A double-blind controlled trial of pipotiazine, haloperidol and placebo in recently-hospitalized acute schizophrenic patients. 1983

L P Bechelli, and A Ruffino-Netto, and G Hetem

Ninety recently-admitted acute schizophrenic patients, aged 18 to 40 years (mean age: 29) were stratified by schizophrenic subgroups, distributed at random among three groups (pipotiazine, haloperidol and placebo), and evaluated for 27 days by the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression (CGI). All groups received 20 mg of haloperidol and 50 mg of chlorpromazine im during the first 3 days, followed by wash-out for 2 days and then oral pipotiazine, haloperidol or placebo for the following 21 days. The dosage was adjusted to the clinical response of the patients and the mean dose was 21.4 mg for pipotiazine and 11.5 mg for haloperidol. At the end of the trial on the 27th day there was no significant difference between pipotiazine and haloperidol, but the effect of both active drugs was significantly different from that of the placebo. In the period corresponding to the 6th to 27th day, extrapyramidal side effects (EPS) occurred to the same extent in the pipotiazine and haloperidol groups, with predominance of Parkinsonian reactions, and no EPS were observed in the placebo group. Our data for a Brazilian population confirm the only other double-blind study of these drugs reported in the literature.

UI MeSH Term Description Entries
D008297 Male Males
D010640 Phenothiazines Compounds containing dibenzo-1,4-thiazine. Some of them are neuroactive.
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D011569 Psychiatric Status Rating Scales Standardized procedures utilizing rating scales or interview schedules carried out by health personnel for evaluating the degree of mental illness. Factor Construct Rating Scales (FCRS),Katz Adjustment Scales,Lorr's Inpatient Multidimensional Psychiatric Rating Scale,Wittenborn Scales,Edinburgh Postnatal Depression Scale,Mini International Neuropsychiatric Interview
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D006220 Haloperidol A phenyl-piperidinyl-butyrophenone that is used primarily to treat SCHIZOPHRENIA and other PSYCHOSES. It is also used in schizoaffective disorder, DELUSIONAL DISORDERS, ballism, and TOURETTE SYNDROME (a drug of choice) and occasionally as adjunctive therapy in INTELLECTUAL DISABILITY and the chorea of HUNTINGTON DISEASE. It is a potent antiemetic and is used in the treatment of intractable HICCUPS. (From AMA Drug Evaluations Annual, 1994, p279) Haldol
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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