of our study was to assess safety and efficacy of sulpiride in a large sample of patients under natural conditions of use, in general practice. In a multicenter, open clinical trial, 669 patients (mean age: 47 years +/- 12; male: 245, female: 424) fulfilling the DSM IV criteria for pain disorder (of gastrointestinal localization), were included by 321 general practitioners (GP) and treated for 6 weeks with sulpiride 150 mg/d. Investigators' evaluations were planned at D14 and D42. Furthermore a diary was given to each patient for self evaluation and intercurrent events reporting. The pain was of psychological type in 93% of cases and caused social or working disabilities in 78% of patients. At inclusion the mean score of the Hamilton Anxiety Rating Scale was 18 +/- 8, and the mean score of the depression scale HARD (Humeur, Angoisse, Ralentissement, Danger) was 14.8 +/- 6.4. During the study 7.9% of the patients had at least one adverse event, and 3% of patients were withdrawn for adverse event. Safety assessed with a specific variable (grouping together adverse events' reporting and results of CGI item 3) was good for 88% of patients. The principal criterion of efficacy was the clinician's evaluation of the intensity and frequency of abdominal pain on a four-point scale from 0 (asymptomatic) to 3 (important/continuous) from D0 to D End a decrease in pain intensity (91% of patients) and in pain frequency (89%) was observed as well as in frequency and intensity of related gastroenterological symptoms such as disturbances of bowel movements (79% and 78%), bloated symptoms (88% and 83%), nausea/vomiting (90% and 90%). A similar improvement (p < 0.001) was observed from D0 to End point on the self evaluation parameters (Visual Analogic Scales), assessing pain (mean score D0-D End: 17.1 +/- 15.9), quality of sleep (mean score D0-D End: 27.1 +/- 17.8), activity (mean score D0-D End: 24.4 +/- 18.8), and appetite (mean score D0-D End: 22.6 +/- 16.6). In conclusion these results confirm the usefulness of sulpiride in the treatment of pain disorders a symptomatology known to cause difficulties to GP's in their practice.
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PMID:[Sulpiride: study of 669 patient presenting with pain of psychological origin]. 1106 41

An open, baseline controlled study of sertraline in depressed patients was conducted in 6 treatment sites. Eighty-two patients between 20-82 years of age with DSM III-R diagnosis of a depressive illness received sertraline 50-200 mg/day. Among evaluable patients, there was a significant reduction in depressive symptoms at the final visit. A statistically significant change from baseline in Montgomery Asberg Depression Rating Scale (MADRS), Hospital Anxiety Depression Rating Scale (HAD), and Clinical Global Impression Severity of Illness Scale (CGI-S) scores was demonstrated. On the basis of MADRS criterion, 96.0 per cent of patients responded and on the basis of CGI-S criterion, 86.6 per cent of patients responded. In 73.2 per cent of patients the final sertraline dosage was 50 mg. All-cause adverse events were recorded in 35 patients (42.7%), whereas 22 (26.8%) had adverse events that were judged treatment-related. The most frequently reported events were nausea and headache. Overall, the patients tolerated sertraline very well. The results of the study suggest that sertraline is an effective, well-tolerated and safe treatment for depression in Thai patients.
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PMID:An open, baseline controlled evaluation of sertraline safety and efficacy in the treatment of depression in Thai patients. 1128

This study aimed to evaluate the effect of citalopram in patients with refractory obsessive-compulsive disorder (OCD) which had not responded to previous antiobsessional treatments. Eighteen patients were selected for this study: they had been suffering from OCD, according to DSM-IV criteria, for at least 2 years and had various comorbid disorders. All had been treated with serotonin reuptake inhibitors at adequate dosages for at least 6 months, but had failed to respond. Consequently, they were shifted to citalopram, titrated up to the dose of 40 mg, within 2 weeks. After 4 months of this regimen, 14 out of the total of 18 patients had shown a reduction in OC symptoms, as assessed by the decrease in the Yale-Brown Obsessive Compulsive Scale total score; no relevant side-effects were reported, except for a mild nausea in four patients within the first few days of treatment, which quickly disappeared. The use of citalopram would appear to be an useful strategy in refractory OCD cases.
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PMID:Citalopram in refractory obsessive-compulsive disorder: an open study. 1145 35

