Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0085631 (agitation)
 12,064 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

1. In a multicenter, placebo-controlled, double-blind clinical trial in 156 elderly patients with psychopathologic symptoms, glycosaminoglycan polysulfate was found to be a therapeutically effective agent in the treatment of the earliest manifestations of a dementing process. 2. Treatment with glycosaminoglycan polysulfate in the daily dosage of 600 LRU, administered on the basis of a divided dosage schedule for 24 weeks, was significantly superior to an inactive placebo on several outcome measures including the SCAG Total and factor scores (i.e., Cognitive Dysfunction, Withdrawal, Agitation/Irritability and Depression), the NOWLIS Total and Fatiguability factor scores, the MMSE, the HAM-D Total and Vegetative Symptoms factor score and the CGI Severity of Illness and Global Improvement. 3. The drug was well tolerated; vital signs and laboratory measures did not show clinically significant changes within the experimental period.
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PMID:Early manifestations of dementing illness: treatment with glycosaminoglycan polysulfate. 137 39

Akathisia usually consists of two components, subjective restlessness and typical movements such as shuffling of the legs, pacing, shifting weight from one leg to the other, and rocking movements of the trunk. The ability to measure akathisia reliably is essential for the assessment of treatments for akathisia and for the evaluation of drug-induced side effects in general. To date, investigators have generally used self-constructed assessment scales without reporting data about reliability or validity. The Hillside Akathisia Scale (HAS) has two subjective and three objective items for which anchored rating points are provided. Reliability was 0.89 for the HAS total score. Reliability for rating subjective symptoms ranged from 0.86 to 0.92, and the objective scores ranged from 0.51 to 0.89. The correlation between HAS and a global assessment of akathisia (modified CGI) was 0.87. These values compare favorably with the original report on the scale indicating that the Hillside Akathisia Scale can validly quantify akathisia with a satisfactory degree of interrater reliability.
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PMID:The Hillside Akathisia Scale: a reliability comparison of the English and German versions. 174 8

Fluvoxamine, a selective serotonin reuptake inhibitor, was investigated in a 6-week double-blind study among severely ill inpatients with DSM-III major depression. All but 1 patient also fulfilled criteria for melancholia. Following a 3-day placebo wash-out patients were randomly assigned to fluvoxamine, imipramine or placebo. Sixty of 81 patients completed at least 2 weeks following wash-out and were evaluated for efficacy. Analysis of covariance (controlling for baseline scores) showed significant (p less than 0.05) differences on CGI severity and BPRS total and a similar trend (p = 0.08) on the Hamilton Depression Scale. Fluvoxamine was superior (p less than or equal to 0.02) to both placebo and imipramine on these measures. Fluvoxamine's most common adverse effects were nausea and agitation. The number of fluvoxamine patients withdrawn for side-effects was less than imipramine and not significantly different than placebo. Fluvoxamine was not associated with significant changes in vital signs, ECG or laboratory tests. The results therefore indicate that fluvoxamine is a safe and highly effective treatment for hospitalized patients with major depression.
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PMID:A placebo-controlled inpatient comparison of fluvoxamine maleate and imipramine in major depression. 250 30

Our study investigated the effects of light therapy on mainly endogenously depressive patients. We applied white fluorescent light of 1500-2000 lux for a length of 4-6 hours daily. For 10 days no antidepressants or sleeping pills were given. We observed a quick and substantial improvement of depressive symptoms within 3 to 5 days. 9 patients showed a very good and 5 patients a good remission of symptoms. This corresponds to an improvement of 65% and is comparable to the effects of antidepressants. The improvement however with light is more rapid and more intensive, the main improvement is to be seen until the 5th day of treatment. No influence was found on vital signs or laboratory values. The rare side-effect was an increase in general drive and activity, which was perceived as agreeable however, and did not take the character of restlessness. Two times an increase of sexual drive was reported. The patients' self-rating concerning vital energy and concentration improved along with the values of the HDRS and CGI as with the quality of sleep. In general patients found light therapy to be agreeable. 1 patient only minimally improved (295.7). No improvement was to be seen in 5 patients (4 x 296.1, 309.1). From our findings we can conclude that light therapy in our patients had the same therapeutic efficacy as tricyclics. In our study the antidepressive effect of light could be maintained with Amitriptylin. Unlike other authors we did not observe a relapse into depression in the responders after ending light therapy.
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PMID:The influence of light therapy in depressive patients. 324 80

