Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

1. The present study evaluated the safety and efficacy of two dosages of SC 48,274 (1mg and 25mg) as compared to placebo in subjects with Generalized Anxiety Disorder (GAD). 2. This was a randomized, double-blind, placebo-controlled, parallel-group study which was part of one of three large multicenter trials which evaluated a total of 5 doses of SC 48,274 (.25, 1, 5, 25, and 100mg bid). Following a 7-day placebo baseline period, patients entered 4 weeks of double-blind treatment and a 7-day placebo follow-up period. 3. Efficacy was assessed weekly throughout the study with the Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression (CGI), and at treatment endpoint with the Covi Anxiety Scale, Raskin Depression Scale and Hamilton Depression Rating Scale (HAM-D). A diagnosis of GAD according to DSM-III-R criteria (with the exception that a GAD minimum duration of 3 months was allowed), a HAM-A score > or = 20 (anxious mood and tension items > or = 2), HAM-D less than HAM-A, Covi Anxiety Score > or = 8, Raskin Depression Scale less than the Covi Anxiety, and age of 18 to 65 years were necessary for inclusion in the study. 4. Patients received one of two dosages of SC 48,274, either 1mg (n = 28), 25mg (n = 9), or placebo (n = 28) bid, during the 4-week randomized portion of the trial. 5. Mean changes from baseline in HAM-A scores for the 1mg, 25mg, and placebo groups after 4 weeks treatment were -5.1, -4.2, and -1.9, respectively. Changes were significant for the 1mg group vs. placebo (F = 8.93, p = 0.004), but not for the 25mg group (F = 2.26, p = 0.138). 6. CGI severity of illness scores were also significant for the 1mg group versus placebo at the end of treatment (X2 = 3.8, p = 0.05), but not for the 25mg group (X2 = 0.90, p = 0.343). Neither group showed significant CGI improvement scores by end of treatment. 7. The most frequent adverse events associated with the study drug (n = 37) were headache (n = 7), nausea (n = 3), palpitations (n = 4) and chest pains (n = 2). There was, however, no apparent pattern of adverse events distinguishing SC 48,274 from placebo.
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PMID:An evaluation of the anxiolytic SC 48,274 in generalized anxiety disorder (GAD) 793 70

Panic attack symptomatology was investigated in 212 panic disorder patients (60 men, 152 women) using the Panic Attack Questionnaire, Feelings of helplessness and thoughts of escape had the highest mean severity ratings, but are not currently listed in the DSM-III-R. The DSM-III-R symptoms labeled choking or smothering sensations, paresthesias, nausea, and chest pain had low severity ratings. Evidence was obtained for a three-factor model of panic symptomatology consisting of dizziness-related symptoms, cardiorespiratory distress, and cognitive factors. These results provide only limited support for the current DSM-III-R symptom structure, and support the notion that panic disorder is a heterogeneous condition.
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PMID:The symptom structure of panic attacks. 799 26

In a double-blind multi-centre study of general practice patients with DSM-III-R major depressive disorder, sertraline (50 or 100 mg/day) was compared with dothiepin (75 or 150 mg/day) and with placebo. There were 83, 96 and 90 patients evaluated in the respective treatment groups; treatment lasted 6 weeks. Patients were assessed on the MADRS, CGI, and Leeds Self-rating Scales. Statistically significant differences (p < 0.05) between sertraline and placebo were found on MADRS and CGI but not the Leeds Scales. In the mild subgroup analyses, there were no significant differences between sertraline and placebo. However, clear significant differences (p < 0.05) between sertraline and placebo were present in the severe subgroup. Dothiepin failed to achieve a statistically significant difference from placebo on any analyses. Seventy-six per cent of patients were treated with 50 mg sertraline and 81% of patients received 150 mg dothiepin. Both sertraline and dothiepin were generally well tolerated; the most frequent side effects with sertraline were nausea, dizziness and headache; with dothiepin the most frequent side effects were dry mouth, somnolence and headache.
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PMID:A double-blind, placebo-controlled comparison of sertraline and dothiepin in the treatment of major depression in general practice. 805

