A Controlled Study of the Use of Thioridazine in the Treatment of Hyperactive and Aggressive Children in a Children's Psychiatric Hospital

Abstract

It is now well recognized that the pa-that if an investigation is worth undertient response associated with the admini-taking there is no point in encouraging srration of medication has many deter-unlimited bias. minants. These include the staff involve-A second vital consideration in the dement and optimism which may be part sign of experiments into the effects of a of a drug investigation, the non-pharm-drug is the need for adequate, objective, acologically derived effect of the med-repeatable and quantifiable measures of ication (the so-called "placebo" effect), change. c?anges in the patient's interp~rsonal.enMuch current drug research is poorly vIronmentwhe0er at home or In hosl;">Ital, designed. Dunham and Howard (7) surwhether -occurrIng by ch~nc: or delIb.er-veyed six psychiatric journals for the fisately .t~rough therapeutI~mtervennon cal years 1957 and 1960 for articles rea~d clinical changes ;:flectII~g the natural porting research on the therapeutic value history of the condition being treated.of energizing and tranquillizing drugs. Gralnick (10) has pointed to the dan-They found that while the total number gers arising from a failure to take these of articles had increased by 36% in 1960, factors into account. Uncritical and ex-"most of the articles in both years and aggerated claims for a new treatment practically all of the increase fall at the method are likely to be followed by an lower levels of methodological adeequally uncritical rejection of the metho? quacy". Collaborative interdisciplinary as a whole, including any real value It research involving trained research workmight have. He warns that the same may ers was highly desirable in psychopharhappen with the new drugs unless they macology, in the authors' view. are subjected to thorough search and Thioridazine, first reported on, clinitudy a.n~unl~ss the treatment approach cally, in 1958 by Fleesan et «1 (8) and IS multidimensional from t?e start.Cohen (6) has since been the subject of !he use of the dou?le-bh~d procedure many reports. Doub.le-blind stud~es comUSIng placebo makes It poss~ble for most paring the drug with placebo In adult of these factors to be taken Into acco.unt, psychiatric patients (8, 14, 15, 29, 31, 1, since their influence will tend to contmue 11, 13) have all shown thioridazine to be whether the patient is taking placebo or more effective than placebo with few drug.side effects. The first five studies includNash (21), in his balanced appraisal of ed adequate objective measures of the double-blind procedure, emphasizes change. Further investigations employing the necessity for the investigator to "an-such measures, but without placebo, (23, ticipate damage to the experiment by fac-34, 37) concluded the drug was effective tors impeding attainment of double-blind and safe. Comparison with other phenoconditions, and to adapt his procedure to thiazines using placebo (8,9,11,14,31)

The Children's Pathology Index*

“…A number of measuring instruments are being developed at Thistletown Hospital (1,2,3,6). One of these, the Children's Pathology Index, (CPI) was developed for use with hospitalized emotionally disturbed children and attempts to quantify the subjective assessments of child-care staff.…”