Some relevant literature concerning the techniques used to assess psychotropic drug efficacy is evaluated and summarized, and the need for an objective dependent variable to assess behavioral changes associated with drug effects is indicated. The paper concludes that the most obvious basic requirements for the evaluation of psychotropic drugs at the human level are the development and maintenance of stable and reproducible baselines against which to assess drug-correlated changes. As of this date, such a measure has not been developed.
References
1.
BanT. A.Methodology and pitfalls in clinical testing of psychopharmacological drugs. Chemotherapia, 1964, 9, 223–230.
2.
BeaversW. R.Evaluating drugs used in emotional illness. Texas State Journal of Medicine, 1963, 59, 344–347.
3.
BenorD.DitmanK. S.Clinical psychopharmacological research: Problems, questions, and some suggestions in analyzing reports. Journal of Clinical Psychology, 1967, 7, 68–76.
4.
BlochH.What does the laboratory worker expect from clinical trials?Clinical Pharmacology and Therapeutics, 1963, 4, 390–392.
5.
BradyJ. V.Animal experimental evaluation of drug effects upon behavior. Federal Proceedings, 1958, 17, 1031–1042.
6.
BrodieB. B.Difficulties in extrapolating data on metabolism of drugs from animals to man. In ModellW. (Ed.), Symposium on clinical drug evaluation and human pharmacology. St. Louis: Mosby, 1962. Pp. 14–20.
7.
ColeJ. O.Evaluation of drug treatments in psychiatry. Journal of New Drugs, 1962, 2, 264–275.
8.
ColeJ. O.EdwardsR. E.Prediction of clinical effects of psychotropic drugs from animal data. In SteinbergH. S. (Ed.), Animal behavior and drug action. Boston: Little, Brown, 1964. Pp. 113–132.
9.
DavisJ. M.Efficacy of tranquilizing and antidepressant drugs. Archives of General Psychiatry, 1965, 13, 552–572.
10.
DouglasK. W.HindleyJ. P.A comparison of mesoridazine and chlorpromazine in chronic psychiatric patients. Journal of Clinical Psychology, 1969, 9, 176–182.
11.
DunlopE.DeFeliceE. A.BergenJ. R.ResnickO.The relationship between MAO inhibition and improvement of depression. Psychosomatics, 1965, 6, 1–7.
12.
FreeS. M.Factor analysis of outpatient clinical data. Journal of Clinical Pharmacology, 1969, 9, 195–199.
13.
FreemanH. L.LetemendiaF.A review of clinical trials of stelaxine aspects of psychiatric research. New York: Wiley, 1962.
14.
FroschW. A.HektmianL. J.WarwickK. M.FriedhoffA. J.Statistical evaluation of the treatment response assessment method (TRAM) for psychiatric disorders. Journal of Clinical Pharmacology, 1969, 9, 83–90.
15.
GilbertM. M.Clinical evaluation of a new antidepressant drug, protriptyline. International Journal of Neuropsychiatry, 1967, 3, 36–39.
16.
GreenD. M.Clinical proof of safety and effectiveness of proprietary medications. Journal of New Drugs, 1963, 3, 329–337.
17.
HamiltonM.Psychotropic drugs: General considerations. In LasagnaL. (Ed.), International encyclopedia of pharmacology and therapeutics. Oxford, England: Pergamon, 1966. Pp. 181–201.
18.
HarrisL. S.Animal techniques for evaluating psychomotor stimulants. In NodineJ. H.SieglerP. E. (Eds.), Animal and clinical pharmacologic techniques in drug evaluation. Chicago: Year Book Medical, 1964. Pp. 266–271.
19.
HeilzerF.A critical review of some published experiments with chlorpromazine in schizophrenic, neurotic, and normal humans. Journal of Chronic Diseases, 1960, 11, 102–148.
20.
HollisterL. E.Clinical use of psychotherapeutic drugs: Current status. Clinical Pharmacology and Therapeutics, 1969, 10, 170–198.
21.
HollisterL. E.OverallJ. E.Methodology for the clinical investigation of psychotherapeutic drugs. Journal of New Drugs, 1965, 5, 286–293.
22.
HorowitzW. A.Physiologic responses as prognostic guides in the use of antidepressant drugs. American Journal of Psychiatry, 1968, 125, 98–106.
23.
IngelfingerF. J.Clinical judgment in clinical research. In ModellW. (Ed.), Symposium on clinical drug evaluation and human pharmacology. St. Louis: Mosby, 1962. Pp. 73–75.
24.
IrwinS.Drug screening and evaluative procedures. Science, 1962, 36, 123–128.
25.
IrwinS.Determinants of variability in drug response. Psychosomatics, 1964, 5, 174–178.
26.
ItilT.The differentiation of tranquilizers by quantitative EEG. Electroencephalography and Clinical Neurophysiology, 1968, 24, 281–294.
27.
JacobsenM.The use of rating scales in clinical research. British Journal of Psychiatry, 1965, 111, 545–546.
28.
JoyceC. R. B.Psychopharmacology dimensions and perspectives. London: Lippincott, 1968.
29.
KinnardW. J.Jr.WatzmanN.Techniques utilized in the evaluation of psychotropic drugs on animal activity. Journal of Pharmacological Science, 1966, 55, 995–1012.
30.
KlineN. S.Criteria for psychiatric improvement. Psychiatric Quarterly, 1957, 31, 31–40.
31.
KoppanyiT.AveryM. A.Species differences and the clinical trials of new drugs: A review. Clinical Pharmacology and Therapeutics, 1966, 7, 250–270.
32.
LehmannH EThe place and purpose of objective methods in psychopharmacology. In UhrLMillerJ. G. (Eds.), Drugs and behavior. New York: Wiley, 1960. Pp. 107–127.
33.
LitchfieldJ. T.Jr.Evaluation of the safety of new drugs by means of tests in animals. Clinical Pharmacology and Therapeutics, 1962, 3, 665–672.
34.
LorrM.Rating scales, behavior inventories, and drugs. In UhrL.MillerJ. G. (Eds.), Drugs and behavior. New York: Wiley, 1960. Pp. 519–539.
35.
MahonW. A.DanielE. E.A method for the assessment of reports of drug trials. Canadian Medical Journal, 1964, 90, 565–569.
36.
MayP. R. A.Prediction of psychiatric outcome: Animal subjects and individual differences in response—a clinician's view. In WitteabornJ. R.MayP. R. A. (Eds.), Prediction of response to pharmacotherapy. Springfield, Ill.: Thomas, 1966. Pp. 147–155.
37.
MeyersE. L.The food and drug administration's role in the testing of new drugs. Paper read at the meeting of the American Chemical Society, Kalamazoo, Michigan, 1963.
38.
RosenthalR.FodeK. L.The effect of experimenter bias on the performance of albino rats. Behavioral Science, 1963, 8, 183–189.
39.
WechslerH.GrosserG. H.GreenblattM.Research evaluating antidepressant medications on hospitalized mental patients: A survey of published reports. Journal of Nervous and Mental Diseases, 1965, 141, 231–239.