Seventy-seven patients with a primary diagnosis of social phobia (DSM-III-R) were randomized to treatment with the reversible and selective monoamine oxidase type A inhibitor brofaromine (n = 37) or placebo (n = 40) for 12 weeks in a double-blind trial. A fixed dose of 150 mg/day or a matching placebo was given after a 2-week dose titration phase. Patients with additional diagnoses of simple phobia, generalized anxiety disorder, dysthymia or major depressive disorder currently in remission were accepted. Patients with other Axis I mental disorders were excluded. In the brofaromine group, 78% of the patients scored much or very much improved on the Clinical Global Impression scale compared with 23% in the placebo group. The anxiety and avoidance scores on the Liebowitz Social Anxiety Scale (LSAS) were significantly reduced in favor of brofaromine. The clinical effects were not significantly correlated with the plasma concentration of brofaromine. After 12 weeks the brofaromine group scored significantly lower than the placebo group on a core depression part of the Montgomery-Asberg Depression Rating Scale. After 12 weeks of treatment the brofaromine group had significantly higher total scores on the LSAS than an age- and gender-matched group of healthy controls. The brofaromine group improved further during 9-month follow-up treatment period, whereas 60% of the placebo responders who continued long-term treatment relapsed. The most common side effects in the brofaromine group were sleep disturbances, dry mouth and nausea.
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PMID:Social phobia: the clinical efficacy and tolerability of the monoamine oxidase -A and serotonin uptake inhibitor brofaromine. A double-blind placebo-controlled study. 861 39

The authors present the results of the treatment with methylphenidate in 24 children with attention deficit disorder based on DSM-III. The prescribed dose was 5 to 10 mg per day, once or twice a day. The results were good in 79.1% of the patients and poor in 16.6%. The drug was withdrawn in one patient because of side effects and the evaluation of efficacy was not possible. Side effects occurred in 2 children (headache and/or nausea). The therapeutic response and the side effects are compared with the literature. The authors claim attention to the efficacy and safety of the treatment with methylphenidate.
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PMID:[Attention deficit disorder: treatment with methylphenidate]. 873 40

This multicenter, double-blind, placebo-controlled, parallel-group, randomized study assessed the efficacy, safety, and tolerability of a novel CCK-B antagonist CI-988 in the treatment of generalized anxiety disorder (GAD). Patients received placebo or CI-988 (300 mg/day, thrice daily) for 4 weeks. Patients with a primary diagnosis of GAD according to DSM-III-R criteria were randomized. The study design included a 1- to 2-week single-blind placebo baseline phase, followed by a 4-week double-blind treatment phase. Efficacy was measured weekly by Hamilton Rating Scale for Anxiety (HAM-A), Clinical Global Impressions of Severity and Change, UCLA-Multi Dimensional Anxiety Scale, and Hamilton Rating Scale for Depression. Patients were also evaluated to determine whether they met criteria for irritable bowel syndrome (IBS) at screening and were evaluated with a gastrointestinal visual analog scale at each visit. Eighty-eight patients were randomized to CI-988 (N = 45) and placebo (N = 43) at three centers. CI-988 did not demonstrate an anxiolytic effect superior to placebo in this clinical trial. There was no significant difference in mean change in HAM-A total between placebo (-7.73) and CI-988 (-8.64). However, a significant treatment-by-center interaction and a highly variable placebo response rate among the three centers limit the interpretation of the results. CI-988 did not have an effect on symptoms of IBS other than diarrhea, which worsened in patients with IBS. Other than a higher incidence of some gastrointestinal symptoms (diarrhea, dyspepsia, flatulence, and nausea), CI-988 was well tolerated. Results suggest that testing higher oral doses of CI-988 may be warranted.
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PMID:A double-blind, placebo-controlled study of a CCK-B receptor antagonist, CI-988, in patients with generalized anxiety disorder. 874 32

Approximately 20 million patients suffer from major depressive disorder each year, indicating a need for antidepressant agents that are synonymous with effectiveness, tolerability and patient compliance. The authors examined the effects of fluvoxamine, a selective serotonin reuptake inhibitor, in the treatment of outpatients meeting DSM-III-R criteria for major depressive disorder. A randomized, double-blind, parallel group, placebo- and imipramine-controlled single center study was conducted in 150 outpatients. Patients were randomized to receive up to 150 mg/day of fluvoxamine as a single bedtime dose, 240 mg/day of imipramine on a twice-daily (BID) schedule, or placebo for six weeks. Efficacy measurements included HAM-D, MADRS, CGI, Raskin-Covi and SCL-56 scales. The HAM-D total score indicated that both active treatment groups showed significantly (p < or = 0.05) greater therapeutic benefit than did placebo. Severely depressed patients (HAM-D > or = 30) responded better to fluvoxamine in five of six measures. Side-effects from fluvoxamine were similar to those reported for other selective serotonin reuptake inhibitors (nausea, somnolence) and were well tolerated. Imipramine was associated with anticholinergic effects such as dry mouth and dizziness. The pharmacokinetic properties of fluvoxamine which allow the drug to be administered as a single daily dose should aid in the maintenance of patient compliance, while offering significant clinical benefit in the improvement of depressive symptoms.
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PMID:Fluvoxamine versus imipramine and placebo: a double-blind comparison in depressed patients. 880 49

