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                  <text>February 27 , 1967
Dr. Karl Rickels
University of Pennsylvania
School of Medicine
Department of Psychiatry

University Hospital
Philadelphia, Pennsylvania 1910”
Dear Karl,

very pleased that our project has passed another hurdle.
During the past two weeks I have read and re-read your proposed
protocol and would like to share with you some questions and am
enclosing a preliminary budget for your consideration.

I

am

If I understand the proposal, it is to compare two drugs,
alone and canbined with a placebo. Ratings will be done prior
to drug administration, and after two and four weeks of treat—
ment. This is not to be a crossover study and so the number
of patients required will be at least 120. This indicates that
the patient flow in your clinic is indeed large.
From the EEG point of view, the number of subjects and the
sampling will be adequate. In these patients , one consideration
might be that an' initial record taken during the pre-treatment
period should be discarded. In naive subjects, an EEG recording
is often accompanied by considerable anxiety and this is best
alleviated by a recording and the overt demonstration that

it

is without risk.

if we plan

four recordings for each subject, the
500 useful records. From past
should anticipate approximately
we
with
experience
drop-cuts,
one—third more records than we need - for a total of 650 records.
I would like to know
If this is a realistic figure, thenadmissions
what
to the study are,
new
the
patient
approximately
number of
the
weekly
appraise
we
can realistically
so that
records required. The sample length will be determined, in part,
by the number of records to be run. Other things being equal,
I would suggest at least twelve minutes of recording with eyes
closed, and two minutes of eyes opened. The termination of each
recording might be a hyperventilation, with a two minute posteach instance , therecording Will
ation cord.
a east a to 10
ute settling period followed by
a 15 minute actual recording.
Thus,

on

study will have a minimum of

Wen?

�February 27 , 1967
Dr. Karl Rickels
University of Pennsylvania
School of Medicine
Department of Psychiatry

University Hospital
Philadelphia, Pennsylvania 1910”
Dear Karl,

very pleased that our project has passed another hurdle.
During the past two weeks I have read and re-read your proposed
protocol and would like to share with you some questions and am
enclosing a preliminary budget for your consideration.

I

am

If I understand the proposal, it is to compare two drugs,
alone and canbined with a placebo. Ratings will be done prior
to drug administration, and after two and four weeks of treat—
ment. This is not to be a crossover study and so the number
of patients required will be at least 120. This indicates that
the patient flow in your clinic is indeed large.
From the EEG point of view, the number of subjects and the
sampling will be adequate. In these patients , one consideration
might be that an' initial record taken during the pre-treatment
period should be discarded. In naive subjects, an EEG recording
is often accompanied by considerable anxiety and this is best
alleviated by a recording and the overt demonstration that

it

is without risk.

if we plan

four recordings for each subject, the
500 useful records. From past
should anticipate approximately
we
with
experience
drop-cuts,
one—third more records than we need - for a total of 650 records.
I would like to know
If this is a realistic figure, thenadmissions
what
to the study are,
new
the
patient
approximately
number of
the
weekly
appraise
we
can realistically
so that
records required. The sample length will be determined, in part,
by the number of records to be run. Other things being equal,
I would suggest at least twelve minutes of recording with eyes
closed, and two minutes of eyes opened. The termination of each
recording might be a hyperventilation, with a two minute posteach instance , therecording Will
ation cord.
a east a to 10
ute settling period followed by
a 15 minute actual recording.
Thus,

on

study will have a minimum of

Wen?

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