The present study was designed to test the short-term efficacy and safety of naltrexone in the treatment of pathological gambling disorder. Seventeen subjects (seven men, 10 women) who fulfilled DSM-IV criteria for pathological gambling disorder, and were free from other Axis I diagnoses by Structured Clinical Interview for DSM-III-R screening, participated in a 6-week open naltrexone flexible dose trial. Gambling symptom change was assessed with the patient-rated Clinical Global Impression (CGI) Scale, the clinician-rated CGI and the Gambling Symptom Assessment Scale. Side-effects were monitored weekly and liver function tests biweekly. Naltrexone reduced urges to gamble and gambling behaviour. The mean change in gambling frequency per week was 1.40 +/- 0.28 episodes per week; the mean change in dollars lost per week was $66.95 +/- 13.77; and the mean change in clinician-rated CGI Improvement was 0.40 +/- 0.04. Of those who responded to the medication, the majority had done so by the end of the fourth week. Men responded to naltrexone as well as women. The average naltrexone dose required for effective symptom control was 157 mg/day. Nausea was common during the first week (47%). The present findings provide evidence that naltrexone may be effective in the treatment of pathological gambling disorder. The present report is preliminary and controlled trials are needed to confirm these findings.
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PMID:An open naltrexone treatment study in pathological gambling disorder. 1155 72

This study examined the prevalence of somatic symptoms and psychiatric characteristics of major depression in a Japanese psychosomatic outpatient clinic. A total of 2,215 outpatients referred for mind/body complaints were assessed by DSM-III-R or DSM-IV. Somatic symptoms were rated using the Cornell Medical Index Questionnaire. Ninety-one outpatients (4.1%) were diagnosed with major depression. Prevalence of fatigue (86%), insomnia (79%), nausea/vomiting (50%), and back pain (36%) as well as degrees of psychosocial stress (DSM-III-R axis IV) were higher (all p < 0.05) and scores of global assessment of psychosocial functioning (DSM-III-R/DSM-IV axis V) were lower (p < 0.001) in the major depressive patients compared to the remaining outpatients. Among the major depressive patients, the total number of somatic symptoms was larger (p < 0.05) in patients with 'severe' major depressive episodes than in those with 'mild' depressive episodes. These findings suggest that the level of depression is closely linked to the reporting of somatic symptoms in a psychosomatic medicine population.
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PMID:Major depression and somatic symptoms in a mind/body medicine clinic. 1179 17

Escitalopram, a selective serotonin reuptake inhibitor (SSRI), was compared to placebo in a study of patients with major depressive disorder (DSM-IV) who had baseline Montgomery-Asberg Depression Rating Scale (MADRS) total scores >or=22 and <or=40. After a 1-week, single-blind placebo period, patients were randomized to receive escitalopram 10 mg/day (n=191) or placebo (n=189) in an 8-week, double-blind period. The primary efficacy analysis of adjusted mean change in MADRS total score from baseline showed a statistically significantly larger effect for escitalopram than for placebo with a treatment difference at week 8 (last observation carried forward, LOCF) of 2.7 points (SE 0.85; P=0.002). In further by-week efficacy analyses, the effect of escitalopram was consistently larger than that of placebo (P<0.05) beginning at week 1 (Clinical Global Impression-Improvement score), week 2 (MADRS score) or week 3 (Clinical Global Impression-Severity score). Escitalopram was very well tolerated with a low overall withdrawal rate similar to that for placebo. Nausea was the only adverse event reported significantly more in escitalopram-treated patients than in placebo-treated patients, although it was infrequent and transient. Escitalopram 10 mg/day had a statistically significantly better antidepressant effect than placebo as early as week 1, and was safe and very well tolerated.
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PMID:Escitalopram 10 mg/day is effective and well tolerated in a placebo-controlled study in depression in primary care. 1198 49

Sertraline (SRT) has been shown to be an effective antidepressant in extensive clinical trial programs but data on plasma concentrations regarding clinical outcome and tolerability are lacking. Twenty-one out-patients of both sexes, with mean age of 50.23 years (S.D. = 17.37), affected by major depressive disorder, recurrent (Diagnostic and Statistical Manual of Mental Disorder--IV, DSM-IV), were treated with 25-150 mg of SRT once a day (mean=66.26 mg, S.D.=30.50) for 30 days. Clinical evaluation was assessed at baseline (T0), after 15 days (T15), and then after 30 days (T30). Plasma samples for SRT level determination were collected at T30. Brief Psychiatric Rating Scale (BPRS), Hamilton Rating Scale for Depression (HRS-D), and Hamilton Rating Scale for Anxiety (HRS-A) showed a significant improvement during the study (P<.01 vs. T0). The most commonly reported side effects were nausea (19%), cephalalgia (9.5%), dry mouth (9.5%), decreased libido (9.5%), tremor (4.7%), and tachycardia (4.7%). SRT plasma levels ranged from 2.82 to 112.20 ng/ml (mean=40.42 ng/ml, S.D.=26.93). No correlation between SRT plasma levels and clinical improvement or side effects were observed. Drug plasma level determination does not seem be strictly necessary from a clinical point of view but further research seems advisable in patients at risk like elderly and during long-term studies.
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PMID:Clinical outcome and tolerability of sertraline in major depression: a study with plasma levels. 1199 14


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