Psychopharmacologic Investigations in Healthy Elderly Volunteers: Effects of Pipradrol‐Vitamin (Alertonic) Elixir and Placebo in Relation to Research Design†

Shader, Richard I.; Harmatz, Jerold S.; Kochansky, Gerald E.; Cole, Jonathan O.

doi:10.1111/j.1532-5415.1975.tb00318.x

Cited by 7 publications

(4 citation statements)

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“…Other tests, which gain their discriminating ability from graduated responses to more socially neutral items like appetite problems, are more likely to show the older respondents scoring higher than the young ones (16). Our own experience (1) supports the usefulness of the Zung self‐rated Depression Scale for purposes of preliminary screening. Similarly, our attempts to evaluate treatment‐induced short‐term affective states have shown that elderly people are much more comfortable using lists like the Depression Adjective Check List (17) than when using MMPI‐derived measures.…”

Section: Discussionsupporting

confidence: 52%

“…Recently the Psychopharmacology Research Laboratory (PRL) at Harvard Medical School began a series of investigations into the emotional effects of psychotropic drugs taken by elderly persons (1). In parallel work with younger volunteers, the importance of preliminary screening has been stressed; the screening methods included personality trait measures of anxiety and depression (2–4).…”

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confidence: 99%

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Psychopharmacologic Investigations in Healthy Elderly Volunteers: MMPI Depression Scale†

Harmatz

Shader

1975

J American Geriatrics Society

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The Depression Scale of the Minnesota Multiphasic Personality Inventory (MMPI) was used as a screening test for healthy volunteers in a psychopharmacologic research study. Data were collected on 43 men and 46 women under age 35 versus 33 men and 43 women over age 65 (plus a subsequent group of 40 men over age 65), and comparisons were made with more extensive data from the Mayo Clinic. The evidence indicates that elderly subjects differ strikingly from young subjects in their responses to items in the MMPI self-ratings of depression. Revised information on normative responses is needed. At present there are too many problems of interpretation when the Depression Scale items are applied to t.he elderly.

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Section: Discussionsupporting

confidence: 52%

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confidence: 99%

Psychopharmacologic Investigations in Healthy Elderly Volunteers: MMPI Depression Scale†

Harmatz

Shader

1975

J American Geriatrics Society

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“…The Zung scale was chosen because of the extensive work done with it in the area of geriatric depression 12 and because of reports attesting to its sensitivity to mild changes in affect in elderly patients. 13 These procedures were also administered by clinic staff members at the time of the neuropsychological assessment.…”

Section: Behavioral Assessmentmentioning

confidence: 99%

Treatment of hypertension in the elderly: II. Cognitive and behavioral function. Results of a Department of Veterans Affairs Cooperative Study.