Patients meeting the social phobia criteria of the revised third edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R) on the DSM-III-R Structured Clinical Interview (n = 101) entered a long-term moclobemide treatment study. These patients were treated for 2 years with moclobemide (phase I) followed by drug withdrawal, in most cases abruptly (phase II). Those who relapsed entered phase III for a further period of 2 years of treatment. During phase I 40 patients (39.6%) withdrew due to inefficacy or relapse. Two patients were removed from the study because of other diagnoses (borderline or schizophreniform). At the end of phase I the remaining patients (58.4%) were rated as not ill (45.5%) or minimally ill (11.9%). Effort was taken to achieve the maximum dose of moclobemide (750 mg/day) and the mean (+/-SD) dose was 723.3 +/- 67.7 mg/day (month 21). A marked decrease in symptoms in the patients who responded was recorded on the Liebowitz Scale for Social Phobia, Clinical Global Impressions. Hamilton Anxiety Scale and Hamilton Depression Scale. Non-response was mainly associated with co-morbidity, especially alcohol abuse, axis II disorders, and a history of major depression or secondary dysthymia. The drug was well tolerated; the more frequent side effects were mild and occurred mainly in the first 2 months of phase I, including nausea, headaches or insomnia. In phase II there was a relapse rate of 88% and 51 patients entered phase III; these patients are still being treated.
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PMID:The long-term treatment of social phobia with moclobemide. 892 15

Following the conduct of a 28-day inpatient bioequivalence study of clozapine in schizophrenia patients, withdrawal effects after abrupt discontinuation from clozapine were assessed. Thirty patients who met DSM-III-R criteria for schizophrenia, residual type, or schizophrenia in remission were enrolled in the study. Patients were evaluated for symptoms of withdrawal effects for 7 days after clozapine 200 mg/day was abruptly withdrawn. Of 28 patients who completed the study, 11 had no withdrawal symptoms; 12 had mild withdrawal adverse events of agitation, headache, or nausea; four patients experienced moderate withdrawal adverse events of nausea, vomiting, or diarrhea; and one patient experienced a rapid-onset psychotic episode requiring hospitalization. Cholinergic rebound is a likely explanation for the mild to moderate withdrawal symptoms and is easily treated with an anticholinergic agent. Mesolimbic supersensitivity, as well as specific properties of clozapine, are discussed as likely causes for rapidonset psychosis. Our findings are consistent with previous reports of withdrawal reactions associated with clozapine, further reminding clinicians to monitor patients closely following abrupt discontinuation of clozapine.
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PMID:Cholinergic rebound and rapid onset psychosis following abrupt clozapine withdrawal. 893 13

Fifteen consecutive patients with a DSM-III-R diagnosis of body dysmorphic disorder (BDD) were included in a 10-week open clinical trial of fluvoxamine. Treatment began at 100 mg/day fluvoxamine and was increased to a maximum of 300 mg/day or until intolerable side effects developed or a complete or nearly complete resolution of symptoms occurred. At baseline and at weeks 2, 6 and 10, patients completed the Hopkins Symptoms Check-List (HSCL-90) and a specific rating scale for BDD symptoms (BDDSS), and clinicians completed a Clinical Global Improvement Scale. Twelve of the 15 patients completed the trial. Of the three patients who did not complete the study, one improved moderately during the placebo phase, one showed a marked worsening of the depressive symptoms during the wash-out phase and one showed adverse side effects, such as nausea and diarrhoea, after the first week of treatment and was unable to continue the trial. After 10 weeks, of the 12 remaining patients, 10 were considered to be markedly improved, one minimally improved and one unchanged. Several outcome measures showed a significant improvement from baseline to week 10. Our findings suggest that fluvoxamine may be effective in the treatment of BDD. Double-blind studies will be required to investigate these findings further.
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PMID:Fluvoxamine in the treatment of body dysmorphic disorder (dysmorphophobia). 903 91


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