Double blind, controlled study of the efficacy and safety of alpidem in the treatment of anxiety in schizophrenic in-patients.
Identifieur interne : 003326 ( Main/Exploration ); précédent : 003325; suivant : 003327Double blind, controlled study of the efficacy and safety of alpidem in the treatment of anxiety in schizophrenic in-patients.
Auteurs : M G Minervini [Italie] ; P. Priore ; A. Farolfi ; B. Cesana ; P L MorselliSource :
- Pharmacopsychiatry [ 0176-3679 ] ; 1990.
English descriptors
- KwdEn :
- Adult, Aged, Anti-Anxiety Agents (adverse effects), Anti-Anxiety Agents (therapeutic use), Anxiety (drug therapy), Anxiety (etiology), Anxiety (psychology), Double-Blind Method, Female, Humans, Imidazoles (adverse effects), Imidazoles (therapeutic use), Male, Middle Aged, Psychiatric Status Rating Scales, Pyridines (adverse effects), Pyridines (therapeutic use), Randomized Controlled Trials as Topic, Schizophrenia (complications), Schizophrenic Psychology.
- MESH :
- chemical , adverse effects : Anti-Anxiety Agents, Imidazoles, Pyridines.
- chemical , therapeutic use : Anti-Anxiety Agents, Imidazoles, Pyridines.
- complications : Schizophrenia.
- drug therapy : Anxiety.
- etiology : Anxiety.
- psychology : Anxiety.
- Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Randomized Controlled Trials as Topic, Schizophrenic Psychology.
Abstract
In this double-blind study, alpidem, a new imidazo-pyridine anxiolytic drug, was compared with placebo in order to test its efficacy and safety in chronic schizophrenic in-patients suffering from anxiety not directly related to the schizophrenic process. Sixty-six patients aged from 18 to 65 entered the trial. They also scored at least 18 on the Hamilton Rating Scale for Anxiety (HRSA) after a seven-day placebo run-in. Improvement in symptoms was evaluated by means of the HRSA, the Brief Psychiatric Rating Scale (BPRS), a Visual Analogue Scale (VAS), and the Clinical Global Impression score (CGI). Thirty-three patients were randomly allocated to alpidem and 33 to placebo. Alpidem was significantly more effective (P less than 0.0001) than placebo in improving HRSA scores (total score and factorial scores for somatic and psychic anxiety), BPRS, and VAS. Considering the results of CGI at 21 day, more patients were moderately to markedly improved on alpidem (30/33) than on placebo (2/33) (P less than 0.0001). The efficacy index, according to CGI, was significantly better (P less than 0.001 at least) for alpidem than for placebo. Side-effects were negligible in both groups.
DOI: 10.1055/s-2007-1014491
PubMed: 1971117
Affiliations:
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Le document en format XML
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Farolfi</name></author><author><name sortKey="Cesana, B" sort="Cesana, B" uniqKey="Cesana B" first="B" last="Cesana">B. Cesana</name></author><author><name sortKey="Morselli, P L" sort="Morselli, P L" uniqKey="Morselli P" first="P L" last="Morselli">P L Morselli</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="1990">1990</date><idno type="RBID">pubmed:1971117</idno><idno type="pmid">1971117</idno><idno type="doi">10.1055/s-2007-1014491</idno><idno type="wicri:Area/PubMed/Corpus">000777</idno><idno type="wicri:Area/PubMed/Curation">000777</idno><idno type="wicri:Area/PubMed/Checkpoint">000730</idno><idno type="wicri:Area/Ncbi/Merge">000633</idno><idno type="wicri:Area/Ncbi/Curation">000633</idno><idno type="wicri:Area/Ncbi/Checkpoint">000633</idno><idno type="wicri:doubleKey">0176-3679:1990:Minervini M:double:blind:controlled</idno><idno type="wicri:Area/Main/Merge">003471</idno><idno type="wicri:Area/Main/Curation">003326</idno><idno type="wicri:Area/Main/Exploration">003326</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Double blind, controlled study of the efficacy and safety of alpidem in the treatment of anxiety in schizophrenic in-patients.