et al. 1990

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This study was designed to determine whether blood pressure reduction, per se, causes adverse effects on cognitive and behavioral function in elderly hypertensive patients. Men with mild-to-moderate diastolic hypertension who had passed their 60th birthday were entered into the trial. After a placebo washout period, they were assigned in a randomized, double-blind manner to one of two groups receiving hydrochlorothiazide (either 25 mg once or twice daily or 50 mg once or twice daily). Responders entered a 1-year maintenance period. Nonresponders were randomly assigned to double-blind treatment with hydralazine, methyldopa, metoprolol, or reserpine added to the diuretic therapy. During the placebo and treatment periods, patients underwent a battery of psychometric tests designed to assess cognitive function, motor skills, memory, and affect. A separate questionnaire assessed the patient's ability to perform activities of daily living. A subset of patients blindly being treated with placebo received the same battery of tests as a control for practice effect. The results showed that there was similar improvement on the psychometric tests between those patients whose blood pressure was successfully reduced and the placebo-treated control group. Therefore, the practice effect did not obscure a true deterioration in function. There were no substantive differences between the lower and higher doses of diuretic or among the four drugs added to the diuretic, although there were qualitative differences in side effects. We conclude that blood pressure reduction, per se, does not adversely affect cognitive and behavioral function in elderly hypertensive patients and that antihypertensive treatment is safe and effective in these patients. (Hypertension 1990;15:361-369) E levated blood pressure in elderly patients can be safely and effectively reduced by using either hydrochlorothiazide (HCTZ) alone or, if necessary, by the addition of hydralazine, methyldopa, metoprolol, or reserpine to HCTZ.1 This paper addresses the perception that such blood pressure reduction in elderly patients may be associated with uncomfortable or even disabling side effects. by drug therapy. As part of the study detailed in part I, 1 we performed extensive psychometric testing to determine objectively the effect of treatment on cognitive function, motor skills, and memory. In addition, we assessed changes in affective state and activities of daily living. MethodsThe details of the design for this multicenter trial are presented in part I.1 Briefly, 690 men who had passed their 60th birthday and who met entry criteria for mild-to-moderate hypertension were randomly assigned to treatment with HCTZ (from 25 to 100 mg/day). Patients who achieved goal blood pressure of less than 90 mm Hg and at least a 5 mm Hg decline from baseline entered a 6-month maintenance period. Patients who did not achieve goal blood pressure were randomly assigned to treatment with by guest on May 11, 2018 http://hyper.ahajournals.org/ Downloaded from

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“…We studied a combination product containing pipradrol and vitamins. 8,9 We found the product to be ineffective. From my background reading for this Note, I was surprised to learn that pipradrol is listed as a Class A-prohibited drug for Olympic athletes.…”

Section: When Is a Signal A True Signal? Pemoline As A Confusing Casementioning

confidence: 82%

Risk Evaluation and Mitigation Strategies (REMS), Pemoline, and What Is a Signal?

Shader¹

2017

Clinical Therapeutics

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, MD, on the subject of pharmacovigilance and postmarketing surveillance. 1-5 In 2007 the Food and Drug Administration (FDA) was authorized to require sponsors to develop a Risk Evaluation and Mitigation Strategy (REMS) whenever there was a suspicion that more information might be needed to ensure the safety of a newly marketed product. 6 A REMS is an anticipatory risk management program intended to pick up unwanted drug effects once more patients are exposed to a drug than occurred during Phase II and III studies. This usually means that problems will be detected that require exposure of more than the typical 3000 to 5000 patients seen in the two pre-NDA (New Drug Application) phases. REMSs may also be important for agents for rare or orphan diseases. Such drugs have usually been marketed after an accelerated approval process, meaning that smaller numbers of patients were exposed before marketing approval. Also, real-world usage may reveal problems from other unstudied situations such as comorbidities or drug interactions. I created the mnemonic MICE to remember the main components of a REMS program. Table I lists the FDA's components in my rearranged order. For clinical safety purposes, the plans for implementation (eg, checking all databases, epidemiologic studies, creation of a registry) and communication (eg, a Dear Clinician letter) should occur early in the process of assuring safe use. The medication guide (an up-to-date version of a patient package insert) should flow from the planning efforts. Table II conveys an example of the types of information needed from patients included in a REMS. What the FDA cannot determine for the sponsor is what and how many unwanted events constitute a strong enough signal to initiate a full-blown REMS. This requires forthright discussions with the FDA, ideally initiated by the sponsor.

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Psychopharmacologic Investigations in Healthy Elderly Volunteers: Effects of Pipradrol‐Vitamin (Alertonic) Elixir and Placebo in Relation to Research Design†

Cited by 7 publications

References 6 publications

Psychopharmacologic Investigations in Healthy Elderly Volunteers: MMPI Depression Scale†

Psychopharmacologic Investigations in Healthy Elderly Volunteers: MMPI Depression Scale†

Treatment of hypertension in the elderly: II. Cognitive and behavioral function. Results of a Department of Veterans Affairs Cooperative Study.

Risk Evaluation and Mitigation Strategies (REMS), Pemoline, and What Is a Signal?

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