The authors report the results of an open clinical trial with Cis(Z)-Clopenthixol (Cisordinol), the isolated Cis-isomer of the Clopenthixol racemate (Sordinol). The drug was applied to 18 patients with severe forms of manic or schizophrenic disease, diagnosed according to ICD 9. The compound was applied intravenously or orally, daily doses ranging from 10-160 mg. For the duration of the study (6 weeks) the patients were repeatedly rated with the CGI, BPRS or IMPS (abbreviated version), and several hematological and enzyme patterns, cardiac, renal function and electrolytes were monitored, as was the FFA. Due to the relatively small number of patients in relatively heterogeneous diagnostic composition, a number of items rated failed to reach statistical significance. The CGI showed a good therapeutic effect with a minimal incidence or severity of side effects. BPRS and IMPS documented an impressive decline in formal thought-disorders, agitation, logorrhea and tenseness. The sedative effects of the drug were slight and of short duration, anti-Parkinson medication was necessary in more than 50% of the patients studied. The results of the study show a good efficacy of the drug in manic and schizophrenic disorders, Cisordinol being well tolerated intravenously. The range of doses administered is approximately 50% of the dose-range of the parent-drug (Sordinol).
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PMID:Findings with cis-Z-clopenthixol in the treatment of acute mania and schizophrenia. 379 70

The results of the meta-analysis of studies comparing the efficacy of moclobemide, imipramine and so-called sedative antidepressants (amitriptyline, mianserin and maprotiline) in 2416 patients are described. The results demonstrated that in agitated-anxious depressive patients (defined by HAMD factor score or HAMD item 9) a nonsedative, reversible MAO-A inhibitor moclobemide has about equal efficacy as imipramine or sedative antidepressants. All antidepressants were clearly superior to placebo, irrespective of the outcome measures applied (> 50% HAMD decrease, CGI improvement). The efficacy of antidepressants in agitated patients was unrelated to the severity of agitation and did not appear to be inferior to the efficacy in nonagitated patients. Comedication with benzodiazepines had no impact on overall efficacy of either moclobemide or other antidepressants in this patient population. Previous treatment with antidepressants, however, always negatively influenced the outcome with trial drugs, e.g., reduced their efficacy. Placebo response in agitated depressives appeared generally to be low (20-30%) and was clearly reduced with increased severity of agitation, irrespectively of how the agitation was defined.
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PMID:Therapeutic efficacy of antidepressants in agitated anxious depression--a meta-analysis of moclobemide studies. 855 84

SCH 39166 is the first selective D1 dopamine receptor antagonist developed for the treatment of schizophrenic patients. To examine potential antipsychotic effect, tolerability and safety, SCH 39166 was given orally to 17 acutely ill drug free schizophrenic patients (DSMIIIR) in an open 4-week study. Doses were escalated from 10 to 100 mg b.i.d. according to a fixed schedule over 17 days and remained at 100 mg b.i.d. for another 11 days. The drug was withdrawn prematurely in ten patients because of deterioration or refusal to take SCH 39166. In the nine patients participating for more than 2 weeks, none had an apparent reduction of BPRS or CGI scores. Side effects were agitation, akathisia and emesis in single patients. After withdrawal of SCH 39166 of the patients improved when treated with classical neuroleptics or clozapine. The result of the study does not support the prediction that selective D1 dopamine receptor antagonism will produce antipsychotic effects in schizophrenia.
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PMID:Lack of apparent antipsychotic effect of the D1-dopamine receptor antagonist SCH39166 in acutely ill schizophrenic patients. 858 11

A major problem in psychogeriatrics is the treatment of demented patients suffering from severe restlessness and aggressive behavior. There have been few controlled studies of the efficacy of antipsychotic drugs in the treatment of this condition. Therefore, a multi-centre, double-blind, randomized study, measuring the efficacy and safety of tiapride vs. melperone in hospitalized dementia patients suffering from psychomotoric agitation, was conducted in 24 psychiatric hospitals in Germany. A total of 176 patients were enrolled: 175 of them were included in the safety analysis and 156 were evaluated for efficacy. Both treatment groups were comparable regarding the severity of disease and demographic data as well as with regard to the neuropsychological baseline assessment. The CGI (item, 2) was the primary efficacy parameter. Both groups yielded an identical response rate of 74.36%. The secondary efficacy parameters (NOSIE, AIMS, RAPSU, BePU, VAS) showed correspondingly a marked improvement for both groups. No significant changes of the safety parameters (blood pressure, pulse rate, ECG, clinical examination) occurred in the study. The overall number of adverse events was slightly higher in the tiapride group, serious events occurring less frequently. This study demonstrates that tiapride is as effective and as safe as melperone. These results are consistent with international experience on tiapride.
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PMID:Measuring the efficacy of psychopharmacological treatment of psychomotoric restlessness in dementia: clinical evaluation of tiapride. 906 63