</title><author><name sortKey="Minervini, M G" sort="Minervini, M G" uniqKey="Minervini M" first="M G" last="Minervini">M G Minervini</name><affiliation wicri:level="1"><nlm:affiliation>Department of Psychiatry Opera Don Uva Hospital, Bisceglie, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Psychiatry Opera Don Uva Hospital, Bisceglie</wicri:regionArea><wicri:noRegion>Bisceglie</wicri:noRegion></affiliation></author><author><name sortKey="Priore, P" sort="Priore, P" uniqKey="Priore P" first="P" last="Priore">P. Priore</name></author><author><name sortKey="Farolfi, A" sort="Farolfi, A" uniqKey="Farolfi A" first="A" last="Farolfi">A. Farolfi</name></author><author><name sortKey="Cesana, B" sort="Cesana, B" uniqKey="Cesana B" first="B" last="Cesana">B. Cesana</name></author><author><name sortKey="Morselli, P L" sort="Morselli, P L" uniqKey="Morselli P" first="P L" last="Morselli">P L Morselli</name></author></analytic><series><title level="j">Pharmacopsychiatry</title><idno type="ISSN">0176-3679</idno><imprint><date when="1990" type="published">1990</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Anti-Anxiety Agents (adverse effects)</term><term>Anti-Anxiety Agents (therapeutic use)</term><term>Anxiety (drug therapy)</term><term>Anxiety (etiology)</term><term>Anxiety (psychology)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Imidazoles (adverse effects)</term><term>Imidazoles (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Psychiatric Status Rating Scales</term><term>Pyridines (adverse effects)</term><term>Pyridines (therapeutic use)</term><term>Randomized Controlled Trials as Topic</term><term>Schizophrenia (complications)</term><term>Schizophrenic Psychology</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anti-Anxiety Agents</term><term>Imidazoles</term><term>Pyridines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Anxiety Agents</term><term>Imidazoles</term><term>Pyridines</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Schizophrenia</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Anxiety</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Anxiety</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Anxiety</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Psychiatric Status Rating Scales</term><term>Randomized Controlled Trials as Topic</term><term>Schizophrenic Psychology</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In this double-blind study, alpidem, a new imidazo-pyridine anxiolytic drug, was compared with placebo in order to test its efficacy and safety in chronic schizophrenic in-patients suffering from anxiety not directly related to the schizophrenic process. Sixty-six patients aged from 18 to 65 entered the trial. They also scored at least 18 on the Hamilton Rating Scale for Anxiety (HRSA) after a seven-day placebo run-in. Improvement in symptoms was evaluated by means of the HRSA, the Brief Psychiatric Rating Scale (BPRS), a Visual Analogue Scale (VAS), and the Clinical Global Impression score (CGI). Thirty-three patients were randomly allocated to alpidem and 33 to placebo. Alpidem was significantly more effective (P less than 0.0001) than placebo in improving HRSA scores (total score and factorial scores for somatic and psychic anxiety), BPRS, and VAS. Considering the results of CGI at 21 day, more patients were moderately to markedly improved on alpidem (30/33) than on placebo (2/33) (P less than 0.0001). The efficacy index, according to CGI, was significantly better (P less than 0.001 at least) for alpidem than for placebo. Side-effects were negligible in both groups.</div></front></TEI><affiliations><list><country><li>Italie</li></country></list><tree><noCountry><name sortKey="Cesana, B" sort="Cesana, B" uniqKey="Cesana B" first="B" last="Cesana">B. Cesana</name><name sortKey="Farolfi, A" sort="Farolfi, A" uniqKey="Farolfi A" first="A" last="Farolfi">A. Farolfi</name><name sortKey="Morselli, P L" sort="Morselli, P L" uniqKey="Morselli P" first="P L" last="Morselli">P L Morselli</name><name sortKey="Priore, P" sort="Priore, P" uniqKey="Priore P" first="P" last="Priore">P. Priore</name></noCountry><country name="Italie"><noRegion><name sortKey="Minervini, M G" sort="Minervini, M G" uniqKey="Minervini M" first="M G" last="Minervini">M G Minervini</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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