APPENDIX A. A PLAN AND A DETAILED BUDGET FOR AN EVALUATION OF THE NEW DRUGS

The table of organization would be as indicated in the scheme below. The National Institute of Mental Health would appoint a director for the project whose responsibility would be to see to the implementation of the proposal. It would be necessary for him to have secretarial assistance and the use of a chief statistician with suitable statistical assistance in setting up the project. The director would select five hospitals encompassing a variety of social and economic milieus. Ratings such as those provided in the NIMH report on psycho-surgery (edited by W. Overholser) might provide such a basis with 1 hospital being drawn from each 20 percentile. It would be necessary that the hospitals be those in which the drugs had not yet been extensively used or where doses had been so low that to all effects and purposes they had not been tried at therapeutic levels. It would also be necessary that the records be adequate for clinical purposes. The director would be responsible for contacting the appropriate State authorities and obtaining their consent and cooperation in the project. At each of these hospitals, a nonphysician administrative assistant to the Director should be appointed from the regular hospital staff and for the duration of the investigation be paid by the project. He should be thoroughly familiar with the hospital's recordkeeping system and it would be his responsibility to undertake the preliminary screening of the records and provide the list of patients who might be suitable for investigation. There also should be appointed at the hospital a liaison medical officer who would be supported by the project, who would review each of the patients to determine whether their current status is such that they actually do meet the criteria. The criteria for inclusion are tentatively suggested as follows:

1. Females: To make the group as homogeneous as possible.

2. Certified patients: This would reduce the likelihood of patients withdrawing from the project after it has been started.

3. Functional psychoses: These should be as nearly classical cases of schizophrenic psychoses as can be obtained.

4. Age range should be from 20 to 45 years; this will help avoid the problem of adolescence or changes which occur with aging.

5. Free of organic disorders: This would eliminate the likelihood that the disease might be due to changes other than the basic psychiatric disorder.

6. First admissions: It is obviously difficult to estimate the duration of illness before admission but in the acute cases particularly, care should be taken to make certain that these are not patients who have been ill for a long time and merely maintained at home.

Although in the final project there should be 40 patients of the chronic disturbed type, 40 patients of the chronic nondisturbed type. 40 of the acute disturbed and 40 of the acute nondisturbed in the preliminary screening at least an additional 50 percent in each group should be provided so that replacements are available if a patient must be discontinued for any reason whatsoever.

It is recommended that each group of 40 patients be placed on one ward so that there is continuity of similar environment and personnel. This would require four separate wards and it is recommended that in order to have careful records that the project provide to the hospital four nurses for each of the wards so that one of them may be on duty at all times. In addition, a secretary would be necessary for maintenance of records and a lab technician with necessary equipment to keep check on possible side effects which require laboratory testing. Once the basic patient group has been selected along with the 50-percent replacement reservoir, a rating team composed of a principal psychiatrist with an associate psychiatrist, a psychologist with an assistant and a social worker should be brought in from outside the hospital. It is recommended that they be drawn from the department of psychiatry at a nearby university medical school but preferably one not ordinarily servicing the hospital in any way. The function of the group is to evaluate the psychiatric and psychological status of each patient. The emphasis should be placed on the social worker to ascertain as far as possible that patients taken into the project would have places in the community if their improvement were sufficient to warrent it.

After evaluation of the patients in respect to their current status and probable prognosis, the patients should be treated for a period of 6 months with adequate doses of the drugs. In the case of the acute patients it is felt necessary for patients not receiving active drugs to be given intensive psychotherapy (a minimum of 3 hours per week for the period during which other patients are placed