Depression is associated with considerable morbidity and mortality. As depressive disorders carry a high risk of relapse, treatment strategies include the use of a 6-month continuation period after resolution of the acute episode. Tolerability is of major importance when determining compliance and outcome during long-term therapy. Due to the superior tolerability profile of the selective serotonin reuptake inhibitors (SSRIs) over the older tricyclic antidepressants (TCAs), the former may be more suitable for extended therapy. Comparative studies have not shown differences between the SSRIs in terms of efficacy, but side-effect profiles may vary. A multicenter, double-blind, comparative study of sertraline and fluoxetine was carried out in outpatients fulfilling DSM-III-R criteria for major depressive disorder. Patients were randomised to receive sertraline (50-150 mg, n = 118) or fluoxetine (20-60 mg, n = 120) for 24 weeks. Assessments for depression (HAM-D, HAD, CGI-I, CGI-S), anxiety (Covi), sleep (Leeds Sleep Evaluation scale) and quality of life (SIP) were made at study entry and at weeks 2, 4, 8, 12, 18 and 24. All adverse events were recorded to allow evaluation of tolerability. In total, 88 patients in the sertraline group completed the study compared with 79 in the fluoxetine group. Side effects were responsible for the premature treatment withdrawal of seven (6%) sertraline patients and 12 (10%) fluoxetine patients. Two-hundred and thirty-four patients were included in an ITT analysis up to last visit (116 sertraline, 118 fluoxetine). At study endpoint, both treatments produced a significant improvement over baseline on all efficacy variables (P < 0.001). Although the magnitude of global changes in depression, anxiety, and quality of life was larger with sertraline than fluoxetine, none of the between-group differences reached statistical significance. However, significant differences in favour of sertraline were observed for individual HAM-D items including item 4 (insomnia onset) (P = 0.04), item 9 (agitation) (P = 0.02), and item 13 (general somatic symptoms) (P = 0.008). In addition, sertraline was associated with significantly superior performance on the Leeds Sleep Evaluation scale and on SIP items relating to sleep and rest, emotional behaviour and ambulation. Both sertraline and fluoxetine were well tolerated with no significant differences between treatments.
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PMID:A double-blind comparison of sertraline and fluoxetine in the treatment of major depressive episode in outpatients. 1057 24

There is a widely spread belief that different patients are being recruited into antidepressant clinical trials conducted in Europe and the USA which is probably generated by the fact that recruitment strategies vary between the two continents. In order to get an insight into the patients' characteristics in clinical studies on both continents, we compared the baseline characteristics of depressed patients in a database of a cancelled development program of an antidepressant (2220 patients, Intention-to-Treat group). For the evaluation of continental differences, we compared the elements of demographics, previous psychiatric history, DSM-III-R criteria, HAM-D and MADRS total scores and separate items and/or factors and CGI severity scores at baseline. USA patients had statistically significantly higher baseline values on height, weight and BMI. European patients showed statistically significantly higher baseline severity scores on HAM-D, MADRS and CGI. Furthermore, European patients had statistically significantly higher baseline scores on HAM-D factors I ('anxiety/somatization'), VI ('sleep disturbance'), and HAM-D Angst anxiety/agitation factor, whereas USA patients had a statistically significantly higher baseline value on the Bech depression factor and the HAM-D Angst retarded depression factor. European patients appear to have a more severe depressive episode with more anxiety and melancholic features. Some of the statistically significant differences found may be the result of a large sample size and are probably without any clinical relevance when the absolute size of the difference is taken into account. Our opinion is that the differences found in our sample between European and USA populations are much smaller than is generally expected and not of a magnitude that would question the reliability of the results obtained in our global world-wide, antidepressant drug development program. If our findings were reproducible in other antidepressant databases it would indicate that data gathered in Europe and the USA within a global antidepressant drug development can be pooled.
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PMID:Baseline characteristics of major depressive disorder patients in clinical trials in Europe and United States: is there a transatlantic difference? 1137 36


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